Shilpa Medicare’s Formulations Facility Gets U.S. FDA Warning Letter

Shilpa Medicare Ltd.'s formulations facility in Jadcherla, Telangana has received a warning letter from the U.S. Food and Drug Administration, the company stated in a filing to the exchanges.

This is the second instance of a pharmaceutical company getting a warning letter from the U.S. drug regulator over the last ten days, after Panacea Biotech's Baddi unit had received a warning letter on September 30.

The company in its statement said that it expects minimum impact of this warning letter. “The warning letter will have minimum impact of disruption of supplies and existing revenues from operations of this facility,” the statement said.

The company's formulations business had a contribution of 21% to its overall revenue in FY20, according to a note by JM Financial.

The company currently has three facilities, including the formulations facility in Jadcherla. The other two are API units. “None of the other facilities except Jadcherla has any outstanding issues with the U.S. FDA.,” the exchange filing said.