Mumbai: 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 UK regulator.
The UK’s Medicines and Healthcare Products Regulatory Agency is working with Wockhardt, the US Food and Drug Administration and other international regulators to help resolve the issues so production can resume, the UK agency said in an e-mail on Tuesday. The statement of non-compliance for the plant covers medicines to Europe and the UK, it said.
The ban adds to restrictions on exports by Wockhardt after US 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 1 April. The UK agency first announced on 5 July 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 on Wednesday.
Wockhardt rose 3.91% to Rs.949.90 as of 11.44am in Mumbai trading on Wednesday. India’s benchmark Sensex was little changed.
Europe contributed 28% of Wockhardt’s Rs.4600 crore revenue in the 12 months ended 31 March 2012 according to the Mumbai-based drugmaker’s annual report.
Khorakiwala on 5 July addressed only the impact of the agency’s restrictions on the UK 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. BLOOMBERG