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