Shares of Ranbaxy Laboratories Ltd fell as much as 2.3 percent on Monday after newspaper Business Standard reported the U.S. Food and Drug Administration had raised concerns about a plant in northern India, citing unidentified sources.
Business Standard said the FDA had issued form 483 to Ranbaxy regarding its Mohali plant. That form is issued when U.S. inspectors see conditions they believe may violate U.S. rules.
A Ranbaxy spokesman declined to comment when asked if the drug maker had received the 483 form.
"We continue to make regulatory submissions from Mohali and will commercialise products from Mohali when we get approvals," he said.
The U.S. FDA was not immediately reachable for comment.
Ranbaxy shares were down 1.8 percent at 0355 GMT, compared with a 0.7 percent fall in the broader NSE index.