NEW DELHI, May 26: Glenmark Pharmaceuticals today said it has received final approval from the US health regulator for its generic version Olmesartan Medoxomil Tablets, used in treatment of high blood pressure.
The approval granted by the US Food and Drug Administration to Glenmark Pharmaceuticals Inc is for multiple strengths of 5 mg, 20 mg and 40 mg, the company said in a statement.
These are generic equivalent of Benicar Tablets of Daiichi Sankyo, Inc.
Glenmark’s Olmesartan Medoxomil tablets will be manufactured by the company’s manufacturing facility located in Goa, India, it added.
Citing IMS Health sales data for the 12-month period ended March 2017, the company said Benicar achieved annual sales of about USD 950 million.
Glenmark’s current portfolio consists of 115 products authorised for distribution in the US market and approximately 69 ANDA’s (Abbreviated New Drug Application) pending approval with the USFDA.
(PTI)
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