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