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Alembic Pharmaceuticals surges on securing USFDA’s final approval for ‘Dapagliflozin Tablets’

The company is eligible for 180 days of shared generic drug exclusivity

Alembic Pharmaceuticals is currently trading at Rs. 681.40, up by 25.25 points or 3.85 % from its previous closing of Rs. 656.15 on the BSE.

The scrip opened at Rs. 654.80 and has touched a high and low of Rs. 683.30 and Rs. 653.00 respectively. So far 8313 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 1107.80 on 30-Jun-2025 and a 52 week low of Rs. 635.30 on 23-Mar-2026.

Last one week high and low of the scrip stood at Rs. 713.85 and Rs. 644.15 respectively. The current market cap of the company is Rs. 13393.81 crore.

The promoters holding in the company stood at 69.74%, while Institutions and Non-Institutions held 20.41% and 9.86% respectively.

Alembic Pharmaceuticals has secured final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dapagliflozin Tablets, 5 mg and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB (AstraZeneca). Dapagliflozin tablet is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. It is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The company was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Dapagliflozin Tablets, 5 mg and 10 mg. Therefore, with this approval, the company is eligible for 180 days of shared generic drug exclusivity. The company has a cumulative total of 235 ANDA approvals (217 final approvals and 18 tentative approvals) from USFDA.

Alembic Pharmaceuticals is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.