Alembic Pharmaceuticals Receives USFDA Final Approval for Dapagliflozin Tablets

Alembic Pharmaceuticals Receives USFDA Final Approval for Dapagliflozin Tablets​

Alembic Pharmaceuticals Limited announced today that it has secured final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dapagliflozin Tablets, available in strengths of 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, manufactured by AstraZeneca AB. Dapagliflozin tablet, which is an SGLT2 inhibitor, is indicated for two uses. It is 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. Additionally, it is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

This approval is significant as Alembic was among the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Dapagliflozin Tablets, 5 mg and 10 mg. Consequently, this approval makes Alembic eligible for 180 days of shared generic drug exclusivity.

Market analysis suggests that Dapagliflozin tablets, 5 mg and 10 mg, have an estimated market size of US$ 10,487 million for a twelve-month period ending December 2025, according to IQVIA.

Alembic Pharmaceuticals Limited has a cumulative record of 235 ANDA approvals from the USFDA, comprising 217 final approvals and 18 tentative approvals.

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company with a history in healthcare dating back to 1907. Headquartered in India, the publicly listed company manufactures and markets generic pharmaceutical products globally. The company’s state-of-the-art research and manufacturing facilities hold approvals from regulatory authorities in numerous developed countries, including the USFDA. Alembic is noted as a leader in branded generics within India, with its brands marketed through a field force of over 5500.

APLLTD Stock Price Movement​

Shares of Alembic Pharmaceuticals Limited are edging higher to ₹669.65 as of 12:26 PM today, rallying 2.09% in live trading. Trading volume stands at 24,008 shares, keeping the stock well within its intraday range of ₹652.15 to ₹670.

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