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