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