Granules India’s Gagillapur facility completes USFDA inspection with six observations
The recent inspection covered both cGMP and PAI processes
The recent inspection covered both cGMP and PAI processes
The inspection was concluded with zero observations
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
The Unit has been issued GMP Certification from ANVISA-Brazil
This facility manufactures APIs & formulations of oncology and non-oncology products.
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
The company is confident of addressing the concern raised by the USFDA
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