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