Alembic Pharma share price hits 52-week high on tentative US FDA approval for diabetes drug

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26 Aug, 2025 12:21

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Alembic Pharmaceuticals share price touched 52-week high of Rs 1,038.40, rising over 6 percent on July 20 after company received tentative approval from the US Food and Drug Administration.

The company has received tentative approval from the US FDA 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, as per BSE release.

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Synjardy Tablets, 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg, of Boehringer lngelheim Pharmaceuticals, Inc. (Boehringer lngelheim).

Empagliflozin and Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin hydrochloride is appropriate, company added.

According to IQVIA, Empagliflozin and Metformin Hydrochloride Tablets have an estimated market size of USD 172 million for twelve months ending March 2020.

Alembic now has a total of 126 ANDA approvals (111 final approvals and 15 tentative approvals) from USFDA.

At 12:26 hrs, Alembic Pharmaceuticals was quoting at Rs 1,026.75, up Rs 49.85, or 5.10 percent on the BSE.