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