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Glenmark Pharma arm gets final USFDA approval for blood pressure drug

The approval granted to Glenmark Pharmaceuticals Inc, USA by the United States Food & Drug Administration (USFDA) is for Bisoprolol Fumarate and Hydrochlorothiazide tablets of strengths 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 MG, the company said in a statement.

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Glenmark said its current portfolio consists of 172 products authorised for distribution in the US marketplace and 46 abbreviated new drug applications pending approval with the USFDA.

Glenmark Pharmaceuticals Ltd on Thursday said its US subsidiary has received final approval from the country’s health regulator for its generic Bisoprolol Fumarate and Hydrochlorothiazide tablets used to treat high blood pressure.

The approval granted to Glenmark Pharmaceuticals Inc, USA by the United States Food & Drug Administration (USFDA) is for Bisoprolol Fumarate and Hydrochlorothiazide tablets of strengths 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 MG, the company said in a statement.

These are generic versions of Ziac tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, of Teva Branded Pharmaceutical Products R&D, Inc, it added.

Citing IQVIATM sales data for the 12 months ending November 2021, the company said these Ziac tablets had annual sales of approximately USD 30.3 million.

Glenmark said its current portfolio consists of 172 products authorised for distribution in the US marketplace and 46 abbreviated new drug applications pending approval with the USFDA.

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