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