Shilpa Medicare Dabaspet unit gets VAI classification from USFDA
USFDA inspection
Karnataka: Shilpa Medicare Limited has received an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) classification from the U.S. Food and Drug Administration (USFDA) for Unit VI, Dabaspet, Bengaluru, Karnataka, India.
The Good Manufacturing Practice (GMP) inspection was conducted from October 24 – 30, 2024.
Voluntary action indicated means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
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This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms - Oral Dissolving Films and Transdermal Systems.
The Unit is already approved by EMA, Europe; MHRA, UK; SFDA, Saudi and TGA, Australia. This Unit is currently supplying Oral Film products to US and other markets. Transdermal products have been filed in the European market.
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.
