US FDA approval for Kazipally facility
Hyderabad, April 19, 2005.
Matrix Laboratories Limited has received US FDA approval for its Active Pharmaceutical Ingredients (APIs) manufacturing facility located at Kazipally (Unit-II), near Hyderabad. Commissioned in 2004, the facility currently manufactures anti-retrovirals (ARVs) for the treatment of HIV/AIDS.
The approval will enable the company to supply ARV APIs to the President Bush's $ 15-billion PEPFAR (The President's Emergency Plan for AIDS Relief) programme, besides other regulated markets.
With the latest approval, the number of US FDA-approved facilities of the company would be four, thus making it as one of the largest API manufacturing capacities in India to meet the regulatory market requirements. The company has filed cumulative 46 Drug Master Files (DMFs) with US FDA as of March 2005.
"The US FDA approval has come at a time when the company is taking several strategic initiatives to serve its customers better. This will enable Matrix to establish its position as a leading supplier of ARVs to the global market", said N Prasad, the Chairman & CEO of Matrix.
|