UK health regulator says no to Wockhardt unit
Drug firm Wockhardt on Tuesday said the UK health regulator has withdrawn good manufacturing certificate of its manufacturing unit at Kadaiya in Nani Daman, the second such instance in as many weeks.business Updated: Oct 22, 2013 14:39 IST
Drug firm Wockhardt on Tuesday said the UK health regulator has withdrawn good manufacturing certificate of its manufacturing unit at Kadaiya in Nani Daman, the second such instance in as many weeks.
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 Kadaiya, Nani Daman, Wockhardt said in a filing to the BSE.
The UKMHRA will be issuing a restricted GMP certificate to the site along with a statement of non-compliance for the said site, the filing added.
Wockhardt, however, said "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".
Accordingly, the company shall be able to manufacture and supply from the said facility certain medicinal products critical to public health, Wockhardt said.
"The scope of the statement of non-compliance is therefore limited to medicinal products considered non-critical to public health," it added.
The impact of the same on existing business will only be known once the company receives further communication from UKMHRA, Wockhardt said.
The company doesn't manufacture any products for the US market at the Kadaiya unit, it added.
Shares of Wockhardt were today trading at Rs 468.25 per scrip in the afternoon trade on BSE, down 2.19 per cent from its previous close.
Last week, the company had made a similar filing stating UK's health regulator had withdrawn the good manufacturing certification of the company's Chikalthana facility in Maharashtra.
Earlier in July this year, UKMHRA 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, US Food and Drug Administration (USFDA) had also issued an import alert on the same facility which makes injectables and solid dosages.
Wockhardt had at that time said it had already initiated several corrective actions to resolve the issues at the Waluj plant.