Jadcherla facility of Shilpa Medicare receives 15 observations from USFDA

Shilpa Medicare has got 15 observations from US Food and Drug Administration (FDA) for the finished dosage formulation facility (sterile and non-sterile) for Jadcherla facility of the company.

The company stated in a BSE filing that USFDA performed good manufacturing practices (GMP) inspection of the finished dosage formulation facility of company (sterile and non-sterile) located at S-20 to S-26, pharmaceutical formulations SEZ, TSIIC, Jadcherla, Telangana State, India from 13-25, February 2020.

The company is in process of preparing responses to the observations, which will be file to the agency within 15 business days. The company is focused on addressing these observations immediately.