Glenmark Pharma receives final approval from USFDA for antiplatelet drug

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Glenmark Pharmaceuticals Monday said it has received final approval from the US health regulator for antiplatelet agents Aspirin and extended-release Dipyridamole capsules.

The approved product is a generic version of Aggrenox capsules of Boehringer Ingelheim Pharmaceuticals Inc.

Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Aspirin and extended-release Dipyridamole capsules in the strength of 25 mg/200 mg, the company said in a BSE filing.

Citing IQVIA sales data, Glenmark said, the Aggrenox capsules, 25 mg/200 mg market achieved annual sales of approximately USD 165.6 million in the 12-month period ended March 2019.

The company said its current portfolio consists of 155 products authorised for distribution in the US and 58 Abbreviated New Drug Application (ANDA's) pending approval with the USFDA.

Shares of Glenmark Pharma were trading 0.03 per cent higher at Rs 559.20 apiece on the BSE.


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