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