Granules India receives Form 483 with 1 observation from USFDA for Bonthapally API unit 1
Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume
Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume
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
The company said it voluntarily paused production at the Gagillapur plant in September 2024 for risk assessment on account of the USFDA observations
Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
Revenue share from the North America increased to 79% in Q2 FY25 as compared to 67% in Q2 FY24
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