Regulatory Compliance Update
Granules India Limited announced that its wholly-owned US subsidiary, Granules Pharmaceuticals, Inc. (GPI), located in Chantilly, Virginia, has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA). The EIR was issued with a Voluntary Action Indicated (VAI) classification.
Inspection Details
The FDA inspection was conducted from March 30 to April 3, 2026. During this inspection, the FDA issued four Form 483 observations.
Facility Significance
The Chantilly facility is described as playing an important role in Granules' global manufacturing and supply network. The company emphasizes its continued focus on quality systems, regulatory compliance, and patient safety at this facility.
Company Commitment
Granules India Limited reaffirmed its commitment to maintaining the highest standards of quality, safety, and regulatory compliance across all its facilities in both India and the United States.
Company Background
Granules India Limited is a vertically integrated pharmaceutical company headquartered in Hyderabad, India, with a presence across the entire pharmaceutical value chain including Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), Finished Dosages (FDs), and Peptides CDMO. The company has 10 manufacturing facilities globally (7 in India, 2 in USA, 1 in Switzerland) and distributes products to over 300 customers in more than 80 countries.