US Food and Drug Administration (USFDA) has conducted Good Manufacturing Practices (GMP) inspection of Shilpa Medicare’s Finished Dosage Formulation Facility (Sterile and Non-sterile) located at S-20 to S-26, Pharmaceutical Formulations SEZ, TSIIC, Jadcherla, Telangana State, India from February 13-25, 2020.
At the conclusion of inspection, the Agency issued Form 483, with 15 observations. The company is preparing responses to the observations, which will be submitted to the Agency within 15 business days. The company is committed to address these observations promptly.
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.
