Ranbaxy’s Injectable Antibiotic Drug Banned From EU

The European Union has banned imports of Ranbaxy’s injectable antibiotic cephalosporin following an inspection by German regulators who found the company’s Dewas, India, facility was not in compliance with good manufacturing practices.

Germany’s noncompliance report, issued late last month, stems from a June 27 visit to the plant that uncovered deficiencies with the operation of cleanrooms and the sterilization of equipment.

The ban does not require the EU to recall products already delivered to EU states from the plant. The remaining areas at the Dewas site have been found to be compliant with GMPs, the European Medicines Agency said.

Ranbaxy said it discontinued production of injectable cephalosporin after the June inspection, but that its decision was made prior to the visit. Discontinuing the product is not expected to have a significant impact on business, Ranbaxy said.

Since the inspection, Ranbaxy’s facilities in Dewas have received EU approval for manufacturing dosage forms and active pharmaceutical ingredients, including oral cephalosporin, the company said.

The Dewas facility is one of five Ranbaxy plants that the FDA cited for GMP violations and subjected to a 2012 consent decree that prohibits the manufacture of products for the U.S. market.

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