Glenmark Generics’ (GGL) United States (US) subsidiary -- Glenmark Generics Inc., (GGI) -- has been granted final approval for its Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (USFDA) for Ursodiol tablets USP, their generic version of Urso 250 and Urso Forte tablets by Axcan.
Ursodiol tablets are available in 250mg and 500mg strengths and are indicated for the treatment of patients with primary biliary cirrhosis (PBC). Total market sales achieved for the Ursodiol tablets were $60 million.
Glenmark’s current portfolio consists of 70 products authorized for distribution in the US marketplace and 40 ANDA’s pending approval with the USFDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.
GGL is a subsidiary of Glenmark Pharmaceuticals and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, EU and Argentina and maintains marketing front-ends in these countries.
