(Reuters) - Britain's drug regulator revoked the quality compliance certificate for a Wockhardt Ltd WCKH.NS factory in India, the drugmaker said on Tuesday, the third of its plants to be hit by export restrictions this year.
The UK Medicines and Healthcare Products Regulatory Agency will instead issue a restricted certificate, which means Wockhardt will be able to supply only “critical” products from the factory located in Kadaiya in western India, the company said in a statement.
Earlier this month, the UK regulator took away the generic drugmaker’s good manufacturing practice (GMP) certificate for its key Chikalthana factory. [ID:nL3N0I40RQ] Last week, the UK regulator issued a recall for drugs made at the plant.
The UK regulator’s measures followed a ban by the U.S. 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.
Wockhardt, which has seven plants in India, said on Tuesday the impact of the MHRA’s decision on existing business will only be known once it receives further communication.
The company's shares were down as much as 4 percent after it issued the statement before paring some losses to trade down 2 percent at 468.35 rupees. The main index .BSESN was trading down 0.2 percent. Its shares have lost nearly 80 percent since their record-high in March.
Reporting by Aradhana Aravindan; Editing by Tony Munroe and Matt Driskill
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