Glenmark Pharmaceuticals receives ANDA approval for Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil)

Deepthi | Myequity news | Date : 26-10-2018 10:25:00 IST

Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration for Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil), a generic version of Derma-Smoothe/FS® Topical Oil, 0.01% (Body Oil), of Hill Dermaceuticals, Inc.

According to IQVIATM sales data for the 12 month period ending August 2018, the Derma- Smoothe/FS® Topical Oil, 0.01% market achieved annual sales of approximately $14.5 million.

About Glenmark Pharmaceuticals:

Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization. Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is focused in the areas of oncology, dermatology and respiratory. The company has a significant presence in the branded generics markets across emerging economies including India. Glenmark has 16 manufacturing facilities across five countries and has six R&D centers. The Generics business of Glenmark services the requirements of the US and Western European markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India.


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