Glenmark Pharma gets USFDA nod for generic version of Micardis HCT tablets

The approved products is a generic version of Boehringer Ingelheim Pharmaceuticals Inc's Micardis HCT tablets. MICARDIS HCT (telmisartan and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure.

Mumbai: Glenmark Pharmaceuticals on Tuesday said it has received final approval from the US health regulator for Telmisartan and Hydrochlorothiazide tablets, used to treat high blood pressure (hypertension).

The approved products is a generic version of Boehringer Ingelheim Pharmaceuticals Inc's Micardis HCT tablets. MICARDIS HCT (telmisartan and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure.

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Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Telmisartan and Hydrochlorothiazide Tablets USP in the strengths of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg, the company said in a BSE filing.

Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization. Glenmark is a player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity).

The company has several molecules in various stages of clinical development and is focused in the areas of oncology, dermatology and respiratory. The company has a 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.