Ranbaxy Laboratories, the home-grown drugmaker, has been barred from exporting the antibiotic Cephalosporin to Germany from its Madhya Pradesh plant for not complying with standard manufacturing practices.
After an inspection in June, Germany's drug regulator issued a 'non-compliance' report for the plant where Ranbaxy made the antibiotic, the European Medicines Agency said on its website in a notice dated November 26.
During the inspection, the German regulator found deficiencies related to operation of drug manufacturing rooms and procedures related to sterilisation of equipment at the Dewas site, the notice said.
The Dewas factory and Ranbaxy's other domestic manufacturing plants are also barred from exporting to the United States after the US Food and Drug Administration (FDA) found in inspections that those plants violated its standard manufacturing practices.
Punjab-based Ranbaxy, which has said it was working on resolving problems at its plants to get the regulatory bans lifted, did not respond to a request seeking comment on the observations made by the German regulator.
The domestic drug major gets over half of its revenue from the US. Germany accounted for 2 per cent of global sales in the 15-month period ended March 31, 2014, as per the company's filings. The latest German sales data, however, was not immediately available.
Ranbaxy is in the process of being acquired by larger rival Sun Pharmaceutical Industries.