Authorities in the United States have raised more concerns about the manufacturing practices at a factory owned by Ranbaxy Laboratories, in the latest blow to the Indian pharmaceutical giant.
The company said that the US Food and Drug Administration (FDA) had issued “certain observations” about the Toansa pharmaceutical ingredients plant in the Punjab.
All of Ranbaxy’s India-based factories are currently banned by the FDA from exporting medicines to the United States, the company’s largest market, after inspectors found violations of its so-called good manufacturing practices.
Failure to address these concerns would result in the FDA banning all exports to the United States from the factory.
Shares in Ranbaxy, India’s largest pharmaceutical company in terms of sales, fell as much as 9.1 percent on Monday, its lowest level in nearly a month.
Indian drugmakers are among the world’s biggest producers of cheap generic medicines, as developed nations battle rising healthcare costs and big-selling drugs going off-patent in the lucrative U.S. market.
The rise in demand for generic drugs has led to closer regulatory scrutiny and sanctions imposed on top drugmakers including Ranbaxy and Wockhardt.
Last September, the FDA imposed an import ban on Ranbaxy’s factory in Mohali, saying it had not met “good manufacturing practices”.
The ban on its Mohali factory came after the company pleaded guilty in May to U.S. felony charges related to drug safety and agreed to a record $500 million in fines.