In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate Drug Master File in Korea (1,4-Bis(2-ethylhexyl) sodium sulfosuccinate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate. The MFDS reviews the 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate KDMF as part of the drug registration process and uses the information provided in the 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate KDMF to evaluate the safety and efficacy of the drug.
After submitting a 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate 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 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate suppliers with KDMF on PharmaCompass.