Shilpa Pharma Lifesciences’ Unit 2 Raichur has cleared the ANVISA-Brazil GMP inspection
The Unit has been issued GMP Certification from ANVISA-Brazil
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
The inspection was concluded with few procedural observations
The company will provide comprehensive response to USFDA for the observations
The company intends to respond to the two minor observations within the stipulated time
The company has received Form 483 with three observations
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