Alembic Pharmaceuticals Limited has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (4NDA) for Alogliptin and Metformin Hydrochloride Tablets, 12.5 mg/500 mg and 12.5 mg/100© 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 glycemic 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 US$ 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.
Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.640.2 as compared to the previous close of Rs. 608.65. The total number of shares traded during the day was 40346 in over 1583 trades.
The stock hit an intraday high of Rs. 657 and intraday low of 597.55. The net turnover during the day was Rs. 25772064.