Alembic Pharma gains 4% on USFDA nod for key diabetes drug

Shares of Alembic Pharmaceuticals Ltd. rose over 4% on Tuesday, April 7, after the company received final approval from the US Food and Drug Administration (USFDA) for its Dapagliflozin tablets in 5 mg and 10 mg strengths.

The tablets are used for treating type 2 diabetes and related cardiovascular conditions.

The approval is for the company’s abbreviated new drug application (ANDA) and is therapeutically equivalent to AstraZeneca’s Farxiga, a widely used SGLT2 inhibitor, the company said in an exchange filing.

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According to Alembic, it was among the first applicants to file a substantially complete ANDA with a paragraph IV certification, making it eligible for 180 days of shared generic drug exclusivity in the US market.

IQVIA data shows that the approved drug has an estimated market size of $10.49 billion for the 12 months ending December 2025, proving a significant commercial opportunity.

Dapagliflozin is prescribed to improve glycaemic control in adults with type 2 diabetes and to reduce the risk of hospitalisation for heart failure in patients with cardiovascular risk factors.

With this approval, Alembic’s cumulative tally now stands at 235 ANDA approvals from the USFDA, including 217 final approvals and 18 tentative approvals.

The company, which has a strong presence in the US generics market, continues to expand its portfolio of complex and speciality products backed by its research and manufacturing capabilities.

Shares of Alembic Pharma gained 4.12% and hit an intraday high of ₹683, following the announcement. The stock has pared some gains since and was trading 2.93% up at ₹675.15 as of 1.05 pm. However, it has declined more than 26% over the past six months.