The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
Increases efficiency by 70% compared to stainless steel or glass manufacturing methods
A new initiative to contribute to enhancing drug discovery capabilities in the field of gene and cell therapy in Japan
ALS patients experience neuroinflammation and rapid neurodegeneration
More than 10 oral and mini-oral presentations span Pfizer’s extensive Oncology portfolio of approved and investigational therapies
Agreement further expands Aptar Pharma’s leading respiratory portfolio
The study observed 2,648 girls, of which 2,300 completed the standard 45-day programme
The recent inspection covered both cGMP and PAI processes
Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.
Subscribe To Our Newsletter & Stay Updated
