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