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