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