Pharmaceutical company Wockhardt on Tuesday said in a regulatory filing that the UK health regulator has withdrawn a good manufacturing practices (GMP) certificate given to the company’s Kadaiya production unit in Nani Daman.
However, the Medicines and Healthcare Products Regulatory Agency, United Kingdom (UKMHRA) will allow the Mumbai-based company to continue manufacturing some critical drugs, as there is no feasible alternative available in the market.
Wockhardt said the impact of the imposition of a “restricted” GMP certificate will be known when it receives further communication from the UKMHRA.
“In order to avoid market shortage of medically essential products, the GMP certificate will be conditioned to permit continued manufacturing and QC (quality control) 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 Kadaiya facility is located in the union territory of Daman & Diu and was established in 1998. It covers 6,530 square metres or about 1.6 acres and had the UKMHRA nod to manufacture high potent solid dose forms. It does not manufacture any products for the US market.
This is the third Wockhardt production facility in which the UKMHRA has identified issues this year.
The Chikalthana facility also faced a similar action earlier this month after the UKMHRA identified a number of manufacturing issues that breach GMP rules. This action occurred nearly three months after the regulator recalled 16 drugs manufactured at the facility on a precautionary basis for the same reason.
Wockhardt’s Waluj plant is already facing an “import alert” imposed by the US Food and Drug Administration. The alert preempts any Wockhardt products manufactured at the facility from entering the American markets. Since then, Wockhardt shares have lost 63% of its value.
On a financial basis, the company had said the Waluj facility would adversely impact its revenue to the tune of $100 million on an annual basis while the UKMHRA recall of drugs made at Chikalthana will create a one-time charge of about 1 million pounds. Both figures add up to R626 crore according to today’s