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