UK regulator to withdraw approval for Wockhardt's Daman plant

GMP certification for Wockhardt's Chikaltahana plant was also withdrawn 2 weeks ago

In another setback for pharma major Wockhardt, medical regulator UK MHRA has decided to withdraw Good Manufacturing Practices (GMP) certification for company's plant at Daman.

This is the third plant to be hit by export restrictions this year.

Two weeks ago, GMP certification for Wockhardt's Chikaltahana plant was withdrawn by UK MHRA.

The UK regulator's measures followed a ban by the US Food and Drug Administration on drug shipments to the United States from a separate Wockhardt factory in Waluj, after hygiene and other compliance deficiencies were found. The UK agency later recalled products made at the Waluj plant.

"The company 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 Nani Daman and will be issuing a restricted GMP Certificate to the site along with a statement of noncompliance for the said site," a BSE statement from Wockhardt said.

According to company, impact of the same on existing business will only be known once the company receives further communication from UK MHRA.

Shares of the company went down to Rs 458 from the opening price of Rs 480. Shares are currently trading at Rs 464 on the BSE.

The company doesn't manufacture any products for the US market at the said manufacturing facility, it added.