Wockhardt Ltd has told BSE the company has received a communication from the UK Medicines and Healthcare Products Regulatory Agency (UKMHRA), informing it of withdrawing the previously issued good manufacturing practice (GMP) certificate to the company's manufacturing facility situated at L1, MIDC, Chikalthana, Aurangabad. It will issue a restricted GMP certificate to the site along with a statement of non-compliance.
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 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 would be able to manufacture and supply from the said facility certain medicinal products critical to public health. The impact of the same on the 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 European Union markets to the consolidated annual revenues of the company.
