This is Glenmark’s first granted CGT product approved by the FDA.
Share price of Glenmark Pharmaadded nearly 4.8 percent intraday Monday after USFDA final approval for Hydrocortisone Valerate Ointment USP.
Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Hydrocortisone Valerate Ointment USP, 0.2%, a generic version of Westcort Ointment, 0.2%, of Sun Pharmaceutical Industries, Inc.
Glenmark has been granted a competitive generic therapy (CGT) designation for Hydrocortisone Valerate Ointment, therefore, with this approval, Glenmark is eligible for 180 days of CGT exclusivity upon commercialization.
This is Glenmark’s first granted CGT product approved by the FDA.
Company's current portfolio consists of 145 products authorized for distribution in the US marketplace and 55 ANDA’s pending approval with the USFDA.
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.
At 09:50 hrs Glenmark Pharma was quoting at Rs 691.90, up Rs 25.50, or 3.83 percent on the BSE.
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