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