In yet another setback to drug firm Wockhardt, UK’s health regulator has withdrawn the good manufacturing certification of the company’s Chikalthana facility near Aurangabad in Maharashtra.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 Certificate to the company’s manufacturing facility situated at L1, MIDC, Chikalthana, Aurangabad,” Wockhardt said in a filing to the Bombay Stock Exchange.
The UKMHRA has also said it “will be issuing a restricted GMP (good manufacturing practice) Certificate to the site along with a statement of non-compliance for the said site”, it added.
The impact of the action on existing business will only be known once the company receives further communication from UKMHRA, Wockhardt said. The Chikalthana facility contributes approximately £12 million to the consolidated annual revenues of the company.
The comany filing said that the GMP certificate would be “conditioned to permit” the manufacture of critical products in cases where no feasible alternative is available in the market as certified by the competent authority.
The filing added that the scope of the statement of non-compliance is limited to medicinal products considered non-critical to public health.