Ranbaxy surges 11% as US plant gets FDA clearance

Moneycontrol Bureau

Shares of Ranbaxy soared around 10.64 percent in early morning trade on Friday as its US plant Ohm Laboratories finally got US Food and Drug Administration (US FDA) clearance. 

In a statement, Ranbaxy said that its New Jersey-based Ohm Labs has received an Establishment Inspection Report (EIR) from the US drug regulator for its December 2012 inspection.

An EIR is a signal that all 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.

Ohm Labs is currently the only facility certified to supply to the US market. Ranbaxy’s other units Paonta Sahib, Dewas and even Mohali plant are barred and are under a consent decree of US FDA following severe deviations from cGMP norms.

At 10:13 hrs Ranbaxy Laboratories was quoting at Rs 412.65, up Rs 19.50, or 4.96 percent on the BSE.