Registration of domestic and imported APIs (new/supplementary application) 2024-12-12

Classification & Quantity Chemical synthesis APIs: 100+ Fermentation APIs: 20+ Extraction APIs: 10+

Registration of domestic and imported pharmaceutical excipients (new application/change) 2024-12-12

Classification & Quantity Pharmaceutical excipients Ordinary excipients, high-risk excipients, special excipients, chemical synthesis/natural excipients, premix/blend/multi-component/polymer excipients, etc.

Registration of Special Products 2024-12-12

Approved experience of Xizimed DMFs filing of media DMFs filing of enzymes Application for nuclide products Registration of vaccine adjuvants

Registration Filing of Drug Master Files (DMFs) 2024-12-12

Drug Master Files (DMFs) are submissions to Food and Drug Administration (FDA), used to provide confidential, detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storage of human drugs.

Applications for Certification of Suitability to Monograph of European Pharmacopoeia (CEP) 2024-12-12

CEP, also known as COS, that is the certificate of suitability to monograph of European pharmacopeia (COS/CEP), which is a way for APIs to quickly enter the European market.CEP is only applicable to substances already recorded in EP, including chemical APIs, sterile APIs, herbs, etc.

Services of Domestic/International GMP Certification 2024-12-12

New (rebuilt) plant (workshop) Pre-approval GMP inspection Third party simulation audit and deviation correction On-site inspection of drug registration/consistency evaluation