UK regulator withdraws certification of Wockhardt unit

Oct 13 2013, 03:47 IST
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SummaryUK’s health regulator has withdrawn the good manufacturing certification of the company’s Chikalthana facility in Maharashtra

In yet another setback to drug firm Wockhardt, UK’s health regulator has withdrawn the good manufacturing certification of the company’s Chikalthana facility in Maharashtra.

“The company has received a communication from the Medicines and Healthcare Products Regulatory Agency, United Kingdom (UKMHRA), whereby the agency has decided to withdraw the previously issued GMP (good manufacturing practice) certificate to the company’s manufacturing facility at Chikalthana, Aurangabad," Wockhardt said in a filing to the BSE.

MHRA has also said it “will be issuing a restricted GMP certificate to the site, along with a statement of non-compliance for the said site", it added. The impact of this move on existing business will only be known once the company receives further communication from UKMHRA, Wockhardt said.

The said facility contributes approximately 12 million pounds from the UK and EU markets to the consolidated annual revenues of the company, it added.

However, the scope of the statement of non-compliance is limited to medicinal products considered non-critical to public health, so the company shall be able to manufacture and supply from the said facility certain products critical to public health, it added.

Earlier in July this year, UKMHRA had imposed an import alert on Wockhardt’s plant at Waluj in Maharashtra and issued a precautionary recall for 16 medicines made at the unit.

In May, US Food and Drug Administration had also issued an import alert on the same facility. Wockhardt had said it had initiated corrective actions to resolve issues at the Waluj plant.

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