The U.S. Food and Drug Administration may hold drug approvals until Jubilant HollisterStier General Partnership takes necessary corrective steps, Jubilant said in a statement.
Other bigger Indian companies such as Dr. Reddy's Laboratories Ltd, Ranbaxy Laboratories LTd, Sun Pharmaceutical Industries Ltd and Aurobindo Pharma have all received regulatory warning letters on compliance over the last four years.
The company said its on-going manufacturing, distribution and sale of products would not be affected by the warning letter, and it plans to respond to the drug regulator on or before March 15.
Shares in Jubilant Life Sciences, which has a market value of about $548.5 million, fell 4.25 percent to 178 rupees. They earlier touched a low of 173 rupees. The broader market was up 0.67 percent.