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