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Wednesday, Apr 20, 2005

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Matrix unit gets USFDA nod

Our Bureau

HYDERABAD: Matrix Laboratories Ltd has received the US FDA approval for its active pharmaceutical ingredients (APIs) manufacturing facility at Kazipally (Unit-II), near here. Commissioned in 2004, the facility currently manufactures anti-retrovirals (ARVs) for the treatment of HIV/AIDS.

In a press release here on Tuesday, the company said the approval would enable it to supply to the US President, Mr George Bush's $15-billion PEPFAR (The President's Emergency Plan for AIDS Relief) programme, besides other regulated markets.

With this, the company has four US FDA-approved facilities, making it one of the largest API manufacturing capacities in India to meet the regulatory market requirements. The company has filed 46 drug master files with US FDA as of March 2005.

Commenting on the development, the Matrix Chairman and CEO, Mr N. Prasad, said, "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."

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