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