Germany Bans RanBaxy From Exporting Antibiotic Drug From Its Dewas Plant

After not complying with the standard manufacturing practices, Ranbaxy Laboratories Ltd, an Indian multinational pharmaceutical company, has been banned by Germany from exporting the antibiotic cephalosporin from its Dewas plant located in Madhya Pradesh.

As per a Reuters report, the European Medicines Agency (EMA) on Nov 26 said on its website that Germany's regulator has issued a "non-compliance" report for the plant where Ranbaxy made the antibiotic. The report is based on an inspection conducted in the month of June this year.

While conducting the inspection, the German regulator noticed numerous operation-and-procedured-related deficiencies of drug manufacturing rooms as well as sterilisation of equipment at the Dewas site, the EMA said in the notice.

Earlier, the U.S. Food and Drug Administration (FDA) has barred the Ranbaxy’s Dewas factory along with other India-based plants of the company from exporting drugs to the US as it found those plants violated the standard manufacturing practices enlisted by the FDA.
If we believe media reports, Ranbaxy is working on resolving problems at its plants to get the regulatory bans lifted.

As per the company’s filings, Germany accounted for 2% of the global sales of Ranbaxy in the 15-months period which ended on March 2014.