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