Providing Customers with“Safe, Highly Efficient and High Quality” Filtration Solutions
– Cobetter Sterilizing Grade Filter Cartridges DMF Acknowledged by the FDA
Cobetter Sterilizing Grade Filter Cartridges are now listed in DMF (Class II DMF Number 031365) which means that they comply with U.S. FDA requirements with the potential to help pharmaceutical customers with New Drug Applications.
According to U.S. laws, all pharmaceutical manufacturers must apply to the FDA for Drug Registration (NDA, ANDA, NADA, and INDA) prior to New Drug Applications while Sterilizing-Grade Filter Cartridge manufactures are asked to provide DMF documents to the FDA for review. DMF contains very detailed technical and manufacturing information with a focus on “Safe, High Quality, and High Efficiency.”
With this DMF acknowledgement for Cobetter Sterilizing Grade Filter Cartridges, Cobetter can help reduce FDA reviewing time prior to New Drug Applications.