Drug Approval | October 30, 2025
Granules India’s facility secures FDA EIR with 'VAI’
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025
It will focus on interface between API and formulation manufacturing, reducing carbon footprint in formulation production, creating intellectual property, training next-generation scientists, and setting new industry benchmarks
The company reported sustained increase in formulations' share despite slowdown in productivity of Gagillapur facility
The company's first-ever corporate-level submission to EcoVadis builds on years of operational and environmental excellence
Strengthening capabilities in Peptide Therapeutics and CDMO services
The acquisition aligns with Granules' vision to enter the rapidly expanding peptide-based anti-diabetic and anti-obesity market
Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
Granules now has a total of 67 ANDA approvals from the USFDA
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