Alembic Pharmaceuticals receives USFDA Tentative Approval for Empagliflozin and Metformin Hydrochloride Tablets, 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg

Alembic Pharmaceuticals Limited today announced that the Company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Empagliflozin and Metformin Hydrochloride Tablets, 5 mg/500 mg, 5 mg/1000 mg, 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), Synjardy Tablets, 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer Ingelheim). Empagliflozin and Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin hydrochloride is appropriate.

Empagliflozin and Metformin Hydrochloride Tablets, 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg have an estimated market size of US$ 172 million for twelve months ending March 2020 according to IQVIA. Alembic is currently in litigation with Boehringer lngelheim in District Court of Delaware and launch of the product will depend on litigation outcome.

Alembic now has a total of 126 ANDA approvals (111 final approvals and 15 tentative approvals) from USFDA.

Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.976.9 as compared to the previous close of Rs. 970.9. The total number of shares traded during the day was 24882 in over 2562 trades.

The stock hit an intraday high of Rs. 989.8 and intraday low of 964.15. The net turnover during the day was Rs. 24239064.

Source : Equity Bulls

Keywords