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