UK withdraws certification to Wockhardt

By Marc Castro

Oct 12, 2013 11:25 PM EDT

Wockhardt, the pharmaceutical firm, suffered another setback as the UK health regulator withdrew its certification for good manufacturing. This certification covers the company's Chikalthana facility located in the Maharashtra India.

According to company documents filed with the Bombay Stock Exchange, "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 Certificate to the company's manufacturing facility situated at L1, MIDC, Chikalthana, Aurangabad."

The MHRA communique added that it would issuing 'a restricted GMP (good manufacturing practice) Certificate to the site alongside with a statement of non-compliance for the said site."

Wockhardt said the facility provides nearly GBP12 million from the UK and EU markets as consolidated annual revenues of the firm. It added, "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 to the market concerned."

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