Indian drugmaker Wockhardt is dealing with more fallout tied to manufacturing lapses at one of its plants in its home country. The generic drugmaker said that a U.K. regulator has issued an import alert for the plant 6 weeks after the FDA banned products from the facility from being shipped to the U.S.
Wockhardt announced in India Friday that the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued the import alert on a unit of a plant at Waluj in Maharashtra, BusinessToday reported. Wockhardt Chairman Habil Khorakiwala said the company would shift manufacturing from the Waluj plant to another facility to minimize the financial fallout. He said the same thing in May when the FDA put the plant on its watch list, but he acknowledged at the time that the U.S. alert could cost it up to $100 million.
In April, the company issued a statement on its website that the FDA had issued a Form 483 for problems it observed at the solid-dose and sterile-injectables plant. Wockhardt said it had initiated an accelerated and comprehensive remedial measure and was committed to achieving full compliance in the shortest period of time.
An import ban is a costly measure because it keeps a company from using a plant for new drug launches in addition to restricting exports of whatever products it already makes at the facility. Canada's generic drugmaker Apotex is even seeking damages before international mediators, claiming that a two-year import ban the FDA issued against it "decimated" its business. Its claim says the ban cost it more than $520 million. It has argued that the ban, which was lifted in 2011, violated the North American Free Trade Agreement.
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