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