Matrix facility gets US FDA approval

Matrix Laboratories Limited has received US FDA approval for its manufacturing facility located at Jeedimetla on the outskirts of the city.

The site approval accorded by the US FDA will enable the company to manufacture several active pharmaceutical ingredients (APIs) from this facility to the US market.

With Citalopram API manufactured from this facility, the approval will enable the company to launch Citalopram API in the US market as per schedule.

This is the second US FDA approved facility for Matrix, the first one being the unit located at Pashamylaram. The company has already been exporting products manufactured at Pashamylaram facility to the US market.

The latest approval has come at a time when the company is aggressively expanding its presence in the US. Matrix has filed 12 drug master files (DMFs) with the US FDA as on December 31, 2003, besides some more DMFs being filed in the current quarter.

"The approval from the US FDA will give us the comfort in meeting the capacity requirements of our US customers without any time constraints. This assumes significance with many products in the anvil for the US market," N Prasad, chairman and CEO of Matrix, said in a press release.

Matrix has invested around Rs 40 crore at another unit located at Kazipally near Hyderabad to make it US FDA compliant. This facility will be commissioned in a month's time and is expected to go for US FDA inspection in the next fiscal.