MUMBAI Jan 13 The U.S. Food and Drug
Administration (FDA) has raised concerns about the manufacturing
practices at a factory owned by Ranbaxy Laboratories Ltd
, the Indian drugmaker said on Monday, sending its
shares down to nearly a one-month low.
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 the regulator's inspection found
violation of its so-called good manufacturing practices.
The company, India's biggest drugmaker by sales, said the
FDA had now filed "certain observations" about its Toansa
pharmaceutical ingredients plant in the northern state of
Failure to address these concerns would result in the FDA
banning all exports to the United States from the factory.
"The company is assessing the observations, and will respond
to the FDA in accordance with the agency's procedure to resolve
the concerns at the earliest," Ranbaxy said in a statement. It
did not give further details.
Shares in Ranbaxy, 63.5 percent owned by Japan's Daiichi
Sankyo Co, fell as much as 9.1 percent on Monday to
421.10 rupees, its lowest level in nearly a month, while the
main Mumbai market index was up 1.1 percent.
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 Ltd.
Last September, the FDA imposed an import ban on Ranbaxy's
factory in Mohali in northern India, saying it had not met "good
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.