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Glenmark Pharma receives ANDA approval

Pratik Shastri
/ Categories: DSIJ Mindshare, DSIJ News
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Glenmark Pharma receives ANDA approval

Glenmark Pharmaceuticals received ANDA approval for Clindamycin and Benzoyl Peroxide Gel. The United States Food and Drug Administration (USFDA) gave Glenmark the final approval for Clindamycin and Benzoyl Peroxide Gel, a generic version of BenzaClin Gel of Valeant Bermuda.


According to IQVIATM sales data for the 12 month period ending January 2019, the BenzaClin Gel, market achieved annual sales of approximately US$99.4 million.


Abbreviated New Drug Application (ANDA) contains data that provides review and ultimate approval of a generic drug product. Glenmark Pharma currently has 151 products authorised for distribution in the US. In addition to this, it also has 53 ANDA approvals pending with USFDA.


Glenmark Pharma is a global biotech company which has significant presence in branded generic markets across five countries and has six research and development centres.


Stock reacted sharply to the news and touched its intraday high of Rs. 651.50. At 2:30, the stock showed gains of 1.28 per cent to trade at per share price of Rs. 638.45.

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