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