Wockhardt caught in FDA turmoil again

Somehow, Wockhardt and the US FDA never seem to get off on the right footing. One after the other, the FDA issues keep on cropping up,.

This time around, as alerted by the company yesterday after market hours, it is for its stepdown subsidiary, Morton Grove Pharmaceuticals Inc., USA.

The FDA has issued a warning letter to Morton. This means that the current portfolio of the company will continue to be made available in the market. However, new approvals will be withheld till resolution. The company, with the help of the Consultants, has already initiated appropriate measures since last several months to address the issues raised by USFDA.

The company’s three plants at Chikhalthana and Waluj in Aurangabad and Ankleshwar are already facing import alerts against them. It currently exports from its Chikhalthana plant to the US and it was Morton Grove which was taking care of the US market. With this warning letter, the company will not be able to get approvals for any product filed from Morton.