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