UK regulator takes back Wockhardt unit certificate

In yet another setback to drug maker Wockhardt, the UK's health regulator has withdrawn the good manufacturing certification of the company's Chikalthana facility in Maharashtra.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

The agency 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 this on business will only be known once the company receives further communication from the agency, Wockhardt said.

The facility contributes about £12 million from the UK and EU to the consolidated annual revenues of the company, 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 in the market concerned," Wockhardt said.

The scope of the statement of non-compliance is therefore limited to medicinal products considered non-critical to public health.

Accordingly, 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, the agency had imposed an import alert on Wockhardt's export-oriented plant at Waluj in Maharashtra and issued a precautionary recall for sixteen medicines made by the company at the unit.

In May, the US Food and Drug Administration had also issued an import alert on the same facility which makes injectables and solid dosages.

Wockhardt had said it had already initiated several corrective actions to resolve the issues at the Waluj plant.