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