The United States Food and Drugs Administration (USFDA) has completed an inspection at Shilpa Medicare’s Unit IV, Jadcherla, Telangana, India on November 21, 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. 

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.