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UKMHRA withdraws GMP certificate for Wockhardt's plant

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Pharma major Wockhardt has said that it 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 Certificate to the Company's manufacturing facility in Daman and will be issuing a restricted GMP Certificate to the site along with a statement of noncompliance for the said site.

"In order to avoid market shortage of medically essential products, the GMP certificate will be conditioned to permit continued manufacturing and QC testing of 'critical' products in situations where it has been agreed by the national competent authority or EMA (as appropriate) that there is no feasible alternative in the market concerned. The scope of the statement of non-compliance is therefore limited to medicinal products considered noncritical to public health," Wockhardt has said in a release to the exchanges.

 

Accordingly, the Company shall be able to manufacture and supply from the said facility certain medicinal products critical to public health.

The impact of the same on existing business will only be known once the Company receives further communication from UKMHRA.

Wockhardt does not manufacture any products for the US market at the said manufacturing facility.

The shares of Wockhardt were down more then 2% on the National Stock Exchange.

GoodReturns.in

Read more about: wockhardt
Story first published: Tuesday, October 22, 2013, 12:58 [IST]
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