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