Glenmark Pharmaceuticals receives ANDA approval for Azelaic Acid Gel

Published On: November 20th 2018 at 9:11 AM

glenmark pharmaceuticals ltdGlenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Azelaic Acid Gel, 15%, a generic version of Finacea®1Gel, 15%, of Leo Pharma A/S.

According to IQVIATM sales data for the 12 month period ending September 2018, the Finacea® Gel, 15% market achieved annual sales of approximately $64.1 million*.

Glenmark’s current portfolio consists of 143 products authorized for distribution in the U.S. marketplace and 56 ANDA’s pending approval with the U.S. FDA. 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.

About Glenmark Pharmaceuticals


Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization. It is ranked among the top 75 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2018). 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.