Ranbaxy gets USFDA clean chit for Ohm Laboratories

Beleaguered drug maker Ranbaxy has found some respite. The drug maker which has seen the ire of the US drug regulator, has now received a clean chit for its New-Jersey based Ohm Laboratories, reports CNBC TV18’s Archana Shukla.

In a statement, Ranbaxy said that Ohm Labs has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for its December 2012 inspection. Also read: Ranbaxy can give high returns but extremely risky: Dron Cap An EIR is a signal that all the issues and concerns of non-compliance observed by the US FDA in its December audits has been satisfactorily resolved. The US drug regulator had issued a Form 483 with its observations, highlighting non-compliance to current Good Manufacturing Practices (cGMP) at Ohm Labs. However, the company now has successfully rectified the errors. The news is positive for Ranbaxy as Ohm Labs is currently the only facility certified to supply to the US market. Ranbaxy’s other units – Paonta Sahib, Dewas and even Mohali are barred and under a consent decree of US FDA following severe deviations from cGMP norms.
 
A clean-chit for Ohm also brings hope for fresh approval for drugs filed from Ohm Labs. It could mean the long pending approvals for Ranbaxy’s large first-to-file opportunities of hypertension drug Diovan and anti-viral drug Valcyte, could be on its way too. Also for the anti-ulcer drug Nexium, it is an exclusive marketing opportunity for Ranbaxy, which comes up in 2014. The stock had also gained 3.28 percent in today’s trade too on positive news. It closed at Rs 393.15.