Shilpa Medicare Telangana facility receives 8 USFDA observations
Karnataka: Shilpa Medicare has announced that the U.S. Food and Drug Administration (USFDA) has concluded an inspection with eight observations at the company's Unit IV, Jadcherla, Telangana, India.
The ten-day inspection was completed on 21st November 2025.
"The ended with the issuance of FDA Form 483 with eight inspectional observations none of which has been categorized as a repeat observation. The Company shall respond comprehensively to the inspectional observations within the stipulated time," the company stated in a BSE filing.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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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.
Shilpa Medicare is a global pharmaceutical company specializing in contract development and manufacturing services for small and large molecules. With a strong emphasis on oncology and a growing presence in biologics, the company offers comprehensive solutions from discovery to commercial supply. Shilpa Medicare operates R&D and manufacturing facilities, serving partners across North America, Europe, and Asia.
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