Mylan says FDA approves its drug production

Generic and pharmaceutical products maker Mylan Laboratories today said that the US Food and Drug Administration (FDA) had scrutinised its production facilities at Morgantown and found baseless the recent allegations against the company's production quality.

The Pittsburgh Post-Gazette had published a report on Sunday alleging the company workers had ignored warnings related to potential problems during drug production at its Morgantown facility.

Mylan on the same day disputed the allegations as being false.

According to reports, the FDA clarified that the minor standard operating procedures deviation had been corrected by Mylan,

Mylan chairman and CEO Robert J Coury said, "I want to first thank the FDA for responding as quickly as it did in light of the seriousness of these unfounded accusations. I hope that these actions only reaffirm Mylan's long-standing reputation as one of the industry's highest quality manufacturers with a management team that has an unyielding commitment to adhere to the highest quality standards."

However, Steven Solomon, the FDA assistant commissioner for compliance policy, was reported as saying, ''The investigation is ongoing and the agency has formed no conclusions at this time."

Mylan provides products to customers in more than 140 countries and territories, and ranks among the leading diversified generic and specialty pharmaceutical companies in the world.

In January 2007, Mylan Laboratories completed the acquisition of approximately 51.5 per cent of Matrix's outstanding shares for Rs306 per share in cash pursuant to a share purchase agreement (SPA) with certain selling shareholders. (See: Mylan completes stake acquisition in Matrix)