Glenmark Pharma receives final USFDA nod for hypertension drug
- Country:
- India
Glenmark Pharmaceuticals 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.
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. Quoting IQVIA sales data for the 12 month period ending January 2019, Glenmark said the Micardis HCT tablets market achieved annual sales of approximately USD 40.6 million.
The company's current portfolio consists of 150 products authorised for distribution at the US marketplace and 52 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA. The company's stock was trading at 1.71 per cent higher at Rs 607.50 apiece on BSE.
(With inputs from agencies.)
ALSO READ
Multiple people critically injured in massive explosion and fire at French oil products factory
Two HPCL assistant managers booked for pilfering petroleum products worth Rs 5.82 crore
ALP Polymer Park positions itself as premier export destination for polymer products
Godrej Locks eyes 50 pc market share; bets big on new cheaper products, price cuts of existing ones
CCPA calls for FSSAI investigation into allegations of Nestle putting sugar in baby products