Granules India’s US packaging facility clears FDA inspection with zero observations
The inspection concluded with zero observations, confirming the facility's compliance with current Good Manufacturing Practices
The inspection concluded with zero observations, confirming the facility's compliance with current Good Manufacturing Practices
Granules India has reported total income of Rs. 1,384.29 crore during the period ended December 31, 2025
This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
Granules Consumer Health serves as Granules’ front-end division for OTC products in the US
Ascelis Center of Excellence for Peptide Development and Characterization will drive the development of cosmetic, therapeutic, and pharmaceutical peptides
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
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