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