Granules India’s Unit V facility located at Anakapally, Visakhapatnam, Andhra Pradesh, India underwent a United States Food and Drug Administration (USFDA) inspection from April 8, 2024 to April 12, 2024. This audit was a Pre Approval Inspection (PAI) and cGMP audit for Active Pharmaceutical Ingredients (APIs) and Formulations (FDs); oncology and non-oncology. The audit resulted in Form-483 with zero observations. This facility manufactures APIs & formulations of oncology and non-oncology products.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).