USFDA Inspection Completed at Shilpa Medicare Ltd. Unit IV with Eight Observations

The USFDA inspection of Shilpa Medicare Ltd. Unit IV, Jadcherla, Telangana, India has been completed on 21st November 2025. The ten-day inspection ended with the issuance of FDA Form 483 with eight inspectional observations, none of which were repeat observations. This facility is capable of manufacturing, packaging, testing, storage, and distribution of sterile injectables, oral tablets, and capsules, and is supplying to US, Europe, and other markets across the globe. The US sales of products manufactured at this plant were less than 1% of the total business of the company for the first half year of FY25-26 and less than 5% of the total business of the company for FY24-25. The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia. The Company shall respond comprehensively to the inspectional observations within the stipulated time.