Wockhardt Barred From Making Drugs for Europe, U.K. Agency SaysKetaki Gokhale
Wockhardt Ltd., an Indian maker of insulin and hepatitis vaccines, was barred from making drugs for Europe after its Waluj factory failed to meet some guidelines from the U.K. regulator.
The U.K.’s Medicines and Healthcare Products Regulatory Agency is working with Wockhardt, the U.S. Food and Drug Administration and other international regulators to help resolve the issues so production can resume, the U.K. agency said in an e-mail yesterday. The statement of non-compliance for the plant covers medicines to Europe and the U.K., it said.
The ban adds to restrictions on exports by Wockhardt after U.S. regulators in May barred drugs from the same factory, a move that Chairman Habil Khorakiwala said would cut about $100 million from the company’s revenue in the year started April 1. The U.K. agency first announced July 5 that Wockhardt’s Waluj plant didn’t meet some manufacturing guidelines.
Daryl Suchitha, a spokesman for Wockhardt, didn’t immediately respond to an e-mail and a phone call to his office seeking comment today.
Wockhardt rose 1.3 percent to 925 rupees as of 9:44 a.m. in Mumbai trading, paring its loss to 41 percent this year. India’s benchmark Sensitive index was little changed today.
Europe contributed 28 percent of Wockhardt’s 46 billion rupees ($765 million) revenue in the 12 months ended March 31, 2012, according to the Mumbai-based drugmaker’s annual report.
Khorakiwala on July 5 addressed only the impact of the agency’s restrictions on the U.K. market. “The products will be available to be shipped from alternative sites, thereby having negligible impact on the financials,” he said in a statement that day.