Glenmark Pharma gains 1% on tentative USFDA approval


Share price of Glenmark Pharma gained 1.4 percent intraday Thursday after company received tentative United States Food & Drug Administration (USFDA) approval.

Glenmark Pharmaceuticals Inc., USA has been granted tentative approval by the USFDA for Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, a generic version of QUDEXY1 XR Extended-Release Capsules, of Upsher-Smith Laboratories, LLC.

The QUDEXY XR Extended-Release Capsules achieved annual sales of approximately USD 84.0 million, as per IQVIATM sales data for the 12 month period ending November 2018.

Company’s current portfolio consists of 148 products authorized for distribution in the US marketplace and 54 ANDA’s pending approval with the USFDA, as per company release.

In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio, it added.

At 09:48 hrs Glenmark Pharma was quoting at Rs 657.50, up Rs 8, or 1.23 percent on the BSE.

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