UK’s drug regulator has revoked the quality compliance certificate of Mumbai-based Wockhardt Ltd’s factory located in Nani Daman, making it the third plant of the company to come under scrutiny.
In place of Good Manufacturing Practice (GMP) certification, UK Medicines and Healthcare Products Regulatory Agency (UKMHRA) has issued the factory with a restrictive GMP to the site. This was done to avoid market shortage of medically essential products, the company said in a filing in the stock exchange on Tuesday.
“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 company said.
The company would be manufacturing products considered critical to public health. Wockhardt does not manufacture any products for US market at this facility, the it added.
This is the third facility of Wockhardt to come under scrutiny. Earlier this month, UK regulatory authorities took away company’s GMP certificate for its Chikalthana (Aurangabad) facility. This was followed by US FDA banning products from the company’s facility in Waluj (near Aurangabad) due to hygiene and compliance deficiencies.
Last week, MHRA recalled five of the company’s drugs from the UK market even as it allowed the company to make 10 others in public interest. Wockhardt has seven plants in India.
The full extent of this decision on existing businesses will be known once Wockhardt receives further communication from MHRA, the company said in the filing.
Wockhardt’s stock price, which opened at Rs 480 on Tuesday, dropped by over 4 per cent and closed at Rs 458.
(Edited by Joby Puthuparampil Johnson) Leave Your Comment