Alembic Pharma Share Price
Alembic Pharmaceuticals Ltd.
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About Alembic Pharma
Regarding human and animal medicine, Alembic Ltd is one of India's most trusted bulk medications and pharmaceutical formulation suppliers. They have been in business for almost a century, making them India's oldest pharmaceutical firm. They make it their business to boost living conditions and medical services in more than seventy nations. The company's production procedures and infrastructure are in accordance with WHO-GMP standards and has earned ISO-9002 and ISO-14001 certifications. Pharmaceutical and chemical formulations and bulk medications (including penicillin and other antibiotics) are produced.
Their plants may be found in Vadodara, Gujarat, and Solan, Himachal Pradesh. In 1907, Alembic Chemical Works Co Ltd was established in Vadodara to produce tinctures and alcohol under the name Alembic Ltd. In 1940, the production of cough syrup, vitamins, tonics, and sulphur drugs began. Penicillin Plant was opened in 1961. Production of streptomycin began in 1968.
Eli Lilly of the United States provided expertise in Erythromycin production in 1971, and in 1972, the company introduced Althrocin, a brand of Erythromycin. It was in the year 1997 when Althrocin surpassed all other brands in India. Production of Cephalosporin C began in 2001. Alembic International Ltd. established its UK-based subsidiary, Alembic Europe Pvt Ltd., in June 2001 as a wholly-owned subsidiary.
To capitalize on the booming market for lifestyle OTC products, the business entered in 2005 with the introduction of ZERO, a next-generation, calorie-free sugar substitute based on the sugar alcohol sucralose. In May 2005, the API division and generic alliances were combined to create a separate SBU. In Baddi, Himachal Pradesh, the business has established a formulation manufacturing plant with an annual output of 900 million pills and 600 million liquid oral bottles.
The company's installed capacity for tablets and capsules expanded by 595 million units during 2005–06, while the installed capacity for oral preparations and ointments climbed by 720 metric tons. In 2005-06, the firm purchased the API Plant in Karakhadi, Vadodara. The business purchased Dabur Pharma Ltd.'s Non-Oncology Business in 2007.
It also licensed its Novel Drug Delivery Platform for Keppra XR to UCB Belgium in the same year. In 2007–2008, the business bought Nirayu Pvt Ltd's API factory in Panelav, a city close to the city of Vadodara.Do you want to know more about Alembic Shares? Click Here to know about Alembic Share Price for today.
Their plants may be found in Vadodara, Gujarat, and Solan, Himachal Pradesh. In 1907, Alembic Chemical Works Co Ltd was established in Vadodara to produce tinctures and alcohol under the name Alembic Ltd. In 1940, the production of cough syrup, vitamins, tonics, and sulphur drugs began. Penicillin Plant was opened in 1961. Production of streptomycin began in 1968.
Eli Lilly of the United States provided expertise in Erythromycin production in 1971, and in 1972, the company introduced Althrocin, a brand of Erythromycin. It was in the year 1997 when Althrocin surpassed all other brands in India. Production of Cephalosporin C began in 2001. Alembic International Ltd. established its UK-based subsidiary, Alembic Europe Pvt Ltd., in June 2001 as a wholly-owned subsidiary.
To capitalize on the booming market for lifestyle OTC products, the business entered in 2005 with the introduction of ZERO, a next-generation, calorie-free sugar substitute based on the sugar alcohol sucralose. In May 2005, the API division and generic alliances were combined to create a separate SBU. In Baddi, Himachal Pradesh, the business has established a formulation manufacturing plant with an annual output of 900 million pills and 600 million liquid oral bottles.
The company's installed capacity for tablets and capsules expanded by 595 million units during 2005–06, while the installed capacity for oral preparations and ointments climbed by 720 metric tons. In 2005-06, the firm purchased the API Plant in Karakhadi, Vadodara. The business purchased Dabur Pharma Ltd.'s Non-Oncology Business in 2007.
It also licensed its Novel Drug Delivery Platform for Keppra XR to UCB Belgium in the same year. In 2007–2008, the business bought Nirayu Pvt Ltd's API factory in Panelav, a city close to the city of Vadodara.Do you want to know more about Alembic Shares? Click Here to know about Alembic Share Price for today.
Fundamentals of Alembic Pharma Shares
Market Cap |
P/E Ratio |
P/B Ratio |
Industry P/E |
|---|---|---|---|
Rs. 9522.50 Cr |
26.81 |
2.75 |
63.78 |
ROE |
EPS (TTM) |
Dividend Yield |
Book Value |
|---|---|---|---|
10.46 % |
27.65 |
1.35 % |
270.14 |
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What is the Market Cap of Alembic Pharmaceuticals Ltd. shares?
As of 27 Mar`23 the Market Cap of Alembic Pharmaceuticals Ltd. is 9522.50.
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As of 27 Mar`23 the PE is 26.81 and PB is 2.75.
Alembic Pharma - Quaterly Results
Publish Date: 11/11/2022
The revenue for the September 2022 quarter is pegged at Rs. 13544.20 millions, about 12.71% up against Rs. 12017.10 millions recorded during the year-ago period.Profit after tax improved marginally to Rs. 1464.40 millions for the quarter ended September 2022 from Rs. 1431.30 millions of corresponding previous quarter.Operating profit for the quarter ended September 2022 rose to 2457.60 millions as compared to 2352.20 millions of corresponding quarter ended September 2021.
(Rs. in Million) |
| Quarter ended | Year to Date | Year ended | |||||||
| 202209 | 202109 | % Var | 202209 | 202109 | % Var | 202203 | 202103 | % Var | |
| Sales | 13544.20 | 12017.10 | 12.71 | 25147.50 | 24714.00 | 1.75 | 49966.00 | 50514.40 | -1.09 |
| Other Income | 4.60 | 196.10 | -97.65 | 10.80 | 237.70 | -95.46 | 499.80 | 835.20 | -40.16 |
| PBIDT | 2457.60 | 2352.20 | 4.48 | 3730.10 | 5139.30 | -27.42 | 11044.30 | 15819.70 | -30.19 |
| Interest | 119.60 | 45.10 | 165.19 | 206.60 | 65.40 | 215.90 | 166.70 | 127.70 | 30.54 |
| PBDT | 2338.00 | 2307.10 | 1.34 | 3523.50 | 5073.90 | -30.56 | 10877.60 | 15692.00 | -30.68 |
| Depreciation | 668.00 | 542.20 | 23.20 | 1128.90 | 977.10 | 15.54 | 1793.10 | 1526.00 | 17.50 |
| PBT | 1670.00 | 1764.90 | -5.38 | 2394.60 | 4096.80 | -41.55 | 9084.50 | 14166.00 | -35.87 |
| TAX | 205.60 | 333.60 | -38.37 | 205.60 | 738.60 | -72.16 | 1144.50 | 2412.10 | -52.55 |
| Deferred Tax | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| PAT | 1464.40 | 1431.30 | 2.31 | 2189.00 | 3358.20 | -34.82 | 7940.00 | 11753.90 | -32.45 |
| Equity | 393.10 | 393.10 | 0.00 | 393.10 | 393.10 | 0.00 | 393.10 | 393.10 | 0.00 |
| PBIDTM(%) | 18.15 | 19.57 | -7.30 | 14.83 | 20.80 | -28.67 | 22.10 | 31.32 | -29.42 |
Alembic Pharma - Quaterly Results
Publish Date: 11/11/2022
The revenue zoomed 12.71% to Rs. 13544.20 millions for the quarter ended September 2022 as compared to Rs. 12017.10 millions during the corresponding quarter last year.Net profit showed a marginal rise at Rs. 1464.40 millions for the quarter ended September 2022, as compared to corresponding quarter of last year.The company reported a good operating profit of 2457.60 millions compared to 2352.20 millions of corresponding previous quarter.
(Rs. in Million) |
| Quarter ended | Year to Date | Year ended | |||||||
| 202209 | 202109 | % Var | 202209 | 202109 | % Var | 202203 | 202103 | % Var | |
| Sales | 13544.20 | 12017.10 | 12.71 | 25147.50 | 24714.00 | 1.75 | 49966.00 | 50514.40 | -1.09 |
| Other Income | 4.60 | 196.10 | -97.65 | 10.80 | 237.70 | -95.46 | 499.80 | 835.20 | -40.16 |
| PBIDT | 2457.60 | 2352.20 | 4.48 | 3730.10 | 5139.30 | -27.42 | 11044.30 | 15819.70 | -30.19 |
| Interest | 119.60 | 45.10 | 165.19 | 206.60 | 65.40 | 215.90 | 166.70 | 127.70 | 30.54 |
| PBDT | 2338.00 | 2307.10 | 1.34 | 3523.50 | 5073.90 | -30.56 | 10877.60 | 15692.00 | -30.68 |
| Depreciation | 668.00 | 542.20 | 23.20 | 1128.90 | 977.10 | 15.54 | 1793.10 | 1526.00 | 17.50 |
| PBT | 1670.00 | 1764.90 | -5.38 | 2394.60 | 4096.80 | -41.55 | 9084.50 | 14166.00 | -35.87 |
| TAX | 205.60 | 333.60 | -38.37 | 205.60 | 738.60 | -72.16 | 1144.50 | 2412.10 | -52.55 |
| Deferred Tax | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| PAT | 1464.40 | 1431.30 | 2.31 | 2189.00 | 3358.20 | -34.82 | 7940.00 | 11753.90 | -32.45 |
| Equity | 393.10 | 393.10 | 0.00 | 393.10 | 393.10 | 0.00 | 393.10 | 393.10 | 0.00 |
| PBIDTM(%) | 18.15 | 19.57 | -7.30 | 14.83 | 20.80 | -28.67 | 22.10 | 31.32 | -29.42 |
Alembic Pharma - Quaterly Results
Publish Date: 11/11/2022
The revenue zoomed 12.71% to Rs. 13544.20 millions for the quarter ended September 2022 as compared to Rs. 12017.10 millions during the corresponding quarter last year.Net profit showed a marginal rise at Rs. 1464.40 millions for the quarter ended September 2022, as compared to corresponding quarter of last year.The company reported a good operating profit of 2457.60 millions compared to 2352.20 millions of corresponding previous quarter.
(Rs. in Million) |
| Quarter ended | Year to Date | Year ended | |||||||
| 202209 | 202109 | % Var | 202209 | 202109 | % Var | 202203 | 202103 | % Var | |
| Sales | 13544.20 | 12017.10 | 12.71 | 25147.50 | 24714.00 | 1.75 | 49966.00 | 50514.40 | -1.09 |
| Other Income | 4.60 | 196.10 | -97.65 | 10.80 | 237.70 | -95.46 | 499.80 | 835.20 | -40.16 |
| PBIDT | 2457.60 | 2352.20 | 4.48 | 3730.10 | 5139.30 | -27.42 | 11044.30 | 15819.70 | -30.19 |
| Interest | 119.60 | 45.10 | 165.19 | 206.60 | 65.40 | 215.90 | 166.70 | 127.70 | 30.54 |
| PBDT | 2338.00 | 2307.10 | 1.34 | 3523.50 | 5073.90 | -30.56 | 10877.60 | 15692.00 | -30.68 |
| Depreciation | 668.00 | 542.20 | 23.20 | 1128.90 | 977.10 | 15.54 | 1793.10 | 1526.00 | 17.50 |
| PBT | 1670.00 | 1764.90 | -5.38 | 2394.60 | 4096.80 | -41.55 | 9084.50 | 14166.00 | -35.87 |
| TAX | 205.60 | 333.60 | -38.37 | 205.60 | 738.60 | -72.16 | 1144.50 | 2412.10 | -52.55 |
| Deferred Tax | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| PAT | 1464.40 | 1431.30 | 2.31 | 2189.00 | 3358.20 | -34.82 | 7940.00 | 11753.90 | -32.45 |
| Equity | 393.10 | 393.10 | 0.00 | 393.10 | 393.10 | 0.00 | 393.10 | 393.10 | 0.00 |
| PBIDTM(%) | 18.15 | 19.57 | -7.30 | 14.83 | 20.80 | -28.67 | 22.10 | 31.32 | -29.42 |
Alembic Pharma - Quaterly Results
Publish Date: 01/02/2023
The Revenue for the quarter ended December 2022 of Rs. 13102.10 millions grew by 5.84 % from Rs. 12379.50 millions.The Net Profit of the company slipped to Rs. 1191.30 millions from Rs. 1768.00 millions, a decline of -32.62% on QoQ basis.The company reported a degrowth in operating Profit to 2248.10 millions from 2743.50 millions.
(Rs. in Million) |
| Quarter ended | Year to Date | Year ended | |||||||
| 202212 | 202112 | % Var | 202212 | 202112 | % Var | 202203 | 202103 | % Var | |
| Sales | 13102.10 | 12379.50 | 5.84 | 38249.60 | 37093.50 | 3.12 | 49966.00 | 50514.40 | -1.09 |
| Other Income | 5.90 | 153.10 | -96.15 | 16.70 | 390.80 | -95.73 | 499.80 | 835.20 | -40.16 |
| PBIDT | 2248.10 | 2743.50 | -18.06 | 5978.20 | 7882.80 | -24.16 | 11044.30 | 15819.70 | -30.19 |
| Interest | 146.50 | 43.90 | 233.71 | 353.10 | 109.30 | 223.06 | 166.70 | 127.70 | 30.54 |
| PBDT | 2101.60 | 2699.60 | -22.15 | 5625.10 | 7773.50 | -27.64 | 10877.60 | 15692.00 | -30.68 |
| Depreciation | 658.50 | 557.10 | 18.20 | 1787.40 | 1534.20 | 16.50 | 1793.10 | 1526.00 | 17.50 |
| PBT | 1443.10 | 2142.50 | -32.64 | 3837.70 | 6239.30 | -38.49 | 9084.50 | 14166.00 | -35.87 |
| TAX | 251.80 | 374.50 | -32.76 | 457.40 | 1113.10 | -58.91 | 1144.50 | 2412.10 | -52.55 |
| Deferred Tax | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| PAT | 1191.30 | 1768.00 | -32.62 | 3380.30 | 5126.20 | -34.06 | 7940.00 | 11753.90 | -32.45 |
| Equity | 393.10 | 393.10 | 0.00 | 393.10 | 393.10 | 0.00 | 393.10 | 393.10 | 0.00 |
| PBIDTM(%) | 17.16 | 22.16 | -22.58 | 15.63 | 21.25 | -26.45 | 22.10 | 31.32 | -29.42 |
Alembic Pharma - Quaterly Results
Publish Date: 01/02/2023
The revenue for the December 2022 quarter is pegged at Rs. 13102.10 millions, about 5.84% up against Rs. 12379.50 millions recorded during the year-ago period.Net profit of the cmpany stood at Rs. 1191.30 millions for the quarter ended December 2022 a decline of -32.62% from Rs. 1768.00 millions in the same quarter last year.Operating Profit reported a sharp decline to 2248.10 millions from 2743.50 millions in the corresponding previous quarter.
(Rs. in Million) |
| Quarter ended | Year to Date | Year ended | |||||||
| 202212 | 202112 | % Var | 202212 | 202112 | % Var | 202203 | 202103 | % Var | |
| Sales | 13102.10 | 12379.50 | 5.84 | 38249.60 | 37093.50 | 3.12 | 49966.00 | 50514.40 | -1.09 |
| Other Income | 5.90 | 153.10 | -96.15 | 16.70 | 390.80 | -95.73 | 499.80 | 835.20 | -40.16 |
| PBIDT | 2248.10 | 2743.50 | -18.06 | 5978.20 | 7882.80 | -24.16 | 11044.30 | 15819.70 | -30.19 |
| Interest | 146.50 | 43.90 | 233.71 | 353.10 | 109.30 | 223.06 | 166.70 | 127.70 | 30.54 |
| PBDT | 2101.60 | 2699.60 | -22.15 | 5625.10 | 7773.50 | -27.64 | 10877.60 | 15692.00 | -30.68 |
| Depreciation | 658.50 | 557.10 | 18.20 | 1787.40 | 1534.20 | 16.50 | 1793.10 | 1526.00 | 17.50 |
| PBT | 1443.10 | 2142.50 | -32.64 | 3837.70 | 6239.30 | -38.49 | 9084.50 | 14166.00 | -35.87 |
| TAX | 251.80 | 374.50 | -32.76 | 457.40 | 1113.10 | -58.91 | 1144.50 | 2412.10 | -52.55 |
| Deferred Tax | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| PAT | 1191.30 | 1768.00 | -32.62 | 3380.30 | 5126.20 | -34.06 | 7940.00 | 11753.90 | -32.45 |
| Equity | 393.10 | 393.10 | 0.00 | 393.10 | 393.10 | 0.00 | 393.10 | 393.10 | 0.00 |
| PBIDTM(%) | 17.16 | 22.16 | -22.58 | 15.63 | 21.25 | -26.45 | 22.10 | 31.32 | -29.42 |
Alembic Pharma rises on getting USFDA's final approval for Chlorthalidone Tablets
Publish Date: 29/08/2022
The company has a cumulative total of 171 ANDA approvals from USFDA
Alembic Pharmaceuticals is currently trading at Rs. 656.00, up by 5.60 points or 0.86% from its previous closing of Rs. 650.40 on the BSE.
The scrip opened at Rs. 644.35 and has touched a high and low of Rs. 662.15 and Rs. 642.85 respectively. So far 3159 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 863.10 on 12-Oct-2021 and a 52 week low of Rs. 641.80 on 23-Aug-2022.
Last one week high and low of the scrip stood at Rs. 665.50 and Rs. 641.80 respectively. The current market cap of the company is Rs. 12949.58 crore.
The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 18.09% and 12.30% respectively.
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Chlorthalidone Tablets USP, 25 mg and 50 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).
Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or; to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.
Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of $ 37 million for twelve months ending June, 2022 according to IQVIA. Alembic has a cumulative total of 171 ANDA approvals (147 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals informs about press release
Publish Date: 29/08/2022
Alembic Pharmaceuticals has informed that the Company has received US Food & Drug Administration (USFDA) Final Approval for Chlorthalidone Tablets USP, 25 mg and 50 mg. The Company has enclosed press release.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals informs about company updates
Publish Date: 29/08/2022
Alembic Pharmaceuticals has informed that the Company has successfully completed the US Food and Drug Administration (USFDA) Remote Regulatory Assessment (RRA) for its Bioequivalence Facility, Bio-analytical division, located at Vadodara, without any observations. The RRA was conducted from 22nd August, 2022 to 26th August, 2022.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals informs about newspaper publication
Publish Date: 16/09/2022
Pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, Alembic Pharmaceuticals has informed that it enclosed a copy of the advance notice published in English and vernacular language (Gujarati) newspaper on 16th September, 2022 in Economic Times and Indian Express, English Edition and Financial Express Gujarati Edition, in compliance with Ministry of Corporate Affair's General Circular No. 20/2020 dated 5th May, 2020 inter alia informing the members that the 12th Annual General Meeting of the Company will be held on Friday, the 11th November, 2022 through Video Conferencing ('VC') / Other Audio Visual Means ('OAVM').
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals informs about AGM
Publish Date: 19/09/2022
Pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, Alembic Pharmaceuticals has informed that it enclosed Notice of 12th Annual General Meeting of the Members of the Company scheduled to be held on Friday, the 11th November, 2022 at 3:00 pm IST through Video Conferencing (VC) / Other Audio Visual Means (OAVM).
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals informs about loss of share certificate
Publish Date: 27/09/2022
Alembic Pharmaceuticals has informed that it enclosed the intimation dated 27th September, 2022 received from Link lntime India, Registrar and Share Transfer Agent, regarding receipt of the request(s)/application(s) from the registered shareholder(s) of the Company for issue of Duplicate Share Certificate(s).
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals informs about updates
Publish Date: 18/10/2022
Alembic Pharmaceuticals has informed the United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals’ Oncology Injectable Formulation Facility located at Panelav from 4th October, 2022 to 14th October, 2022. The USFDA issued a Form 483 with 4 procedural observations. None of the observations are related to data integrity and management believes that they are addressable. The Company is preparing the response to the observations, which will be submitted to the USFDA within stipulated period. The Company is committed to maintain the highest quality standards and compliance at all times.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals informs about disclosure
Publish Date: 25/10/2022
Alembic Pharmaceuticals has informed the exchange that the Company has successfully completed the United States Food and Drug Administration (USFDA) inspection for its Bioequivalence Facility located at Vadodara without any observations. The inspection was conducted from 17th October, 2022 to 21st October, 2022.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals informs about press release
Publish Date: 27/10/2022
Alembic Pharmaceuticals has informed the exchange that the company has received US Food & Drug Administration (USFDA) Final Approval for Paclitaxel Injection USP, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL) Multiple-Dose Vials. The company has enclosed a press release in this regard.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals gains on getting final nod for Paclitaxel Injection from USFDA
Publish Date: 27/10/2022
The company has a cumulative total of 172 ANDA approvals (148 final approvals and 24 tentative approvals) from USFDA
Alembic Pharmaceuticals is currently trading at Rs. 549.20, up by 1.05 points or 0.19% from its previous closing of Rs. 548.15 on the BSE.
The scrip opened at Rs. 551.25 and has touched a high and low of Rs. 552.35 and Rs. 542.50 respectively. So far 7803 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 847.95 on 04-Jan-2022 and a 52 week low of Rs. 541.10 on 20-Oct-2022.
Last one week high and low of the scrip stood at Rs. 559.70 and Rs. 541.10 respectively. The current market cap of the company is Rs. 10814.90 crore.
The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 17.87% and 12.52% respectively.
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paclitaxel Injection USP, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL) Multiple-Dose Vials. This is the first product approval for oncology injection from F-2 Facility (Oncology Injectable) which recently completed the first USFDA inspection.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Taxol Injection, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL). Paclitaxel Injection USP, has an estimated market size of $26 million for twelve months ending June 2022. Alembic has a cumulative total of 172 ANDA approvals (148 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals informs about press release
Publish Date: 01/11/2022
Alembic Pharmaceuticals has informed the exchange that the Company has received US Food & Drug Administration (USFDA) Final Approval for Glycopyrrolate Injection USP, 0.2 mg/1 mL and 0.4 mg/2 mL (0.2 mg/mL) Single-dose Vials and 1 mg/5 mL (0.2 mg/mL) and 4 mg/20 mL (0.2 mg/mL) Multiple-dose Vials. In this regard, the company has enclosed a press release.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals gains on getting USFDA’s approval for Glycopyrrolate Injection
Publish Date: 01/11/2022
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022
Alembic Pharmaceuticals is currently trading at Rs. 553.30, up by 3.35 points or 0.61% from its previous closing of Rs. 549.95 on the BSE.
The scrip opened at Rs. 552.70 and has touched a high and low of Rs. 557.95 and Rs. 550.00 respectively. So far 3408 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 847.95 on 04-Jan-2022 and a 52 week low of Rs. 541.10 on 20-Oct-2022.
Last one week high and low of the scrip stood at Rs. 560.00 and Rs. 542.50 respectively. The current market cap of the company is Rs. 10849.30 crore.
The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 17.87% and 12.52% respectively.
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Glycopyrrolate Injection USP, 0.2 mg/1 mL and 0.4 mg/2 mL (0.2 mg/mL) Single-dose Vials and 1 mg/5 mL (0.2 mg/mL) and 4 mg/20 mL (0.2 mg/mL) Multiple-dose Vials. This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), of Hikma Pharmaceuticals USA Inc. (Hikma). Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation.
Glycopyrrolate Injection USP, has an estimated market size of $ 42 million for twelve months ending June 2022 according to IQVIA. Alembic has a cumulative total of 173 ANDA approvals (149 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals informs about press release
Publish Date: 02/11/2022
Alembic Pharmaceuticals has informed the exchange that the Company has received US Food & Drug Administration (USFDA) Final Approval for Mesalamine Extended-Release Capsules USP, 0.375 g. In this regard, the company has enclosed a press release.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals moves up on getting final approval for Mesalamine Extended-Release Capsules from USFDA
Publish Date: 02/11/2022
Mesalamine Extended-Release Capsules USP, 0.375 g, have an estimated market size of $133 million for twelve months ending June 2022
Alembic Pharmaceuticals is currently trading at Rs. 602.05, up by 23.60 points or 4.08% from its previous closing of Rs. 578.45 on the BSE.
The scrip opened at Rs. 580.35 and has touched a high and low of Rs. 602.00 and Rs. 574.90 respectively. So far 14552 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 847.95 on 04-Jan-2022 and a 52 week low of Rs. 541.10 on 20-Oct-2022.
Last one week high and low of the scrip stood at Rs. 604.00 and Rs. 542.50 respectively. The current market cap of the company is Rs. 11811.48 crore.
The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 17.87% and 12.52% respectively.
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mesalamine Extended-Release Capsules USP, 0.375 g. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Apriso Extended-Release Capsules, 0.375 g, of Salix Pharmaceuticals, Inc. (Salix). Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
Mesalamine Extended-Release Capsules USP, 0.375 g, have an estimated market size of $133 million for twelve months ending June 2022 according to IQVIA. The company has a cumulative total of 174 ANDA approvals (150 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals zooms on getting final nod for Ketorolac Tromethamine Injection
Publish Date: 03/11/2022
Ketorolac Tromethamine Injection USP has an estimated market size of $59 million for twelve months ending June 2022
Alembic Pharmaceuticals is currently trading at Rs. 661.55, up by 49.35 points or 8.06% from its previous closing of Rs. 612.20 on the BSE.
The scrip opened at Rs. 608.70 and has touched a high and low of Rs. 675.00 and Rs. 603.55 respectively. So far 143890 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 847.95 on 04-Jan-2022 and a 52 week low of Rs. 541.10 on 20-Oct-2022.
Last one week high and low of the scrip stood at Rs. 675.00 and Rs. 548.00 respectively. The current market cap of the company is Rs. 12802.16 crore.
The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 17.87% and 12.52% respectively.
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL (30 mg/mL) Single Dose Vials. This is the second injectable product approval from company’s General Sterile Facility (F-3) which was inspected in August, 2022.
Ketorolac Tromethamine Injection USP has an estimated market size of $59 million for twelve months ending June 2022 according to IQVIA. The company has a cumulative total of 175 ANDA approvals (151 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals informs about press release
Publish Date: 03/11/2022
Alembic Pharmaceuticals has informed the exchange that the Company has received US Food & Drug Administration (USFDA) Final Approval for Ketorolac Tromethamine Injection USP, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL (30 mg/mL) Single Dose Vials. In this regard, the company has enclosed its press release.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals informs about conference call
Publish Date: 09/11/2022
Alembic Pharmaceuticals has informed that the Company's Post Results Conference Call will be held on 11th November, 2022 at 5:30 pm, as per the revised details enclosed.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals jumps on getting USFDA’s approval for Cyclophosphamide Capsules
Publish Date: 15/11/2022
Cyclophosphamide Capsules have an estimated market size of $ 8 million for twelve months ending Sep 2022 according to IQVIA
Alembic Pharmaceuticals is currently trading at Rs. 647.70, up by 8.40 points or 1.31% from its previous closing of Rs. 639.30 on the BSE.
The scrip opened at Rs. 641.50 and has touched a high and low of Rs. 651.25 and Rs. 640.40 respectively. So far 3600 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 847.95 on 04-Jan-2022 and a 52 week low of Rs. 541.10 on 20-Oct-2022.
Last one week high and low of the scrip stood at Rs. 651.25 and Rs. 604.85 respectively. The current market cap of the company is Rs. 12734.34 crore.
The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 17.87% and 12.52% respectively.
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Cyclophosphamide Capsules, 25 mg and 50 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cyclophosphamide Capsules, 25 mg and 50 mg, of Hikma Pharmaceuticals USA Inc. Cyclophosphamide Capsules is an alkylating drug indicated for the treatment of malignant disease and minimal change nephrotic syndrome in pediatric patients.
Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of $ 8 million for twelve months ending Sep 2022 according to IQVIA. Alembic has a cumulative total of 176 ANDA approvals (152 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals informs about loss of share certificates
Publish Date: 16/11/2022
Alembic Pharmaceuticals has informed that it enclosed the intimation dated 16th November, 2022 received from Link lntime India, Registrar and Share Transfer Agent, regarding receipt of the request(s)/ application(s) from the registered shareholder(s) of the Company for issue of Duplicate Share Certificate(s).
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals gains on getting USFDA’s nod for Nifedipine Extended-Release Tablets
Publish Date: 21/11/2022
Alembic has a cumulative total of 177 ANDA approvals from USFDA
Alembic Pharmaceuticals is currently trading at Rs. 630.75, up by 5.40 points or 0.86% from its previous closing of Rs. 625.35 on the BSE.
The scrip opened at Rs. 617.05 and has touched a high and low of Rs. 634.70 and Rs. 617.05 respectively. So far 755 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 847.95 on 04-Jan-2022 and a 52 week low of Rs. 541.10 on 20-Oct-2022.
Last one week high and low of the scrip stood at Rs. 651.25 and Rs. 617.05 respectively. The current market cap of the company is Rs. 12370.70 crore.
The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 17.87% and 12.52% respectively.
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg and 90 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Procardia XL Extended-Release Tablets, 30 mg, 60 mg and 90 mg, of Pfizer Inc.
Nifedipine Extended-Release Tablets are indicated for the management of i) Vasospastic Angina ii) Chronic Stable Angina (Classical Effort-Associated Angina) and iii) Hypertension. Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg and 90 mg, have an estimated market size of $ 56 million for twelve months ending Sep 2022 according to IQVIA. Alembic has a cumulative total of 177 ANDA approvals (153 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals informs about analyst meet
Publish Date: 25/11/2022
Pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, Alembic Pharmaceuticals has informed that the management of the Company shall be meeting analysts/investors through NBIE Virtual Investor Meeting hosted by Nirmal Bang Institutional Equities on 25th November, 2022.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals informs about loss of share certificate
Publish Date: 28/11/2022
Alembic Pharmaceuticals has informed that it enclosed the intimation dated 27th November, 2022 received from Link lntime India, Registrar and Share Transfer Agent, regarding receipt of the request(s)/application(s) from the registered shareholder(s) of the Company for issue of Duplicate Share Certificate(s).
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals informs about issue of duplicate certificate
Publish Date: 29/11/2022
Alembic Pharmaceuticals has informed that it enclosed the intimation dated 29th November, 2022 received from Link lntime India, Registrar and Share Transfer Agent, regarding receipt of the request(s)/application(s) from the registered shareholder(s) of the Company for issue of Duplicate Share Certificate(s).
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals informs about press release
Publish Date: 01/12/2022
Alembic Pharmaceuticals has informed the exchange that the Company has received US Food & Drug Administration (USFDA) Final Approval for Diclofenac Sodium Topical Solution USP, 2% w/w. In this regard, the company has enclosed a press release.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals surges on getting USFDA’s final approval for Diclofenac Sodium Topical Solution
Publish Date: 01/12/2022
Diclofenac Sodium Topical Solution is indicated for the treatment of the pain of osteoarthritis of the knee(s)
Alembic Pharmaceuticals is currently trading at Rs. 597.95, up by 2.95 points or 0.50% from its previous closing of Rs. 595.00 on the BSE.
The scrip opened at Rs. 593.00 and has touched a high and low of Rs. 606.50 and Rs. 593.00 respectively. So far 2940 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 847.95 on 04-Jan-2022 and a 52 week low of Rs. 541.10 on 20-Oct-2022.
Last one week high and low of the scrip stood at Rs. 607.00 and Rs. 591.30 respectively. The current market cap of the company is Rs. 11756.44 crore.
The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 17.87% and 12.52% respectively.
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Diclofenac Sodium Topical Solution USP, 2% w/w. The ANDA was filed by Aleor Dermaceuticals Limited (Aleor) which was amalgamated with Alembic. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pennsaid Topical Solution, 2% w/w, of Horizon Therapeutics Ireland DAC (Horizon). Diclofenac Sodium Topical Solution is indicated for the treatment of the pain of osteoarthritis of the knee(s).
Aleor had previously received tentative approval for this ANDA. Diclofenac Sodium Topical Solution USP, 2% w/w has an estimated market size of $512 million for twelve months ending Sep 2022 according to IQVIA. Alembic has received a cumulative total of 177 ANDA approvals (154 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals informs about issuance of duplicate share certificate
Publish Date: 02/12/2022
Alembic Pharmaceuticals has informed that it enclosed the intimation dated 2nd December, 2022 received from Linklntime India, Registrar and Share Transfer Agent, regarding receipt of the request(s)/application(s) from the registered shareholder(s) of the Company for issue of Duplicate Share Certificate(s).
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals informs about disclosure
Publish Date: 19/12/2022
Alembic Pharmaceuticals has informed that the United States Food and Drug Administration (USFDA) has conducted PAI (Pre-Approval Inspection) at Alembic Pharmaceuticals' Solid Oral Formulation Facility (F-4) located at Jarod. The USFDA issued a Form 483 with 5 procedural observations. None of the observations are related to data integrity and management believes that they are addressable. The Company is preparing the response to the observations, which will be submitted to the USFDA within stipulated period. The Company is committed to maintain the highest quality standards and compliance at all times.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals rises on receiving PAS approval from USFDA for Pregabalin Capsules
Publish Date: 23/12/2022
Alembic has a cumulative total of 178 ANDA approvals from USFDA
Alembic Pharmaceuticals is currently trading at Rs. 589.85, up by 1.20 points or 0.20% from its previous closing of Rs. 588.65 on the BSE.
The scrip opened at Rs. 586.60 and has touched a high and low of Rs. 600.00 and Rs. 584.10 respectively. So far 1917 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 847.95 on 04-Jan-2022 and a 52 week low of Rs. 541.10 on 20-Oct-2022.
Last one week high and low of the scrip stood at Rs. 607.95 and Rs. 568.00 respectively. The current market cap of the company is Rs. 11743.66 crore.
The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 17.87% and 12.52% respectively.
Alembic Pharmaceuticals has received PAS (Prior Approval Supplement) approval from the US Food & Drug Administration (USFDA) for its Supplemental Abbreviated New Drug Application (sANDA) Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg.
The sANDA, submitted as ;Prior Approval Supplement’, provides for an alternate drug product manufacturing site - Alembic Pharmaceuticals, Formulation Division IV, Jarod, Gujarat, India for previously approved ANDA from Panelav Facility (F-I). This is the first product approval from Jarod Facility which was inspected in Dec 2022. The approved sANDA is therapeutically equivalent to the reference listed drug product (RLD), Lyrica Capsules, of Upjohn. Pregabalin Capsules are indicated for neuropathic pain, postherpetic neuralgia, and other indications.
Pregabalin Capsules have an estimated market size of $ 244 million for twelve months ending Sep 2022 according to IQVIA. Alembic has a cumulative total of 178 ANDA approvals (155 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals informs about press release
Publish Date: 26/12/2022
Alembic Pharmaceuticals has informed the exchange that the Company has received US Food & Drug Administration (USFDA) Final Approval for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-Dose Prefilled Syringe. The company has enclosed its press release.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals gains on getting nod for Fulvestrant Injection from USFDA
Publish Date: 26/12/2022
The company has received a cumulative total of 179 ANDA approvals (156 final approvals and 23 tentative approvals) from USFDA
Alembic Pharmaceuticals is currently trading at Rs. 587.10, up by 5.50 points or 0.95% from its previous closing of Rs. 581.60 on the BSE.
The scrip opened at Rs. 572.05 and has touched a high and low of Rs. 592.65 and Rs. 572.05 respectively. So far 1034 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 847.95 on 04-Jan-2022 and a 52 week low of Rs. 541.10 on 20-Oct-2022.
Last one week high and low of the scrip stood at Rs. 607.95 and Rs. 568.00 respectively. The current market cap of the company is Rs. 11432.11 crore.
The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 17.87 % and 12.52 % respectively.
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per SingleDose Prefilled Syringe. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Faslodex Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals LP. Fulvestrant Injection is an estrogen receptor antagonist indicated for the treatment of breast cancer.
Fulvestrant Injection, 250 mg/5 mL, has an estimated market size of $71 million for twelve months ending September 2022 according to IQVIA. Alembic has received a cumulative total of 179 ANDA approvals (156 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals jumps on receiving USFDA’s tentative approval for Acalabrutinib Capsules
Publish Date: 19/01/2023
Acalabrutinib Capsules, 100 mg, have an estimated market size of $1.5billion for twelve months ending Sep 2022 according to IQVIA
Alembic Pharmaceuticals is currently trading at Rs. 559.15, up by 6.75 points or 1.22% from its previous closing of Rs. 552.40 on the BSE.
The scrip opened at Rs. 553.50 and has touched a high and low of Rs. 560.80 and Rs. 553.50 respectively. So far 1483 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 793.75 on 19-Jan-2022 and a 52 week low of Rs. 541.10 on 20-Oct-2022.
Last one week high and low of the scrip stood at Rs. 564.00 and Rs. 550.70 respectively. The current market cap of the company is Rs. 10990.83 crore.
The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 17.87% and 12.52% respectively.
Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Acalabrutinib Capsules, 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Calquence Capsules, 100 mg, of AstraZeneca UK Limited (AstraZeneca). Acalabrutinib Capsules are indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Acalabrutinib Capsules, 100 mg, have an estimated market size of $1.5billion for twelve months ending Sep 2022 according to IQVIA. Alembic has a cumulative total of 180 ANDA approvals (157 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals informs about details of loss of certificate
Publish Date: 01/02/2023
Alembic Pharmaceuticals has informed that it enclosed the intimation dated 1st February, 2023 received from Link lntime India, Registrar and Share Transfer Agent, regarding receipt of the request(s)/application(s) from the registered shareholder(s) of the Company for issue of Duplicate Share Certificate(s).
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals informs about updates
Publish Date: 16/02/2023
Alembic Pharmaceuticals has informed that the Company has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for the inspection carried out by them at its Injectable Facility (F-3) at Karkhadi from 18th August, 2022 to 30th August, 2022. This was a pre-approval inspection for ANDAs filed with the USFDA. The Company has already started receiving ANDA approvals manufactured at this facility.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals submits analyst meet intimation
Publish Date: 17/02/2023
Pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, Alembic Pharmaceuticals has informed that the management of the Company shall be meeting analysts/investors through Chasing Growth Conference hosted by Kotak Securities on 20th February, 2023.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals informs about loss of share certificate
Publish Date: 23/02/2023
Alembic Pharmaceuticals has informed that it enclosed the intimation dated 23rd February, 2023 received from Link lntime India, Registrar and Share Transfer Agent, regarding receipt of the request(s)/application(s) from the registered shareholder(s) of the Company and/or their legal heir(s) for issue of Duplicate Share Certificate(s).
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals informs about press release
Publish Date: 01/03/2023
Alembic Pharmaceuticals has informed that the Company has received US Food & Drug Administration (USFDA) Final Approval for Docetaxel Injection USP, 20 mg/2 mL (10 mg/mL) Single-Dose Vial, and 80 mg/8 mL (10 mg/mL) and 160 mg/16 mL (10 mg/mL) Multiple-Dose Vials. It enclosed the press release.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals informs about press release
Publish Date: 06/03/2023
Alembic Pharmaceuticals has informed the exchange that the Company has received US Food & Drug Administration (USFDA) Final Approval for Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Pharmacy Bulk Vial. In this regard, the company has enclosed a press release.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals spurts on getting USFDA’s final approval for Fluorouracil Injection
Publish Date: 06/03/2023
Alembic has a cumulative total of 182 ANDA approvals (159 final approvals and 23 tentative approvals) from USFDA
Alembic Pharmaceuticals is currently trading at Rs. 516.90, up by 15.35 points or 3.06% from its previous closing of Rs. 501.55 on the BSE.
The scrip opened at Rs. 509.35 and has touched a high and low of Rs. 516.90 and Rs. 507.70 respectively. So far 1760 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 792.30 on 28-Apr-2022 and a 52 week low of Rs. 476.30 on 03-Mar-2023.
Last one week high and low of the scrip stood at Rs. 529.10 and Rs. 476.30 respectively. The current market cap of the company is Rs. 9987.37 crore.
The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 17.75% and 12.64% respectively.
Alembic Pharmaceuticals (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Pharmacy Bulk Vial. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Fluorouracil Injection, 2.5 g/50 mL (50 mg/mL), of Spectrum Pharmaceuticals, Inc. (Spectrum).
Fluorouracil Injection is indicated for the treatment of patients with adenocarcinoma of colon and rectum, adenocarcinoma of the breast, gastric adenocarcinoma and pancreatic adenocarcinoma.
Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Vial, has an estimated market size of $5 million for twelve months ending December 2022 according to IQVIA. Alembic has a cumulative total of 182 ANDA approvals (159 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals informs about press release
Publish Date: 08/03/2023
Alembic Pharmaceuticals has informed the exchange that the Company has received US Food & Drug Administration (USFDA) Final Approval for Prazosin Hydrochloride Capsules USP, 1 mg, 2 mg, and 5 mg. In this regard, the company has enclosed its press release.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals rises on getting USFDA's tentative approval for Brexpiprazole Tablets
Publish Date: 09/03/2023
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of $1.6 billion for twelve months ending December 2022
Alembic Pharmaceuticals is currently trading at Rs. 519.05, up by 6.75 points or 1.32% from its previous closing of Rs. 512.30 on the BSE.
The scrip opened at Rs. 512.55 and has touched a high and low of Rs. 519.05 and Rs. 512.55 respectively. So far 331 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 792.30 on 28-Apr-2022 and a 52 week low of Rs. 476.30 on 03-Mar-2023.
Last one week high and low of the scrip stood at Rs. 528.45 and Rs. 476.30 respectively. The current market cap of the company is Rs. 10069.93 crore.
The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 17.75% and 12.64% respectively.
Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, of Otsuka Pharmaceutical (Otsuka). Brexpiprazole Tablets are indicated as an adjunctive therapy to antidepressants for the treatment of major depressive disorder and for treatment of schizophrenia. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of $1.6 billion for twelve months ending December 2022. Alembic has a cumulative total of 184 ANDA approvals (160 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals informs about press release
Publish Date: 09/03/2023
Alembic Pharmaceuticals has informed the exchange that the Company has received US Food & Drug Administration (USFDA) Tentative Approval for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg. In this regard, the company has enclosed its press release.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals informs about updates
Publish Date: 13/03/2023
Alembic Pharmaceuticals has informed the exchange that the Company has successfully completed the United States Food and Drug Administration (USFDA) inspection for its Derma Facility located at Karakhadi without any observations. The inspection was conducted from 6th March, 2023 to 10th March, 2023.
The above information is a part of company’s filings submitted to BSE.
Alembic Pharmaceuticals trades higher on completing USFDA’s inspection at Derma Facility without any observations
Publish Date: 14/03/2023
The inspection was conducted from March 6, 2023 to March 10, 2023
Alembic Pharmaceuticals is currently trading at Rs. 490.50, up by 3.20 points or 0.66% from its previous closing of Rs. 487.30 on the BSE.
The scrip opened at Rs. 496.55 and has touched a high and low of Rs. 496.55 and Rs. 484.65 respectively. So far 2454 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 792.30 on 28-Apr-2022 and a 52 week low of Rs. 476.30 on 03-Mar-2023.
Last one week high and low of the scrip stood at Rs. 524.75 and Rs. 482.50 respectively. The current market cap of the company is Rs. 9557.88 crore.
The promoters holding in the company stood at 69.61 % while Institutions and Non-Institutions held 17.75 % and 12.64 % respectively.
Alembic Pharmaceuticals has successfully completed the United States Food and Drug Administration (USFDA) inspection for its Derma Facility located at Karakhadi without any observations. The inspection was conducted from March 6, 2023 to March 10, 2023.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Board Meeting
Publish Date: 01/02/2023
Quarterly Results
Ex Dividend
Publish Date: 17/08/2022
Interim Dividend
Board Meeting
Publish Date: 04/08/2022
Quarterly Results & Interim Dividend
Board Meeting
Publish Date: 02/05/2022
Audited Results & Dividend
Board Meeting
Publish Date: 10/02/2022
Quarterly Results
Board Meeting
Publish Date: 10/11/2021
Quarterly Results
Board Meeting
Publish Date: 26/07/2021
Quarterly Results
Ex Dividend
Publish Date: 19/07/2021
Rs.14.0000 per share(700%)Dividend
Alembic Pharmaceuticals gets USFDA's final approval for Chlorthalidone Tablets
Publish Date: 29/08/2022
The company has a cumulative total of 171 ANDA approvals from USFDA
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Chlorthalidone Tablets USP, 25 mg and 50 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).
Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or ; to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.
Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of $ 37 million for twelve months ending June, 2022 according to IQVIA. Alembic has a cumulative total of 171 ANDA approvals (147 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
USFDA concludes inspection at Alembic Pharma’s injectable facility at Gujarat
Publish Date: 01/09/2022
The company is committed to maintain the highest quality standards and compliance at all times
United States Food and Drug Administration (USFDA) has concluded inspection at Alembic Pharmaceuticals’ Injectable Facility (F-3) located at Karkhadi, Gujarat. USFDA has conducted inspection from August 18, 2022 to August 30, 2022 and issued Form 483 with 2 observations. None of the observations are related to data integrity and management believes that they are addressable. The company is preparing the response to the observations, which will be submitted to the USFDA within stipulated period. The company is committed to maintain the highest quality standards and compliance at all times.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals gets 4 observations from USFDA for Panelav facility
Publish Date: 18/10/2022
The Company is committed to maintain the highest quality standards and compliance at all times
United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals’ Oncology Injectable Formulation Facility located at Panelav. The inspection was conducted from October 4, 2022 to October 14, 2022. The USFDA issued a Form 483 with 4 procedural observations. None of the observations are related to data integrity and management believes that they are addressable. The Company is preparing the response to the observations, which will be submitted to the USFDA within stipulated period. The Company is committed to maintain the highest quality standards and compliance at all times.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
USFDA concludes inspection at Alembic Pharmaceuticals’ Bioequivalence facility
Publish Date: 25/10/2022
The inspection was conducted from October 17, 2022 to October 21, 2022
United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals’ Bioequivalence facility located at Vadodara. The inspection was conducted from October 17, 2022 to October 21, 2022. The company has successfully completed USFDA inspection without any observations.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals gets final nod for Paclitaxel Injection from USFDA
Publish Date: 27/10/2022
The company has a cumulative total of 172 ANDA approvals (148 final approvals and 24 tentative approvals) from USFDA
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paclitaxel Injection USP, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL) Multiple-Dose Vials. This is the first product approval for oncology injection from F-2 Facility (Oncology Injectable) which recently completed the first USFDA inspection.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Taxol Injection, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL). Paclitaxel Injection USP, has an estimated market size of $26 million for twelve months ending June 2022. Alembic has a cumulative total of 172 ANDA approvals (148 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals gets USFDA’s approval for Glycopyrrolate Injection USP
Publish Date: 01/11/2022
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Glycopyrrolate Injection USP, 0.2 mg/1 mL and 0.4 mg/2 mL (0.2 mg/mL) Single-dose Vials and 1 mg/5 mL (0.2 mg/mL) and 4 mg/20 mL (0.2 mg/mL) Multiple-dose Vials. This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), of Hikma Pharmaceuticals USA Inc. (Hikma). Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation.
Glycopyrrolate Injection USP, has an estimated market size of $ 42 million for twelve months ending June 2022 according to IQVIA. Alembic has a cumulative total of 173 ANDA approvals (149 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals gets final approval for Mesalamine Extended-Release Capsules from USFDA
Publish Date: 02/11/2022
Mesalamine Extended-Release Capsules USP, 0.375 g, have an estimated market size of $133 million for twelve months ending June 2022
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mesalamine Extended-Release Capsules USP, 0.375 g. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Apriso Extended-Release Capsules, 0.375 g, of Salix Pharmaceuticals, Inc. (Salix). Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
Mesalamine Extended-Release Capsules USP, 0.375 g, have an estimated market size of $133 million for twelve months ending June 2022 according to IQVIA. The company has a cumulative total of 174 ANDA approvals (150 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals gets final nod for Ketorolac Tromethamine Injection
Publish Date: 03/11/2022
Ketorolac Tromethamine Injection USP has an estimated market size of $59 million for twelve months ending June 2022
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL (30 mg/mL) Single Dose Vials. This is the second injectable product approval from company’s General Sterile Facility (F-3) which was inspected in August, 2022.
Ketorolac Tromethamine Injection USP has an estimated market size of $59 million for twelve months ending June 2022 according to IQVIA. The company has a cumulative total of 175 ANDA approvals (151 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals gets USFDA’s final approval for Cyclophosphamide Capsules
Publish Date: 14/11/2022
Cyclophosphamide Capsules have an estimated market size of $ 8 million for twelve months ending Sep 2022 according to IQVIA
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Cyclophosphamide Capsules, 25 mg and 50 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cyclophosphamide Capsules, 25 mg and 50 mg, of Hikma Pharmaceuticals USA Inc. Cyclophosphamide Capsules is an alkylating drug indicated for the treatment of malignant disease and minimal change nephrotic syndrome in pediatric patients.
Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of $ 8 million for twelve months ending Sep 2022 according to IQVIA. Alembic has a cumulative total of 176 ANDA approvals (152 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals reports 19% fall in Q2 consolidated net profit
Publish Date: 14/11/2022
Total consolidated income of the company increased by 12.35% at Rs 1475.34 crore for Q2FY23
Alembic Pharmaceuticals has reported results for second quarter ended September 30, 2022.
The company has reported a rise of 2.31% in its net profit at Rs 146.44 crore for the quarter under review as compared to Rs 143.13 crore for the same quarter in the previous year. Total income of the company increased by 10.94% at Rs 1354.88 crore for Q2FY23 as compared Rs 1221.32 crore for the corresponding quarter previous year.
On the consolidated basis, the company has reported fall of 18.68% in its net profit at Rs 133.35 crore for the quarter under review as compared to Rs 163.99 crore for the same quarter in the previous year. However, total income of the company increased by 12.35% at Rs 1475.34 crore for Q2FY23 as compared Rs 1313.19 crore for the corresponding quarter previous year.
Alembic Pharmaceuticals gets USFDA’s approval for Nifedipine Extended-Release Tablets
Publish Date: 21/11/2022
Alembic has a cumulative total of 177 ANDA approvals from USFDA
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg and 90 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Procardia XL Extended-Release Tablets, 30 mg, 60 mg and 90 mg, of Pfizer Inc.
Nifedipine Extended-Release Tablets are indicated for the management of i) Vasospastic Angina ii) Chronic Stable Angina (Classical Effort-Associated Angina) and iii) Hypertension. Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg and 90 mg, have an estimated market size of $ 56 million for twelve months ending Sep 2022 according to IQVIA. Alembic has a cumulative total of 177 ANDA approvals (153 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals gets USFDA’s final approval for Diclofenac Sodium Topical Solution
Publish Date: 01/12/2022
Diclofenac Sodium Topical Solution is indicated for the treatment of the pain of osteoarthritis of the knee(s)
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Diclofenac Sodium Topical Solution USP, 2% w/w. The ANDA was filed by Aleor Dermaceuticals Limited (Aleor) which was amalgamated with Alembic. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pennsaid Topical Solution, 2% w/w, of Horizon Therapeutics Ireland DAC (Horizon). Diclofenac Sodium Topical Solution is indicated for the treatment of the pain of osteoarthritis of the knee(s).
Aleor had previously received tentative approval for this ANDA. Diclofenac Sodium Topical Solution USP, 2% w/w has an estimated market size of $512 million for twelve months ending Sep 2022 according to IQVIA. Alembic has received a cumulative total of 177 ANDA approvals (154 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals gets USFDA’s final approval for Desonide Cream
Publish Date: 09/12/2022
The ANDA was filed by Aleor Dermaceuticals which was amalgamated with Alembic
Alembic Pharmaceuticals (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Desonide Cream, 0.05%. The ANDA was filed by Aleor Dermaceuticals (Aleor) which was amalgamated with Alembic. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Desonide Cream, 0.05%, of Padagis US. Desonide Cream, 0.05% is a Low potency corticosteroid indicated for the relief of inflammatory and Pruritic manifestations of corticosteroid-responsive dermatoses.
Desonide Cream, 0.05%, has an estimated market size of US$12 million for twelve months ending Sep 2022 according to IQVIA. The company has received a cumulative total of 178 ANDA approvals from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
USFDA issues EIR to Alembic Pharmaceuticals’ Oncology Injectable Formulation facility at Panelav
Publish Date: 09/12/2022
The Company had also started receiving ANDA approval manufactured at this facility
Alembic Pharmaceuticals has received Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for the inspection carried out by USFDA at company’s Oncology Injectable Formulation facility at Panelav during the period from October 04, 2022 to October 14, 2022. This was preapproval inspection to cover company’s Oncology Injectable drug products for which ANDAs were filed with USFDA. The Company had also started receiving ANDA approval manufactured at this facility.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
USFDA conducts pre-approval inspection at Alembic Pharmaceuticals’ Jarod facility
Publish Date: 19/12/2022
The USFDA issued a Form 483 with 5 procedural observations
The United States Food and Drug Administration (USFDA) has conducted PAI (Pre-Approval Inspection) at Alembic Pharmaceuticals’ Solid Oral Formulation Facility (F-4) located at Jarod. The USFDA issued a Form 483 with 5 procedural observations.
None of the observations are related to data integrity and management believes that they are addressable. The Company is preparing the response to the observations, which will be submitted to the USFDA within stipulated period. The Company is committed to maintain the highest quality standards and compliance at all times.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals receives PAS approval from USFDA for Pregabalin Capsules
Publish Date: 22/12/2022
Alembic has a cumulative total of 178 ANDA approvals from USFDA
Alembic Pharmaceuticals has received PAS (Prior Approval Supplement) approval from the US Food & Drug Administration (USFDA) for its Supplemental Abbreviated New Drug Application (sANDA) Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg.
The sANDA, submitted as ;Prior Approval Supplement’, provides for an alternate drug product manufacturing site - Alembic Pharmaceuticals, Formulation Division IV, Jarod, Gujarat, India for previously approved ANDA from Panelav Facility (F-I). This is the first product approval from Jarod Facility which was inspected in Dec 2022. The approved sANDA is therapeutically equivalent to the reference listed drug product (RLD), Lyrica Capsules, of Upjohn. Pregabalin Capsules are indicated for neuropathic pain, postherpetic neuralgia, and other indications.
Pregabalin Capsules have an estimated market size of $ 244 million for twelve months ending Sep 2022 according to IQVIA. Alembic has a cumulative total of 178 ANDA approvals (155 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals gets final nod for Fulvestrant Injection from USFDA
Publish Date: 26/12/2022
The company has received a cumulative total of 179 ANDA approvals (156 final approvals and 23 tentative approvals) from USFDA
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per SingleDose Prefilled Syringe. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Faslodex Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals LP. Fulvestrant Injection is an estrogen receptor antagonist indicated for the treatment of breast cancer.
Fulvestrant Injection, 250 mg/5 mL, has an estimated market size of $71 million for twelve months ending September 2022 according to IQVIA. Alembic has received a cumulative total of 179 ANDA approvals (156 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals gets USFDA’s final nod for Fesoterodine Fumarate Extended-Release Tablets
Publish Date: 06/01/2023
Alembic has a cumulative total of 179 ANDA approvals (157 final approvals and 22 tentative approvals) from USFDA
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Toviaz Extended-Release Tablets, 4 mg and 8 mg, of Pfizer Inc. (Pfizer). Fesoterodine Fumarate Extended-Release Tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.
Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, have an estimated market size of $177 million for twelve months ending Sep 2022 according to IQVIA. Alembic had previously received tentative approval for this ANDA. Alembic has a cumulative total of 179 ANDA approvals (157 final approvals and 22 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals receives USFDA’s tentative approval for Acalabrutinib Capsules
Publish Date: 19/01/2023
Acalabrutinib Capsules, 100 mg, have an estimated market size of $1.5billion for twelve months ending Sep 2022 according to IQVIA
Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Acalabrutinib Capsules, 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Calquence Capsules, 100 mg, of AstraZeneca UK Limited (AstraZeneca). Acalabrutinib Capsules are indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Acalabrutinib Capsules, 100 mg, have an estimated market size of $1.5billion for twelve months ending Sep 2022 according to IQVIA. Alembic has a cumulative total of 180 ANDA approvals (157 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals reports 29% fall in Q3 consolidated net profit
Publish Date: 02/02/2023
Total consolidated income of the company increased by 17.29% to Rs 1,509.46 crore for Q3FY23
Alembic Pharmaceuticals has reported results for third quarter ended December 31, 2022.
The company has reported fall of 32.62% in its net profit at Rs 119.13 crore for Q3FY23 as compared to Rs 176.80 crore for the corresponding quarter previous year. However, total income of the company increased by 4.59% to Rs 1,310.80 crore for the quarter under review as compared to Rs 1,253.26 crore for the same quarter in the previous year.
On the consolidated basis, the company has reported fall of 29.03% in its net profit at Rs 121.92 crore for Q3FY23 as compared to Rs 171.79 crore for the same quarter in the previous year. However, total income of the company increased by 17.29% to Rs 1,509.46 crore for the quarter under review as compared to Rs 1,286.96 crore for the same quarter in the previous year.
Alembic Pharmaceuticals receives EIR for Injectable Facility at Karkhadi
Publish Date: 16/02/2023
The company has already started receiving ANDA approvals manufactured at this facility
Alembic Pharmaceuticals has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for the inspection carried out by them at its Injectable Facility (F-3) at Karkhadi from August 18, 2022 to August 30, 2022. This was a pre-approval inspection for ANDAs filed with the USFDA. The company has already started receiving ANDA approvals manufactured at this facility.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals gets USFDA’s final approval for Docetaxel Injection
Publish Date: 01/03/2023
Alembic has a cumulative total of 181 ANDA approvals (158 final approvals and 23 tentative approvals) from USFDA
Alembic Pharmaceuticals (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Docetaxel Injection USP, 20 mg/2 mL (10 mg/mL) Single-Dose Vial, and 80 mg/8 mL (10 mg/mL) and 160 mg/16 mL (10 mg/mL) Multiple-Dose Vials.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Docetaxel Injection, 20 mg/2 mL, 80 mg/8 mL, and 160 mg/16 mL (10 mg/mL), of Hospira, Inc. Docetaxcel Injections are indicated for the breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of head and neck.
Docetaxel Injection USP, 20 mg/2 mL (10 mg/mL) Single-Dose Vial, and 80 mg/8 mL (10 mg/mL) and 160 mg/16 mL (10 mg/mL) Multiple-Dose Vials, have an estimated market size of $11 million for twelve months ending December 2022 according to IQVIA. Alembic has a cumulative total of 181 ANDA approvals (158 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals gets USFDA’s final approval for Fluorouracil Injection
Publish Date: 06/03/2023
Alembic has a cumulative total of 182 ANDA approvals (159 final approvals and 23 tentative approvals) from USFDA
Alembic Pharmaceuticals (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Pharmacy Bulk Vial. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Fluorouracil Injection, 2.5 g/50 mL (50 mg/mL), of Spectrum Pharmaceuticals, Inc. (Spectrum).
Fluorouracil Injection is indicated for the treatment of patients with adenocarcinoma of colon and rectum, adenocarcinoma of the breast, gastric adenocarcinoma and pancreatic adenocarcinoma.
Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Vial, has an estimated market size of $5 million for twelve months ending December 2022 according to IQVIA. Alembic has a cumulative total of 182 ANDA approvals (159 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharma gets USFDA's final approval for Prazosin Hydrochloride Capsules
Publish Date: 08/03/2023
Prazosin Hydrochloride Capsule is indicated for the treatment of hypertension, to lower blood pressure
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Prazosin Hydrochloride Capsules USP, 1 mg, 2 mg, and 5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Minipress Capsules, 1 mg, 2 mg, and 5 mg, of Pfizer Inc. Prazosin Hydrochloride Capsule is indicated for the treatment of hypertension, to lower blood pressure.
Prazosin Hydrochloride Capsules USP, 1 mg, 2 mg, and 5 mg have an estimated market size of $50 million for twelve months ending Dec 2022 according to IQVIA. Alembic has a cumulative total of 183 ANDA approvals (160 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals gets USFDA's tentative approval for Brexpiprazole Tablets
Publish Date: 09/03/2023
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of $1.6 billion for twelve months ending December 2022
Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, of Otsuka Pharmaceutical (Otsuka). Brexpiprazole Tablets are indicated as an adjunctive therapy to antidepressants for the treatment of major depressive disorder and for treatment of schizophrenia. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of $1.6 billion for twelve months ending December 2022. Alembic has a cumulative total of 184 ANDA approvals (160 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Alembic Pharmaceuticals completes USFDA’s inspection at Derma Facility
Publish Date: 13/03/2023
The inspection was conducted from March 6, 2023 to March 10, 2023
Alembic Pharmaceuticals has successfully completed the United States Food and Drug Administration (USFDA) inspection for its Derma Facility located at Karakhadi without any observations. The inspection was conducted from March 6, 2023 to March 10, 2023.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
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