USFDA lifts import ban on Mohali facility of Sun Pharma

Drug manufacturer Sun Pharma was informed by the USFDA today about the lifting of ban imposed on its manufacturing facility at Mohali removing the official action initiated status from the facility. This will clear the way for Sun Pharma for supply of approved products to the US markets from the facility.
Post the acquisition of Ranbaxy Lab by Sun Pharma, this facility was inherited by the company in FY15.

In 2013, the US FDA had ordered Mohali facility to be fully subject to Ranbaxy’s Consent Decree of Permanent Injunction. Though the ban is lifted, certain conditions of the consent decree will still be applicable to the facility.

Sun Pharma’s commitment to work closely with the USFDA has been illustrated by this development. Moreover, Sun Pharma strives for 100 per cent compliance of current goods manufacturing practices (CGMP) in its manufacturing facilities.

Several CGMP violations like failure to adequately investigate manufacturing problems and failure to establish adequate procedures to ensure quality were detected in USFDA’s inspection of Ranbaxy’s Mohali facility in September and December 2012. 

Thereafter, all of Ranbaxy’s facilities in India were banned by the USFDA. Sun Pharma has been struggling with regulatory issues at all the Ranbaxy facilities and its own facilities at Halol and Karkhadi.