Apitoria Pharma receives 5 observations from USFDA for API facility
At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
The $700 million project is part of Roche’s $50 billion investment in US manufacturing, infrastructure and R&D
This strategic investment strengthens Cohance's integrated oligonucleotide platform
The companies will now begin detailed contract negotiations and proceed with necessary consultations and approval processes
The inspection was conducted from July 22-25, 2025
This GMP certification for our sterile drug product manufacturing facility, Goa Plant II is a testament to our relentless efforts to supply quality and affordable medicines across geographies
This achievement underscores our unwavering commitment to upholding the highest standards of quality, safety, and regulatory compliance
The receipt of EIR reaffirms the company's commitment to maintaining global quality standards
Subscribe To Our Newsletter & Stay Updated