Compliance Management

FDA Lifts Import Alert on India's Sun Pharma Plant

Mar 16, 2017

India's largest drug manufacturer Sun Pharmaceutical Industries announced in a press release that the U.S. FDA lifted the Import Alert imposed on the Mohali (Punjab) manufacturing facility and removed the facility from the Official Action Initiated (OAI) status. This proposed action will allow Sun Pharma to supply approved products from the Mohali facility to the U.S. market, subject to normal US FDA regulatory requirements.

Sun Pharma said the Mohali facility was inherited as part of its acquisition of Ranbaxy Laboratories Ltd. in 2015. The U.S. FDA 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 to ensure compliance with good manufacturing practices. Certain conditions of the consent decree will continue to be applicable to the Mohali facility.

According to an article in Live Mint, Ranbaxy’s units at Dewas in Madhya Pradesh, Paonta Sahib in Himachal Pradesh and Toansa in Punjab are also under U.S. FDA’s import alert. Sun Pharma’s plant at Halol in Gujarat was also issued a warning letter by the FDA in December 2015.