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