EU bans imports from Ranbaxy's antibiotic injectables unit

This follows close on the heels of Germany's ban on antiobiotic drug from the Dewas unit

Following the US import alerts from the USFDA, Ranbaxy is now reeling under the restrictions brought by European Union. The European Union has banned imports from a Ranbaxy Laboratories factory unit in Dewas in Madhya Pradesh. Dewas facility makes injectable antibotics.

European authorities inspected all units at Ranbaxy's Dewas plant, in Madhya Pradesh, in June and did not approve the manufacturing practices at the unit that makes injectable cephalosporin antibiotics, Ranbaxy said. According to the statement, Ranbaxy had decided to stop producing cephalosporin injectables at Dewas before the inspection occurred.

"The European authorities along with those from Australia and Canada carried out an inspection in June 2014 of all the facilities in Dewas. The agencies have approved all our facilities for manufacturing Dosage Forms and APIs (Active Pharmaceutical Ingredients) at Dewas including that for oral cephalosporins with the only exception of the cephalosporin injectable unit," the Ranbaxy statement said.  

Ranbaxy's decision to discontinue manufacture of Cephalosporin injectables would not have a significant impact on the business, it added. On BSE, shares of Ranbaxy were closed at Rs 627.55, down by 0.48% on Thursday.

For the quarter ended September 2014, Ranbaxy reported a better growth of sales in Europe, driven by performance in UK, Germany, Spain and North Europe. European sales stood at Rs 2,33 crore, a growth of 17% over the corresponding quarter. The latest EU ban on the Dewas plant was enforced after German regulators placed a ban due to Current Good Manufacturing Practices (cGMPs) violation.
 
Two months after Japanese company Daiichi Sankyo bought Ranbaxy for $4.6 billion in July 2008, US FDA issued an import alert on Dewas and Paonta Sahib plants of Ranbaxy, which affected sales of 30 generic drugs of Ranbaxy in the US. Since then, about four plants of Ranbaxy in India came under USFDA scrutiny, resulted in a ban of Ranbaxy's generic drugs in the US.

Early this year, the USFDA had banned the import of products from Ranbaxy’s plant in Punjab due to manufacturing violation. Toansa was the fourth unit of the company that is banned by FDA after Paonta Sahib, Dewas and Mohanli plants.