Shilpa Medicare has informed that the Company has received US FDA Establishment Inspection Report (EIR) on 24 October 2019, for the Finished Dosage Formulation Facility (Sterile and Non-sterile Dosage Forms) located at S-20 to S-26, Pharmaceutical Formulations SEZ, APIIC, Jadcherla, Telangana State, India. The company’s finished dosage form facility was inspected by US FDA from 29th August to 6th September, 2019. FDA has concluded the inspection, with determination that the inspection classification of this facility is ‘voluntary action indicated’ (VAI). This facility is in acceptable state of compliance with regards to current good manufacturing practice (CGMP).
The above information is a part of company’s filings submitted to BSE.
