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