Wockhardt Ltd. fell the most in more than three weeks in Mumbai trading after the company said the U.K. drugs regulator withdrew a certificate entitling one of its plants to export drugs to the nation.
Wockhardt dropped as much 5.1 percent, poised for the biggest decline since Sept. 17. The stock traded down 5 percent at 499.65 rupees as of 10:43 a.m. in Mumbai. A factory needs the so-called good manufacturing practice, or GMP, certification to supply medicines to the U.K.
The Medicines and Healthcare Products Regulatory Agency’s action marks the second instance of a western drug regulator citing problems in the factory in Chikalthana, about 220 miles (354 kilometers) east of Mumbai. The plant sells about 12 million pounds ($19 million) of medicines annually to the U.K and the European Union, and Wockhardt is awaiting more information from the regulator, the drugmaker said Oct. 12.
The U.K. “withdrawing the GMP certification is a big issue, and it’s practically similar to the U.S. Food and Drug Administration issuing an import alert,” said Surya Narayan Patra, a pharmaceutical analyst at Phillip Capital Securities Ltd. “It will take the company at least a year to resolve this.”
Daryl Suchitha, a spokesman for Wockhardt, didn’t immediately respond to an e-mail seeking information on the withdrawal of the permit and a timeline for resolving the issue.
The Chikalthana plant makes metoprolol, a generic version of the heart pill sold by London-based AstraZeneca Plc under the brand name Toprol-XL, among other drugs.
The U.K. regulator will allow the company to continue manufacturing critical drugs for which there is “no feasible alternative in the market,” Wockhardt said in its statement.
When inspectors from the U.S. Food and Drug Administration visited the plant in July, they found urine spilling over open drains, soiled uniforms and mold growing in a raw-material storage area, according to a document obtained by Bloomberg via a Freedom of Information Act request.
Wockhardt has hired consultants, appointed a new quality supervisor and is working on a better compliance system to address the report on Chikalthana, it said through an external public-relations agency in a response to the findings.