Indian drugmaker Ranbaxy Laboratories faces long delays and high costs in launching big-selling generic drugs in the United States after products from a fourth plant were banned from entering its main market due to manufacturing violations.
The US Food and Drug Administration’s sanction is the latest in a series of regulatory rebukes for India’s largest drugmaker by revenue since Japan’s Daiichi Sankyo took control of the company in 2008, and deals a further blow to the $12 billion Indian drug industry.
The FDA said Ranbaxy is prohibited from making and selling pharmaceutical ingredients from its facility in Toansa in Punjab, “to prevent substandard quality products from reaching US consumers.”
The FDA ban on Ranbaxy’s Toansa plant followed an inspection completed on January 11.
The US regulator had previously barred products from the company’s facilities in Paonta Sahib, Dewas and Mohali in India as part of a 2012 consent decree designed to ensure compliance with good manufacturing practices.
Indian drugmakers are among the world’s biggest producers of cheap generic medicines. Demand for generics is on the rise as the United States battles rising health-care costs and as more big-selling branded drugs go off-patent in western markets.
But the rise in demand for generic drugs has led to closer regulatory scrutiny and sanctions imposed on top drugmakers including Ranbaxy and Wockhardt, which has been hit by import bans from both the FDA in the United States and Britain’s drug regulator.