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