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