Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The FDA has issued two warning letters to India-based Ranbaxy Laboratories, and an import alert for generic drugs produced by the company's Dewas and Paonta Sahib plants in India.
Subscribe to our email newsletter
The warning letters identify the agency’s concerns about deviations from US current Good Manufacturing Practice (cGMP) requirements at Ranbaxy’s manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India. The problems at these two Ranbaxy plants relate to deficiencies in the company’s drug manufacturing process.
Because of the extent and nature of the violations, FDA has issued an import alert, under which US officials may detain at the US border, any active pharmaceutical ingredients (API) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the US.
The FDA’s announcement does not impact products from Ranbaxy’s other plants which have met US cGMP requirements for drug manufacturing. The FDA has also recommended that consumers continue taking their medications manufactured by Ranbaxy and not disrupt their drug therapy, which could jeopardize their health.
The FDA has also informed Ranbaxy that until it resolves the deficiencies at each of these two facilities and the plants come into compliance with US cGMP requirements, FDA’s drug compliance office will recommend denial of approval of any new drug applications (NDAs) and abbreviated new drug applications (ANDAs) that list the Paonta Sahib or Dewas plants respectively as the manufacturer of APIs or finished drug products.
The FDA import alert covers more than 30 different generic drug products produced in multiple dosage forms and dosage amounts of 25mg, 50mg, and 100mg at these two locations. The FDA has evaluated whether these actions would create any potential drug shortages in the US, and has determined that other suppliers can meet market demand, with one exception.
As Ranbaxy is the sole supplier to the US of Ganciclovir oral capsules (an antiviral drug), to avoid creating a shortage of the drug, the FDA will not detain shipments of this product, and plans to arrange for additional oversight and controls until the company resolves these manufacturing issues.
The FDA has said that it will continue to work with Ranbaxy’s Dewas and Paonta Sahib plants to resolve these issues.