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Alembic Pharma gets tentative approval for Empagliflozin, Metformin Hydrochloride Tablets

20 Jul 2020 Evaluate

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Empagliflozin and Metformin Hydrochloride Tablets, 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg.

Empagliflozin and Metformin Hydrochloride Tablets, 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg have an estimated market size of $172 million for twelve months ending March 2020. The company now has a total of 126 ANDA approvals (111 final approvals and 15 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

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