Wockhardt said on Tuesday that UK drug regulator Medicines and Healthcare products Regulatory Agency (MHRA) has decided to withdraw the GMP (Good Manufacturing Practice) certificate previously issued to its facility in Kadaiya, Nani Daman.
MHRA will issue a “restricted GMP certificate” to the site along with a statement of non-compliance, the company said in a note to stock exchanges.
Critical drugs allowed
However, Wockhardt said the UK regulator has indicated that the GMP certificate would permit continued manufacturing and quality control testing of ‘critical’ products, in situations where it has been agreed by the national competent authority or European Medicines Agency (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, Wockhardt said, adding that it would be able to manufacture and supply certain products critical to public health from the facility.
The impact of the development would be known once the company received further communications from the UK regulator, the company said.
Wockhardt does not manufacture any products for the US market at the Daman facility, it added.
Currently, two other Wockhardt facilities — in Chikalthana (Aurangabad) and Waluj (near Aurangabad) — are under US and UK regulatory scrutiny.
Wockhardt shares closed at Rs 458, down over four per cent, on the Bombay Stock Exchange, on Tuesday.