Last Updated on December 22, 2024 by The Health Master
USFDA
In a disclosure to the Bombay Stock Exchange (BSE), Granules India has announced that the United States Food and Drug Administration (USFDA) has categorized the operational site of Granules Pharmaceuticals, Inc. (GPI), a wholly-owned overseas subsidiary of the Corporation based in Chantilly, Virginia, USA as “Voluntary Action Initiative” (VAI).
Understanding VAI Classification
The VAI assessment signifies that the USFDA will abstain from initiating or advising any authoritative or coercive measures since the detected discrepancies do not presently warrant such actions.
Previous USFDA Assessment
Earlier, it was published that the outcomes of a Good Manufacturing Practices (GMP) audit conducted by the USFDA, which identified five areas for improvement at the Granules Pharmaceuticals, Inc. facility in Chantilly, Virginia, USA.
Regulatory endorsements
Regulatory endorsements from entities such as the USFDA, European Directorate for the Quality of Medicines & Healthcare (EDQM), European Union Good Manufacturing Practice (EUGMP), Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), World Health Organization Good Manufacturing Practice (WHO GMP), Therapeutic Goods Administration (TGA), Korea Food and Drug Administration (KFDA), Drug Enforcement Administration (DEA), Medicines Control Council (MCC), and HALAL underscore its commitment to quality assurance and compliance.
Must read: Drug Regulatory Authorities: Worldwide
Corporate Reach and Regulatory Compliance
Granules India Limited’s extensive reach is bolstered by its expansive distribution network, serving a diverse clientele spanning regulated and semi-regulated markets. The Corporation’s global presence, spanning over 80 countries, is facilitated by strategically positioned offices in India, the United States, and the United Kingdom.
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