New Delhi: The Food and Drug Administration (FDA) has issued two warning letters to Ranbaxy Laboratories Ltd and an import alert for generic drugs produced by the company’s Dewas and Paonta Sahib plants in India.
The letters identify the agency’s concerns about deviations from US current Good Manufacturing Practice (cGMP) requirements at Ranbaxy’s manufacturing facilities in the above-mentioned locations.
Due to 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 United States.
The problems at these two Ranbaxy plants relate to deficiencies in the company’s drug manufacturing process.
While this action does not involve removing products from the market, FDA has no evidence to date that the Indian pharma company has shipped defective products.
However, the announcement does not impact products from Ranbaxy’s other plants that are not affected by today’s actions. FDA has inspected those facilities and, to date, they have met US cGMP requirements for drug manufacturing.
“With this action we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality,” said Janet Woodcock, M.D., director, FDA’s Center for Drug Evaluation and Research (CDER).
“The FDA has notified other agencies and health care professionals to make them aware of today’s actions so that they can take appropriate action and advise patients as needed,” Woodcock added.
Ranbaxy has also been informed that until it resolves the deficiencies at each of these two facilities, 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 these plants as the manufacturer of APIs or finished drug products.
Ranbaxy is one of the largest foreign suppliers of generic drugs to the United States.
The FDA import alert covers more than 30 different generic drug products produced in multiple dosage forms and dosage amounts (i.e., 25 mg, 50 mg, and 100 mg) at these two locations.