Glenmark Pharma gets ANDA approval for Ranolazine

Glenmark Pharmaceuticals Inc. has received final approval from United States Food & Drug Administration (USFDA) for Ranolazine Extended-Release Tablets, 500 mg and 1,000 mg.

Ranolazine Extended-Release Tablets, 500 mg and 1,000 mg is a generic version of Ranexa Extended-Release Tablets, 500 mg and 1,000 mg of Gilead Sciences, Inc. Its annual sales for the twelve month period ended May 2019 in a press release are reported to be approximately US$929 million which includes retail and non-retail sales. Currently, Glenmark has 158 products which are authorised for distribution in the US markets. More 57 ANDAs are pending for approval from the USFDA.

Glenmark Pharmaceuticals Ltd., which is headquartered in Mumbai is a pharmaceutical company manufacturing generic drugs and active pharmaceutical ingredients. The company also contributes towards identifying and exploring external partnerships which can accelerate and support its growth in the product range. Last month, USFDA had raised concerns over the company’s new application drug for Ryaltris used for treating allergic rhinitis thus delaying the launch of the drug in the US markets. It has also partnered with Novartis for promotion, commercialisation and distribution of three respiratory products in Brazil.

On Tuesday, the stock of Glenmark Pharmaceuticals was trading at Rs. 451.40 per share, up by 3.35 per cent or Rs. 14.65 per share. The 52-week high being Rs. 711.55 and 52-week low being Rs. 423.70 on BSE.