UK regulator withdraws GMP Certificate of Wockhardt’s Aurangabad manufacturing facility

14 Oct 2013 Evaluate

Wockhardt 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.

Wockhardt Share Price

1477.30 16.15 (1.11%)
27-Dec-2024 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1861.70
Dr. Reddys Lab 1389.35
Cipla 1506.15
Lupin 2228.00
Zydus Lifesciences 972.70
View more..
© 2024 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.