In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Gd-HP-D03A Drug Master File in Korea (Gd-HP-D03A KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gd-HP-D03A. The MFDS reviews the Gd-HP-D03A KDMF as part of the drug registration process and uses the information provided in the Gd-HP-D03A KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gd-HP-D03A 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 Gd-HP-D03A API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gd-HP-D03A suppliers with KDMF on PharmaCompass.