Matrix Labs gets US approval for second unit

By Our Corporate Bureau | 13 Mar 2004

1
Hyderabad: Matrix Laboratories Ltd (MLL), the Hyderabad-based active pharmaceutical ingredients (APIs) company, has received the United States Food and Drug Administration (USFDA) approval for its manufacturing facility located at Jeedimetla near Hyderabad.

The company expects the approval would enable it manufacture several APIs from this facility to the US market. The approval would enable the company launch Citalopram API, a big earner in the US market as per schedule, MLL said in a press release. The Jeedimetla facility is the second unit to obtain FDA approval after Pashamylaram near here. MLL has been exporting products manufactured at Pashamylaram facility to the US market.

According to MLL, the latest approval has come at a time when it was expanding its presence in the US market. As at the end of December 2003, the company has filed 12 drug master files (DMFs) with the FDA. The company plans to file some more DMFs during the current quarter.

Commenting on the development, the MLL Chairman and Chief Executive Officer, Mr N. Prasad, said, "The FDA approval will give us the comfort in meeting the capacity requirements of our US customers without any time constraint. This assumes significance with many products on the anvil for the US market."

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