Ranbaxy Laboratories Ltd. Warned by FDA over US current Good Manufacturing Practice

Two warning letters from the FDA were issued to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India.  This is the second time in less than three years that the FDA has issued a warning letter to Ranbaxy.  The warning letters identified the FDA’s concerns about deficiencies and variation from the U.S. current Good manufacturing Practice (cGMP) and quality control requirements at the facilities in India. 

The FDA also issued an Import Alert so that any active pharmaceutical ingredient and sterile and nonsterile finished drug products manufactured at these sites can be detained at the U.S. border.  Since Ranbaxy is the United State’s main source of ganiciclovir, the FDA will not detain shipments of the drug to avoid creating a shortage.  FDA has no evidence that Ranbaxy has shipped defective products, but wanted to take proactive measures to ensure all drugs reaching Americans are manufactured according to cGMP requirements. 

FDA informed Ranbaxy that until it resolves the deficiencies at each of these two facilities and the plants come into compliance with U.S. cGMP requirements, FDA's drug compliance office will recommend denial of approval of any New Drug Applications and Abbreviated New Drug Applications that list the Paonta Sahib or Dewas plants respectively as the manufacturer of active pharmaceutical ingredients or finished drug products.  The warning letter does not impact products from Ranbaxy’s other plants, and the FDA recommends that consumers continue taking their medications manufactured by Ranbaxy.  Patients who are concerned that they are taking one of the more than 30 drug products produced at Dewas and Paonta Sahib plants should discuss their concerns with their health care professional.

References:
www.fda.gov
http://www.ranbaxy.com/news/newsdisp.aspx?cp=899&flag=LN

Ashley Corcoran, PharmD candidate.