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