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