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