Alembic Pharmaceuticals (Alembic) 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 Ingelheim 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 $3.4 billion for twelve months ending September 2019 according to IQVIA.
The company has a cumulative total of 112 ANDA approvals (99 final approvals and 13 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
