USFDA concludes inspection at Shilpa Medicare Raichur unit

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-03-15 10:20 GMT   |   Update On 2025-03-15 10:20 GMT

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.

Read also: Shilpa Medicare Gets CDSCO Panel Nod for Novel NAFLD Drug, Advances to Marketing Approval Stage

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.

Read also: Shilpa Medicare receives European marketing authorization for Tadalafil Orodispersible Films for erectile dysfunction




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