USFDA concludes inspection at Shilpa Medicare Raichur unit
Karnataka: Shilpa Medicare has announced that the United States Food and Drug Administration (USFDA) has conducted an inspection at Unit-2 of Shilpa Pharma Lifesciences Limited, a wholly owned subsidiary of the Company, located at Raichur.
The inspection was held from March 10-14, 2025.
The inspection was closed with ZERO observations.
This is second consecutive ZERO 483 inspection from USFDA at this site.
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Shilpa Medicare is an integrated pharmaceutical group with a strong presence in niche oncology and non-oncology active pharmaceutical ingredients (APIs), peptides, polymers, and differentiated finished dosage formulations. The company is also committed to providing end-to-end Contract Development and Manufacturing Organization (CDMO) services to global pharmaceutical companies. Shilpa Medicare operates four R&D units and seven manufacturing facilities, ensuring robust research and manufacturing capabilities.
