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