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Germany halts cephalosporin injectable export from Ranbaxy's Dewas facility

Our Bureau, MumbaiThursday, December 4, 2014, 13:10 Hrs  [IST]

In a fresh quality problem, Germany's regulatory authority has halted supply of cephalosporin injectable produced by Ranbaxy Laboratories in its Dewas facility. German regulator inspected Dewas facility in June 2014 and found deficiencies in operation of drug manufacturing rooms and procedures related to sterilisation of equipment. Earlier, US FDA issued import alerts to Ranbaxy and banned it from exporting products to US.

After this news, Ranbaxy scrip opened lower at Rs. 621.55 today as against previous close of Rs. 630.60 on Bombay Stock Exchange.    

However, Ranbaxy said in its press release to BSE that 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 time, 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 (active pharmaceutical ingredients) at Dewas including that for oral cephalosporins with the only exception of the cephalosporin injectable unit.

The company said, “We wish to state that Ranbaxy's decision to discontinue manufacture of cephalosporin injectables would not have a significant impact on the business. Further, we wish to clarify that the current approvals cover all other facilities (dosage forms and APIs) at Dewas, including those producing penem API & injections and oral cephalosporins."

 
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