Alembic Pharmaceuticals receives USFDA Tentative Approval for Alogliptin Tablets, 6.25 mg, 12.5 mg and 25 mg.

Deepthi | Myequity news | Date : 16-10-2018 12:50:00 IST

Alembic Pharmaceuticals Limited has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Alogliptin Tablets, 6.25 mg, 12.5 mg and 25mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), NESINA® Tablets, 6.25 mg, 12.5 mg and 25mg of Takeda Pharms USA.

Alogliptin Tablets, 6.25 mg, 12.5mg and 25mg are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and has an estimated market size of US$ 65.6 million for twelve months ending December 2017 according to IQVIA.


About Alembic Pharmaceuticals Limited:

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.


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