Ban on Ranbaxy's Dewas Products by German Regulators expands to entire European Union
Drugs produced at Ranbaxy's Dewas Plant have been barred from export to all member countries of the European Union for non-compliance to 'good manufacturing practice' norms. The decision was taken on account of non compliance to Good Manufacturing Practices by German Regulators who barred export of an injectable antibiotic from Ranbaxy's Dewas Plant.
An EMA spokesperson told that due to noncompliance to GMP found in Ranbaxy's products, they cannot be imported in the entire European Union which is a 27 member block of European nations including Germany. The EMA official further said that certain aseptically prepared sterile products produced at Block C of the Ranbaxy's Dewas site are not GMP-compliant as found by Germany Regulator and can therefore not be imported into the EU. The remaining Blocks of the Dewas facility, including those manufacturing other aseptically prepared sterile products have been found to be in compliance with GMP. FDA has already banned products made at Ranbaxy's four Indian plants including at Dewas in Madhya Pradesh.
According to Ranbaxy, the discontinuation of its cephalosporin injectable unit would not have any significant impact on business and except for the cephalosporin injectable unit, all its facilities, manufacturing Dosage Forms and APIs (Active Pharmaceutical Ingredients) at Dewas including that for oral cephalosporins have been approved by European, Australian and Canadian authorities.