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