Hyderabad-based generic drug maker, Aurobindo Pharma Limited, has received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market Metformin Hydrochloride extended-release (ER) tablets in the US market, the company informed the Bombay Stock Exchange today.
The company is ready to launch the product, which is a generic equivalent of Bristol Myers Squibb Company (BMS)'s Glucophage XR tablets, used to treat patients with type-II diabetes. The annual sales for the product is approximately $230 million, the company said. The tablets are to be made available in 500 mg and 750 mg strengths.
Aurobindo now has a total of 153 ANDA (abbreviated new drug application) approvals, including one from Aurolife Pharma LLC, and 26 tentative approvals from the USFDA, according to the company.
The company’s scrip is currently trading at Rs 109.75 on the BSE, up 1.34 per cent, over the previous close of Rs 108.30.
