In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 1,1'-HBCB Drug Master File in Korea (1,1'-HBCB KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1,1'-HBCB. The MFDS reviews the 1,1'-HBCB KDMF as part of the drug registration process and uses the information provided in the 1,1'-HBCB KDMF to evaluate the safety and efficacy of the drug.
After submitting a 1,1'-HBCB 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 1,1'-HBCB API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 1,1'-HBCB suppliers with KDMF on PharmaCompass.