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