Alogliptin and Metformin Hydrochloride tablets got tentative market approval from USFDA. It is used as the diabetes drug.
New Delhi: Alembic Pharmaceuticals said it has received tentative approval from the US health regulator to market Alogliptin and Metformin Hydrochloride tablets, an anti-diabetes medication, in the US market. The company’s product is a generic version of Takeda PharmaUSA’s Kazano tablets, Alembic Pharmaceuticals said in a regulatory filing.
Alembic Pharmaceuticals Ltd. is an Indian multinational pharmaceutical company headquartered in Vadodara city of Gujarat. Alogliptin and Metformin Hydrochloride tablets had an estimated market size of USD 22.5 million in the US for 12 months ending December 2017, according to the market data.
Alembic now has a total of 77 abbreviated new drug application (ANDA) approvals from the USFDA.