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