Mumbai, Sept. 19 -- The inspection concluded with one procedural observation, which was neither a repeat observation nor related to data integrity. The company will submit a comprehensive response to the USFDA within the stipulated timeline, along with appropriate corrective and preventive actions.

The company said it does not expect the observation to have any material impact on its current business operations or existing supplies from the facility.

Shilpa Medicare is a diversified pharmaceutical and biotechnology company engaged in the development and manufacture of complex generics, biologics and active pharmaceutical ingredients (APIs). Through its subsidiary Shilpa Biologicals, the company operates a fully integrated biologics plat...