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