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