Glenmark pharma gets ANDA approval for Hydrocortisone Valerate Ointment USP, 0 2 pc

Hydrocortisone Valerate Ointment is Glenmark's first granted competitive generic therapy(CGT) product approved by the FDA.

Mumbai: Pharma major Glenmark Pharma said that Glenmark Pharmaceuticals Inc., US has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Hydrocortisone Valerate Ointment USP, 0.2 pc, a generic version of Westcort Ointment, 0.2 pc, of Sun Pharmaceutical Industries, Inc.

The company has been granted a competitive generic therapy (CGT) designation for Hydrocortisone Valerate Ointment USP, 0.2 pc, therefore, with this approval, Glenmark is eligible for 180 days of CGT exclusivity upon commercialisation, Glenmark said in a filing with BSE.

This medication is used to treat a variety of skin conditions such as eczema, dermatitis, allergies, rash. Hydrocortisone valerate reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a medium-strength corticosteroid.

This is Glenmark's first granted CGT product approved by the FDA.

Glenmark Pharmaceuticals is a pharmaceutical company headquartered in Mumbai, India that was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer. The company went public in India in 1999 and used some of the proceeds to build its first research facility.

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