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