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India's Wockhardt to appoint consultant at plant for US FDA compliance
July 25, 2013 / 6:11 AM / 4 years ago

India's Wockhardt to appoint consultant at plant for US FDA compliance

MUMBAI, July 25 (Reuters) - India’s Wockhardt has initiated a process to appoint a U.S.-based consultant at its western India drug factory, its managing director said, after the U.S. drug regulator issued a warning letter to the factory over quality compliance issues.

“The consultant has extensive experience and expertise in CGMP (current good manufacturing practices) and will work with the Wockhardt team to address issues raised by the U.S. F.D.A,” Managing Director Murtaza Khorakiwala said in a statement on Thursday.

Shares in Wockhardt plummeted as much as 20 percent on Wednesday after brokerage Macquarie downgraded the stock on concerns that an import ban imposed by the United States over quality issues would last longer than expected.

In its warning letter dated July 18, the U.S. Food and Drug Administration said it may withhold approvals for any new launches Wockhardt was planning for the United States until the company addressed its concerns about the Waluj plant.

Wockhardt has previously said the U.S. ban would cost the company about $100 million in sales a year. The manufacturing plant has also been banned from exporting products to the UK due to similar reasons.

The stock was down 6.8 percent at 614.50 rupees by 0605 GMT compared with a 0.26 drop in the benchmark Mumbai market .

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