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Matrix Labs Bags USFDA Approval

The Economics Times-12th March, 2004

MATRIX Laboratories has received USFDA approval for its manufacturing facility at Jeedimetla near Hyderabad. This would enable the company to roll out active pharmaceutical ingredients (APIs) from its facility to the US markets.

The approval will also help Matrix to launch its key product Citalopram, currently being supplied to European markets, in the US shortly. This is the second USFDA approved facility for Matrix, the first being the unit located at Pashamylaram, near Hyderabad. The FDA approval has come at a time when Matrix is aggressively expanding its presence in the US markets, according to the company's press release issued here on Thursday. Matrix has filed 12 Drug Master Files (DMFs) with USFDA as on December 2003.

The company plans to file a significant number of DMFs with USFDA during the next financial year, the release said. Matrix has a large customer base of generic manufacturers in the US, besides having a significant presence in Europe. Some of the company's products are currently undergoing validation trials for US markets. The company's unit at Kazipally, near Hyderabad, will also undergo USFDA inspection during the next fiscal year, the release added. Matrix has invested Rs.40 crore at its Kazipally unit for making it USFDA compliant.


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