MUMBAI (Reuters) - Indian drugmaker Wockhardt Ltd said the U.S. Food and Drug Administration (FDA) had issued a notice outlining manufacturing violations at its Shendra plant in western India, delaying the company’s plans to rebuild its battered U.S. business.
In a so-called ‘Form 483’ issued to the company after a recent inspection of the plant, the FDA listed nine concerns that Wockhardt said it would respond to in “due course.”
It did not disclose what the FDA’s concerns were, and a company spokesman did not respond to requests for comment through the day.
Wockhardt built the Shendra plant, which it claims is “a first of its kind in Asia,” to make difficult-to-manufacture injectable products, and has been banking on it to reconstruct its business in the world’s largest healthcare market.
The United States once contributed a majority of Wockhardt’s revenue, but now makes up only about 19 percent, as the FDA banned imports from two of its key drug plants over manufacturing quality concerns over the last three years. Those plants are yet to be cleared by the FDA.
Dozens of drug manufacturing plants in India have been banned or cited for violations of standards by the FDA in the past three years as the agency improved inspections of foreign drug plants. India supplies about 40 percent of the generic and over-the-counter medicines sold in the United States.
There are several steps between the issuing of a Form 483 and the banning of a manufacturing plant.
Wockhardt’s stock slumped about 17 percent to its lowest in four months on Friday, after the Indian television news channel ET Now first reported the FDA notice. By the time Wockhardt issued a statement, the stock had closed down 15 percent.
Reporting by Zeba Siddiqui; Editing by Mark Potter
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