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