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