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