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