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14-Sep2018

Alembic Pharma gets USFDA's nod for Alogliptin, Metformin Hydrochloride Tablets

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Alogliptin and Metformin Hydrochloride Tablets, 12.5 mg/500 mg and 12.5 mg/1000 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), KAZANO Tablets, 12.5 mg/500 mg and 12.5 mg/1000 mg of Takeda Pharma USA. Alogliptin and Metformin Hydrochloride Tablets, 12.5 mg/500 mg and 12.5 mg/1000 mg are indicated as an adjunct to diet and exercise to improve giycemic control in adults with type 2 diabetes mellitus when treatment with both alogliptin and metformin is appropriate.

Alogliptin and Metformin Hydrochloride Tablets, 12.5 mg/500 mg and 12.5 mg/1000 mg has an estimated market size of $22.5 million for twelve months ending December 2017 according to IQVIA. Alembic now has a total of 77 ANDA approvals (64 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.


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