German Drug Regulatory Authority (GDRA) on 3 December 2014 decided to bar export of antibiotic drug cephalosporin from Ranbaxy Laboratories.
The move was announced after the Ranbaxy plant at Dewas in Madhya Pradesh failed to comply with standard manufacturing practices.
The GDRA issued a non-compliance report for the plant where Ranbaxy made the antibiotic, after an inspection in June 2014.
During the inspection, the GDRA found deficiencies related to operation of drug manufacturing rooms and procedures related to sterilisation of equipment at the Dewas site.
The Dewas factory and Ranbaxy’s other India-based plants are also barred from exporting to the United States after the U.S. Food and Drug Administration (FDA) inspections found those plants violated its standard manufacturing practices.
Ranbaxy gets more than half of its revenue from the United States. Germany accounted for 2 per cent of global sales in the 15-month period till March 2014.
Where: from Ranbaxy Laboratories
When: 3 December 2014