The European Union has banned imports from a Ranbaxy Laboratories factory unit that makes injectable antibotics after the unit failed an inspection, the latest in a series of quality-related setbacks for the drugmaker.
European authorities inspected all units at the 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 stock market filing on Thursday.
All other units of the facility were approved, it said, adding the company had decided to stop producing cephalosporin injectables at Dewas before the inspection occurred.
No impact “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 factories, including Dewas, are already barred from exporting to the United States after the U.S. Food and Drug Administration 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.
