Ranbaxy gets hit by FDA again

Ranbaxy stock took a 30% hit today following an import alert issued by the FDA. The alert was reportedly issued based on serious cGMP issues at the Mohali plant from September and December 2012 483s.  Ranbaxy’s other two plants in India were already barred from importing to the U.S., this third plant in India was supposed to be the model plant, paving the way to a recovery. Obviously, this is a huge blow to the company.

For more context on Ranbaxy’s tumultuous year, read FiercePharmaManufacturing’s write-up.  FDAzilla has the September 2012 FDA 483 available for immediate purchase and download in the FDAzilla store.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.

 

 

Leave a Reply

Your email address will not be published. Required fields are marked *