In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Thiophosphamide Drug Master File in Korea (Thiophosphamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Thiophosphamide. The MFDS reviews the Thiophosphamide KDMF as part of the drug registration process and uses the information provided in the Thiophosphamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Thiophosphamide 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 Thiophosphamide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Thiophosphamide suppliers with KDMF on PharmaCompass.