Ranbaxy's drugs from antibiotic injectables unit banned in Europe

Ranbaxy Laboratories has been banned by the European Union from exporting from a factory unit in Madhya Pradesh that makes injectable antibotics, after the unit failed an inspection, the latest in a series of quality-related setbacks for the home-grown drugmaker.

European authorities inspected all units at Ranbaxy's Dewas plant, in Madhya Pradesh, in June and did not approve the manufacturing practices at the unit that makes injectable Cephalosporin antibiotics, Ranbaxy said in a filing to the stock market on Thursday.

All other units of the facility were approved, the drugmaker said, adding that Ranbaxy had decided to stop producing Cephalosporin injectables at Dewas before the inspection occurred.

"We wish to state that Ranbaxy's decision to discontinue manufacture of Cephalosporin injectables would not have a significant impact on the business," Ranbaxy said.

All of Ranbaxy's domestic factories, including Dewas, are already barred from exporting to the United States after the US Food and Drug Administration (FDA) said its inspections found manufacturing quality lapses.

The latest EU ban on the Dewas plant was enforced after German regulators also found quality lapses during an inspection of the site. The European Medicines Agency, in its statement dated November 26, did not specify, however, if the ban was on the oral or injectable Cephalosporin antibiotics units.

An EMA spokeswoman said the German regulator's 'non-compliance' report meant that "certain aseptically prepared sterile products" made at the Dewas unit could not be imported into the European Union.

Ranbaxy, which is in the process of being acquired by larger rival Sun Pharmaceutical Industries, has previously said it was working on resolving problems at its plants to get the bans by regulatory authorities lifted.

The domestic drug major gets more than half of its revenue from the US. Western Europe accounted for about 8 per cent of its global sales in the 15-month period ended March 31, 2014, according to company filings.

(Reuters)