Glenmark gets USFDA approval for generic joint-pain drug in US

Glenmark Pharmaceuticals said it received final approval from the United States Food & Drug Administration for marketing a generic version of joint-pain drug Indocin of Iroko Pharmaceuticals.

The drug has annual sales of approximately $6.3 million.

With this, Glenmark’s portfolio has expanded to 118 products authorized for distribution in the U.S. and 67 pending approvals 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,” the company said.

Glenmark is primarily 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 and has 17 manufacturing facilities across five countries and has six R&D centers.

The Generics business of Glenmark mainly serves the US and Western European markets, while the active pharmaceutical ingredients business sells its products in over 80 countries.