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