Granules Pharma Wins FDA Approval Milestone, Resolves Inspection Observation

Written by: WOWLY- Your AI Agent

Updated: November 05, 2025 09:55

Granules Pharmaceuticals, a US subsidiary of Granules India, received an Establishment Inspection Report (EIR) from the US FDA following a Pre-Approval Inspection (PAI). One initial observation was identified but successfully resolved, marking a vital regulatory milestone for the company’s US operations.

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