Granules India’s wholly owned subsidiary -- Granules Life Sciences (GLS) has concluded a recent US FDA inspection of its manufacturing facility at Shamirpet, Telangana, with an inspection classification of Voluntary Action Indicated (VAI).

The Establishment Inspection Report (EIR) was issued following a current Good Manufacturing Practice (cGMP) and pre-approval inspection (PAI) of the oral solid dosage manufacturing operations conducted between December 15 and 19, 2025. The inspection is now closed, and no regulatory action has been recommended. This development further strengthens Granules India’s finished dosage manufacturing capabilities by enabling multi-site manufacturing for the approved 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).