By Dr. Kamal Kant Kohli Ruchika Sharma
Karnataka: Shilpa Medicare Limited’s 100 percent subsidiary, Shilpa Pharma Lifesciences Limited, Unit-1 has successfully completed GMP inspection from Brazilian regulatory authority, ANVISA. The audit was carried out between June 30-July 4, 2025 and has been concluded with No Critical and No Major observations. Few other observations and recommendations were discussed during the inspection, which are procedural related.”Shilpa is committed to respond to the agency through appropriate CAPA plan on the other and recommendations points within the stipulated timelines,” Shilpa informed in a BSE filing.In May, this facility received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) and classified as Voluntary action indicated (VAI). VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.Read also: Shilpa Pharma Lifesciences Unit 1 gets EIR from USFDAShilpa is an integrated pharmaceutical group with business interests in niche Oncology & Non-oncology APIs, Peptides, Polymers, differentiated finished dosage formulations including novel injectables, orally dispersible films & transdermal patches along with carefully crafted biological portfolio. Shilpa also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments based on its R&D and manufacturing capabilities backed by four R&D units and seven manufacturing facilities.Read also: Shilpa Medicare arm partners with Orion Corporation for Recombinant Human Albumin for European Market