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