Shilpa Medicare has received Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) on October 2019, for the Finished Dosage Formulation Facility (Sterile and Non-sterile Dosage Forms) located at 5-20 to 5-26, Pharmaceutical Formulations SEZ, APIIC, Jadcherla in the state of Telangana.
The company's finished dosage form facility was inspected by US FDA from August 29, 2019 to September 6, 2019. USFDA 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).
Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.