- The India-based company had said it was addressing FDA issues
- Ban affects drug products Wockhardt makes in Ankleshwar, India
Wockhardt Ltd. plunged the most in six months after its third drug-manufacturing plant in India was banned by the Food and Drug Administration from importing products into the U.S.
The FDA said in an alert posted Friday that it had banned all drugs and drug products made by the factory, based in Ankleshwar, India. The plant makes bulk ingredients according to Wockhardt’s annual report. The agency recently inspected the Ankleshwar facility and three others, the company said in the report, and Wockhardt had responded to those findings.
Wockhardt plunged as much as 14 percent Monday. The stock closed 10 percent lower at 915.05 rupees.
Details of the FDA’s observations haven’t been made public, and Lyndsay Meyer, a spokeswoman for the agency, said by phone that the FDA doesn’t publicly disclose such details. Wockhardt in a statement said it has "already initiated required steps to address the concerns raised" by the FDA and is making an effort to resolve the matter.
The FDA banned two other Wockhardt factories in 2013, including one that made copies of a popular heart pill, Toprol-XL. The Ankleshwar plant is one of 44 facilities on FDA’s list of banned manufacturing factories in India, most of which are the result of stepped-up enforcement by the agency as the U.S. relies more on producers there and in China for generic drugs and ingredients.