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