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In this section: Enforcement Activities | FDA

Regulatory Actions Against Ranbaxy and Sun Pharma

The following is a list of regulatory actions related to Ranbaxy Laboratories (Ranbaxy) and Sun Pharmaceutical Industries (Sun Pharma). Sun Pharma announced the acquisition of Ranbaxy in 2014, and the merger was completed in March 2015.

Actions taken under consent decree regarding facility in Toansa, India

Violation of Consent Decree Letter to Ranbaxy (1/23/2014)
FDA News Release: FDA prohibits Ranbaxy’s Toansa, India, facility from producing and distributing drugs for the U.S. market (1/23/2014)
FDA Form 483 (1/11/2014)

Actions taken under consent decree regarding facility in Mohali, India

Consent Decree Correspondence/Non-Compliance Letter to Sun Pharma (5/4/2023)
Resume Operations Letter to Sun Pharma (3/14/2017)
FDA Form 483 (11/29/2016)
Violation of Consent Decree Letter to Ranbaxy (9/12/2013)
FDA News Release: FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy’s Mohali, India, plant and issues import alert (9/16/2013)
FDA Form 483 (12/7/2012)
FDA Form 483 (9/11/2012)

Department of Justice actions against Ranbaxy

DOJ News Release: Generic drug manufacturer Ranbaxy pleads guilty and agrees to pay $500 million to resolve false claims allegations, CGMP violations and false statements to the FDA (5/13/2013)
FDA News Release: Department of Justice files consent decree of permanent injunction against Ranbaxy (1/25/2012)

Application Integrity Policy action for Ranbaxy’s facility in Paonta Sahib, India

FDA Application Integrity Policy Letter to Ranbaxy Laboratories (updated 3/2/2009)
FDA News Release: FDA takes new regulatory action against Ranbaxy’s Paonta Sahib Plant in India (2/25/2009)
Application Integrity Policy List

Import alert for Ranbaxy’s facilities in Dewas and Paonta Sahib, India

FDA News Release: FDA issues warning letters to Ranbaxy Laboratories Ltd., and an import alert for drugs from two Ranbaxy plants in India (9/16/2008)
List of Drugs Manufactured at the Dewas and Paonta Sahib Facilities of Ranbaxy
Questions & Answers on Drugs Manufactured at Dewas and Paonta Sahib Facilities, Ranbaxy
Warning Letter to Ranbaxy — Dewas, India (9/16/2008)
Warning Letter to Ranbaxy — Batamandi (Unit II), Paonta Sahib, India (9/16/2008)

Additional Warning Letters

Warning Letter to Sun Pharma — Halol, India (facility unrelated to Ranbaxy) (December 15, 2022)
Warning Letter to Sun Pharma — Halol, India (facility unrelated to Ranbaxy) (December 17, 2015)
Warning Letter to Ranbaxy — Ohm Laboratories, Gloversville, NY (12/21/2009)
Warning Letter to Ranbaxy — Paonta Sahib, India (6/15/2006)
Warning Letter to Ranbaxy — Princeton, NJ (10/11/2002)

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