Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd, (GGL) announced they have been granted final approval for their Abbreviated New Drug Application (ANDA) by the United States Food and Drug Administration (US FDA) for Ursodiol tablets USP, their generic version of Urso 250 and Urso Forte tablets by Axcan.
Ursodiol tablets are available in 250 mg and 500 mg strengths and are indicated for the treatment of patients with Primary Biliary Cirrhosis (PBC). According to IMS Health for the 12 month period ending March 2011, total market sales achieved for Ursodiol tablets were US$ 60 million. Shipping will commence immediately from Glenmark’s New Jersey facility.
The company’s current portfolio consists of 70 generic products authorized for distribution in the US market and approximately 40 ANDA’s filed with the US FDA pending approval. 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 Limited (Glenmark) and aims to be a global integrated Generic and API leader.