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Wockhardt’s U.S. Unit Gets Warning Letter From Drug Regulator

Wockhardt has already initiated measures to address issues raised by the U.S. FDA.



Drugs produced by Wockhardt (Photographer: Dhiraj Singh/Bloomberg)
Drugs produced by Wockhardt (Photographer: Dhiraj Singh/Bloomberg)

Mumbai-based pharmaceutical company Wockhardt Ltd. on Wednesday said that its U.S. subsidiary Morton Grove Pharmaceuticals Inc. has received a warning letter from the drug regulator.

New drug approvals will be withheld till the issues are resolved, the company said in a stock exchange filing. The warning letter will not affect the availability of the current product portfolio in the market, it added.

Wockhardt has already initiated appropriate measures to address the issues raised by the U.S. Food and Drug Administration with the help of consultants, the filing said.