The USFDA inspection of Shilpa Medicare Limited, 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 has been categorized as a repeat observation.

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 was 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.