The Hindu Business Line : Matrix Labs gets US nod for second unit

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

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.

The company said 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."

Matrix Labs said it has invested about Rs 40 crore at another unit located at Kazipally near here to make the facility USFDA compliant. The company expects this facility to be commissioned in a month's time and go for USFDA inspection during the next fiscal, the release said.

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