Drug Approval | July 27, 2025
Concord Biotech successfully completes Russian GMP inspection at its API facility
The inspection was conducted from July 22-25, 2025
The inspection was conducted from July 22-25, 2025
This collaboration aims to bridge India’s talent and translational gap in this rapidly growing field by equipping professionals with practical expertise in the manufacturing of advanced therapies.
This achievement underscores our unwavering commitment to upholding the highest standards of quality, safety, and regulatory compliance
Apotex will also pay US$ 2.5 million upon receipt of final USFDA approval of the ANDA that is the subject of the Collaboration Agreement for Paclitaxel Protein-Bound Particles for Injectable Suspension
The wholly owned subsidiary will carry on the business of all types of research and development and other related services
J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA
SUP will obtain regulatory approvals for selling Tiotropium DPI in China
These observations are procedural in nature and none of them are related to data integrity
Ami Organics’ Ankleshwar Unit II gets GMP compliant by PMDA Japan
Amaran Biotech boasts Taiwan’s first fully automated robotic aseptic filling line, offering high-quality and low-waste filling solutions for high-value pharmaceuticals
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