Company says that excepting cephalosporin injectable unit, all facilities are compliant
Ranbaxy Laboratories is in trouble once again with Germany citing a unit of the drugmaker’s Dewas plant late last month for non-compliance and imposing a ban on products manufactured at the unit.
The red flags highlighted in the non-compliance report include deficiencies in design and operation of the clean-rooms, controls for preparation of components (including sterilisation) and equipment and controls over aseptic filling.
The European Medicines Agency (EMA) told BusinessLine that the ban would extend across the European Union, though it did not cover all the drugs and products manufactured at the facility.
In a statement, Ranbaxy clarified that the ban pertained to cephalosporin injectables, and that no other formulations would be affected.
Non-compliance report
Explaining the EU-wide ban in an email, an EMA spokesperson said: “This statement of non-compliance entered by the German supervisory authority means that certain aseptically prepared sterile products produced at Block C … are not GMP (good manufacturing practice) compliant and can therefore not be imported into the EU.”
The spokesperson added that products already manufactured in this Block have been assessed and no recall was needed.
In a statement, Ranbaxy said: “The European authorities along with those from Australia and Canada carried out an inspection in June 2014 of all the facilities in Dewas. Well before that, the company had decided to stop producing cephalosporin injectables at Dewas. Since then, the agencies have approved all our facilities for manufacturing dosage forms and APIs at Dewas … with the exception of the cephalosporin injectable unit.”
A senior Ranbaxy official emphasised that about 95 per cent of all the products manufactured by the Dewas plant have been found to be GMP compliant by the European authorities. The decision to stop manufacturing cephalosporin injectables was also a business decision, the official added.
Following volatility through the day, Ranbaxy’s scrip ended the day down 0.48 per cent at Rs.627.55 on the BSE. Business Line
