USFDA to Lift Import Ban on Sun-Ranbaxy Mohali Plant

Drugmaker Sun Pharmaceutical Industries’s Mohali plant is poised to see the lifting of a United States-imposed import ban on it products. The Mohali plant came into the Sun-fold through its $4-billion Ranbaxy acquisition in 2015.

Sun Pharma said that it was informed by the US Food and Drug Administration on Monday “that it will lift the Import alert imposed on the Mohali (Punjab) manufacturing facility and remove the facility from the Official Action Initiated (OAI) status.”

This proposed action will clear the path for Sun Pharma to supply approved products from Mohali to the US market, subject to normal USFDA regulatory requirements, the Mumbai-based drugmaker said.

The company is in the throes of remediation efforts with the USFDA at some of its other plants that include owned facilities and inherited ones from Ranbaxy.

The USFDA had taken action against the Mohali facility in 2013 when it ordered the facility to be fully subject to Ranbaxy’s Consent Decree of Permanent Injunction. Certain conditions of the consent decree will continue to be applicable to the Mohali facility, Sun Pharma said, without giving details. The development is a breather for not just Sun Pharma but other Indian drug majors also caught up in remediation efforts for years now.