UKMHRA withdraws GMP Certificate issued to Wockhardt’s Aurangabad manufacturing facility

Wockhardt Ltd has informed BSE that 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 and will be issuing a restricted GMP Certificate to the site along with a statement of non-compliance for the said site.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. Accordingly, the Company shall be able to manufacture and supply from the said facility certain medicinal products critical to public health.The impact of the same on existing business will only be known once the Company receives further communication from UKMHRA. The said facility contributes approximately 12 million £ from the UK and EU markets to the consolidated annual revenues of the Company.Source : BSE

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