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