The European Union (EU) has banned imports from a unit of Ranbaxy Laboratories' Dewas plant after it failed an inspection. The ban only extends to the unit that makes injectable antibiotics.
European authorities inspected all units at Ranbaxy's Dewas plant, about 35 km from Indore, in June this year and did not approve the manufacturing practices at the unit that makes injectable cephalosporin antibiotics, Ranbaxy said in a stock market filing. It is the latest in a series of quality-related setbacks for the Indian company.
"The company had decided to stop producing cephalosporin injectables at Dewas even before the inspection by European authorities took place. All other units of the facility were approved. We wish to state that Ranbaxy's decision to discontinue manufacture of cephalosporin injectables would not have a significant impact on the business," company's corporate communication general manager Krishnan Ramalingam said.
All of Ranbaxy India-based 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.
Ranbaxy, which is in the process of being acquired by Sun Pharmaceutical Industries Ltd, has previously said it was working on resolving problems at its plants to get the regulatory bans lifted.
The company generates more than half of its revenue from the United States. Meanwhile, western Europe accounted for about 8% of its global sales in the 15-month period ended March 2014.