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