FDA Lifts Import Alert on Sun Pharma’s Indian Manufacturing Plant


From DCAT Value Chain Insights (VCI)

By Pharma News posted 03-16-2017 10:33

  

Sun Pharmaceutical Industries, a Mumbai, India-headquartered specialty generic pharmaceutical company, has been informed by the US Food and Drug Administration (FDA) that the agency will lift an import alert imposed on the company’s manufacturing facility in Mohali, Punjab, India and remove the facility from Official Action Initiated (OAI) status. The proposed action will clear Sun Pharma to supply approved products from the Mohali facility to the US market, subject to normal FDA regulatory requirements.

An OAI status is conferred on a facility when the FDA finds objectionable conditions, and regulatory and/or administrative sanctions by the FDA are indicated.

Sun Pharma gained the Mohali facility with its 2015 acquisition of Ranbaxy Laboratories. The FDA had taken action against the Mohali facility in 2013 when the agency 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 acquired Ranbaxy in 2015 for $3.2 billion plus the assumption of $800 million in debt from Daiichi Sankyo, which held a controlling stake in Ranbaxy, which it acquired in 2008/2009. With the closing of the deal, Ranbaxy was merged with Sun Pharma by means of a share swap, resulting in Sun Pharma as the surviving company and Ranbaxy as the company absorbed, and Daiichi Sankyo becoming the second largest shareholder in Sun Pharma, a stake which Daiichi Sanyko later sold.

Source: Sun Pharmaceutical Industries

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