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