Germany bars antibiotic drug from Ranbaxy's Madhya Pradesh plant

Germany bars antibiotic drug from Ranbaxy's Madhya Pradesh plant

MUMBAI - Drugmaker Ranbaxy Laboratories Ltd has been barred by from exporting the antibiotic cephalosporin to Germany from its plant in Madhya Pradesh for not complying with standard manufacturing practices.

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, the notice said.

The Dewas factory and Ranbaxy's other India-based plants are also barred from exporting to the United States 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 United States. Germany accounted for 2 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 Ltd.

 

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