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