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