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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 US 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 US FDA was not immediately reachable for comment.
Ranbaxy shares were down 2.8 percent at 9.40 a.m., compared with a 0.7 percent fall in the broader Nifty.
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