In a major setback to Indian pharmaceutical giant Ranbaxy, the US has blocked imports of 30 generic drugs, including anti-biotics and cholesterol medicines, produced by it in two of its plants due to "serious" manufacturing deficiencies.
"The Food and Drug Administration (FDA) has issued two warning letters to Ranbaxy Laboratories Limited and an import alert for generic drugs produced by Ranbaxy's manufacturing facilities in Dewas (Madhya Pradesh) and Paonta Sahib (including the Batamandi unit in Uttar Pradesh)", a statement from the administration said.
The warning letters identify the agency's concerns about deviations from US "current good manufacturing practices requirements (cGMP)" at the pharmaceutical major's two manufacturing facilities, it said on Tuesday.
"Because of the extent and nature of the violations, FDA issued an import alert, under which US officials may detain at the U.S. border, any active pharmaceutical ingredients (the primary therapeutic component of a finished drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States", the statement said.
However, this action does not impact products from Ranbaxy's other plants as FDA has inspected those facilities and, to date, they have met US cGMP requirements for drug manufacturing, it said.
Reacting to the FDA decision, Ranbaxy said it "is very disappointed in the action FDA has taken. The company has responded to each concern FDA has raised during the past two years and had thought that progress was being made.
"We are, however, pleased that FDA's testing and review led the agency to conclude that there is no reason to question the safety or effectiveness of Ranbaxy's drugs," the company said in a statement from Gurgaon.
