The regulator found deficiencies related to operation of drug manufacturing rooms and procedures related to sterilisation of equipment at the Dewas site in Madhya Pradesh
Drugmaker Ranbaxy Laboratories has been barred by from exporting the antibiotic cephalosporin to Germany from its plant in Madhya Pradesh for not complying with standard manufacturing practices.
According to a report in Reuters, Germany’s regulator issued a ‘non-compliance’ report for the plant where Ranbaxy made the antibiotic, after an inspection in June, the European Medicines Agency said on its website in a notice dated Nov. 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 in Madhya Pradesh, the notice said.
The Dewas factory and Ranbaxy’s other India-based plants are also barred from exporting to the US after the US Food and Drug Administration (FDA) inspections found those plants violated its standard manufacturing practices.
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.
Ranbaxy gets more than half of its revenue from the US. Germany accounted for two per cent of global sales in the 15-months period ended March 2014, as per the company filings. The latest German sales data was not immediately available.
Ranbaxy is in the process of being acquired by larger rival Sun Pharmaceutical Industries.
EP News Bureau – Mumbai