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