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