Shilpa Medicare arm gets 1 UFSDA observation for Raichur Unit
Karnataka: Shilpa Medicare has announced that the United States Food and Drugs Administration (USFDA) has concluded an inspection with one observation at Unit-1 of Shilpa Pharma Lifesciences Limited, a wholly owned subsidiary of the Company located at Raichur.
The facility was inspected from March 3-7, 2025.
"On conclusion of inspection, we received 1 (one) observation in form 483, which is procedural in nature," the Company stated.
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
"The company will closely work with the agency and remain committed to address this observation comprehensively within stipulated time," Shilpa Medicare added.
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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.
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