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