Last Updated : Wednesday, January 15, 2020 15:32:41

ALEMBIC PHARMA gets USFDA nod to market anti-diabetic drug

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Vadodara headquartered Indian Pharmaceutical products manufacturing major – Alembic Pharmaceuticals Ltd said of having got tentative approval for marketing anti-diabetic drug – Empagliflozin Tablets in dosages of 10 mg (milligram) and 25 mg, primely aimed to substitute diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The release titled, “Alembic Pharmaceuticals receives USFDA Tentative Approval for Empagliflozin Tablets, 10 mg and 25 mg”, further read that, Alembic Pharmaceuticals Limited (Alembic) today announced that the Company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Empagliflozin Tablets, 10 mg and 25 mg.


The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Jardiance Tablets, 10 mg and 25 mg, of Boehringer lngelheim Pharmaceuticals, Inc. (Boehringer).

Emapgliflozin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Emapgliflozin Tablets have an estimated market size of US$ 3.4 billion for twelve months ending September 2019 according to IQVIA.

Alembic has a cumulative total of 112 AN DA approvals (99 final approvals and 13 tentative approvals) from USFDA.

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