Mumbai: Drug maker Wockhardt Ltd said the US 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 US business.
In a so-called 'Form 483' issued to the company after a recent inspection of the plant, the US health regulator 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 per cent, 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 US regulator.
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 per cent 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.
Shares in Wockhardt, on Friday, ended 14.98 per cent lower at Rs 1,288.40 apiece on the BSE, whose benchmark Sensex index finished down 1.28 per cent.
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