Exothera will manufacture Meissa’s MV-012-968 vaccine candidate under CGMP regulations to supply Phase 2 clinical trials
As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
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)
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