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