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