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