Alembic Pharma gains 3 per cent on tentative approval for diabetes drug

The shares of Alembic Pharma gained nearly 3 per cent during the early morning session on Thursday. The stock price got a further boost from the positive market sentiment and another drug approval from United States Food & Drug Administration (USFDA).

The pharma major on Thursday announced that it has received tentative approval from USFDA for Empagliflozin and Linagliptin tablets, 10 mg/5 mg, and 25 mg/5 mg. The drug is indicated in cases where the aim is to improve glycemic control in the second stage of diabetes adults. As per IQVIA estimates, Empagliflozin and Linagliptin tablets have a market size of USD 244 million.

The press release by the company, though, added that the Alembic is currently in litigation with Boehringer in District Court of Delaware. Hence, the final product launch is dependent on the outcome of this litigation. Alembic has a total of 130 ANDA approvals, out of which, 113 are final approvals while 17 have tentative approvals from USFDA.

The abbreviated new drug application (ANDA) is a major regulatory requirement for pharma companies. The application contains the data, which is to be submitted to FDA for the review. The potential approval validates the production of a generic drug. It allows the applicant to manufacture and sell the generic product.

The stock price surged 3.3 per cent to touch an intraday high of Rs 1,024 on BSE.