Shares of Wockhardt today dropped 5% after UK’s medicines regulator withdrew its certification to its unit, which generated annual revenues of GBP 12 million (about Rs 117 crore).
"The UK’s Medicines and Healthcare Products Regulatory Agency (UKMHRA)…has decided to withdraw the previously issued GMP Certificate to the company’s manufacturing facility situated at L1, MIDC, Chikalthana, Aurangabad and will be issuing a restricted GMP Certificate to the site along with a statement of non-compliance for the said site,” Wockhardt said in a BSE filing on Friday.
“The facility contributes approximately GBP 12 million from the UK and EU markets to the consolidated annual revenues of the company,” it added.
Shares of the company hit its 5% lower limit to Rs 499.3 on BSE in the opening trade.
Wockhardt said it will continue to manufacture certain products ‘critical to public health’ and the exact impact on the business can be assessed after its receives further communication from UKMHRA.
“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 non-critical to public health,” the company said.
"The UK’s Medicines and Healthcare Products Regulatory Agency (UKMHRA)…has decided to withdraw the previously issued GMP Certificate to the company’s manufacturing facility situated at L1, MIDC, Chikalthana, Aurangabad and will be issuing a restricted GMP Certificate to the site along with a statement of non-compliance for the said site,” Wockhardt said in a BSE filing on Friday.
“The facility contributes approximately GBP 12 million from the UK and EU markets to the consolidated annual revenues of the company,” it added.
Shares of the company hit its 5% lower limit to Rs 499.3 on BSE in the opening trade.
Wockhardt said it will continue to manufacture certain products ‘critical to public health’ and the exact impact on the business can be assessed after its receives further communication from UKMHRA.
“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 non-critical to public health,” the company said.