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