In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Triethylenethiophosphoramide Drug Master File in Korea (Triethylenethiophosphoramide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Triethylenethiophosphoramide. The MFDS reviews the Triethylenethiophosphoramide KDMF as part of the drug registration process and uses the information provided in the Triethylenethiophosphoramide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Triethylenethiophosphoramide KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Triethylenethiophosphoramide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Triethylenethiophosphoramide suppliers with KDMF on PharmaCompass.