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