Problems for Wockhardt, generic drug maker, just don't seem to end. In another blow to the company, United Kingdom's health regulator has withdrawn the good manufacturing certification of the company's Chikalthana facility in Maharashtra.
As per a statement released by Wockhardt, “The company has received a communication from the Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom, whereby the agency has decided to withdraw the previously issued good manufacturing practice (GMP) certificate to the company's manufacturing facility situated at l1, MIDC, Chikalthana, Aurangabad.”
MHRA has also said it “will be issuing a restricted GMP Certificate to the site along with a statement of non-compliance for the said site,” 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 said facility contributes approximately GBP 12 million from the UK and EU markets 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.