Ranbaxy Active Pharmaceutical Ingredients Banned from FDA-Regulated Drugs

Through a consent decree issued in January 2014, the FDA prohibited Ranbaxy Laboratories, Ltd., (Ranbaxy) from manufacturing and distributing active pharmaceutical ingredients (APIs) for use in FDA-regulated drug products from its Toansa, India, facility.

According to a press release, an FDA inspection of the Toansa facility identified violations of current good manufacturing practice (CGMP) requirements, which are the main safeguard of drug manufacturing quality. The violations included the retesting of raw materials, intermediate drug products, and finished API to produce acceptable findings following failed analytical testing. The failed tests were not investigated or reported.

The consent decree requires Ranbaxy to hire a third-party expert to conduct a thorough inspection of the Toansa facility. The expert must certify that the facility and its methods and controls are in continuous compliance with CGMP, and the FDA must be satisfied that the quality issues witnessed have been addressed, before Ranbaxy may resume manufacturing and distributing API for FDA-regulated drugs.

Because of the potential for drug shortage issues, the FDA may modify the consent decree in order to ensure patient access to necessary drugs for which safety, quality, and effectiveness have been assured. Patients are advised not to disrupt drug therapy and to talk with a health care professional before discontinuing any treatment.