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