The EU certification will support supplies of drug products registered in Europe, from this manufacturing site
The company expects this approval in Baddi to pave the way for GMP certifications from European Medicines Agency and other PIC/S member nations
The approval paves the way for consolidating the company’s position in Kenya and other African markets as part of its global expansion plans
These announcements are in line with Croda Pharma’s strategy to “Empower Biologics Delivery” and follows news on investments, earlier this year, to expand Croda Pharma’s global manufacturing capabilities to enable the next generation vaccines and therapeutic drugs.
Bourgoin early development hub broadens offerings for oral solid dose formulations
The observations are procedural in nature
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
Resomer used in commercial 3D-printed implants for both soft and hard tissue applications
The company expects the GMP approval from Saudi Food and Drug Authority (SFDA) to soon pave the way for marketing authorizations from the largest market in the GCC region
Cipla has received 8 inspectional observations in Form 483
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