Glenmark diabetes management drug Metformin Hydrochloride ER tablets get USFDA nod

The product is a generic version of Glumetza 1 Extended‐Release Tablets, 500 mg and 1000 mg, of Salix Pharmaceuticals Inc, Glenmark said in a BSE filing.

Mumbai: Glenmark Pharmaceuticals Inc., USA (Glenmark) recently announced that the company has been granted final approval by the United States Food & Drug Administration (USFDA) for Metformin Hydrochloride Extended‐Release Tablets USP, 500 mg and 1000 mg used in the management of Type-2 Diabetes.

The product is a generic version of Glumetza Extended‐Release Tablets, 500 mg and 1000 mg, of Salix Pharmaceuticals Inc, Glenmark said in a BSE filing.

According to IQVIATM sales data for the 12‐month period ending September 2019, the Glumetza Tablets, 500 mg and 1000 mg market2 achieved annual sales of approximately $226.7 million*.

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Glenmark’s current portfolio consists of 164 products authorized for distribution in the U.S. marketplace and 44 ANDA’s pending approval with the U.S. FDA.

The company has a significant presence in the branded generics markets across emerging economies including India. It has 16 manufacturing facilities across five countries and has six R&D centres. The Generics business of Glenmark services the requirements of the US and Western European markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India.

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