Glenmark launches `Azathioprine' tablets in US
20 Nov 2008
Glenmark Generics Ltd, the US subsidiary of Glenmark Pharmaceuticals Ltd, has received US FDA approval for distributing its Azathioprine 50mg tablets in the United States.
Azathioprine is the generic equivalent of `Imuran' tablets and is indicated as an adjunct for the prevention of rejection in renal homo-transplantations (kidney transplantation). It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms.
Azathioprine had total sales of approximately $36 million for the 12-month period ended June 2008, according to IMS Health.
Glenmark said it is committed to enhance and augment its current portfolio of internal filings through the addition of external partnerships.
Glenmark said it has been authorised to distribute 130 SKUs in the US market. The company currently has 40 ANDAs in various stages of approval with US FDA.
Glenmark Generics Limited has an established presence in North America, the EU and Argentina and maintains marketing front-ends in these countries.
Glenmark has a state-of-the-art manufacturing plant at Goa that is approved by US FDA, TPD (Canada), MHRA, UK and many other overseas regulatory authorities. GGL also markets over 45 APIs to more than 80 countries across the world.
and had over 30 USDMFs filed and/or approved along with several Canadian DMFs, EDMFs and CEPs/CoSs, the company said in a release.