In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a KABIVEN IN PLASTIC CONTAINER-5 Drug Master File in Korea (KABIVEN IN PLASTIC CONTAINER-5 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of KABIVEN IN PLASTIC CONTAINER-5. The MFDS reviews the KABIVEN IN PLASTIC CONTAINER-5 KDMF as part of the drug registration process and uses the information provided in the KABIVEN IN PLASTIC CONTAINER-5 KDMF to evaluate the safety and efficacy of the drug.
After submitting a KABIVEN IN PLASTIC CONTAINER-5 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 KABIVEN IN PLASTIC CONTAINER-5 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of KABIVEN IN PLASTIC CONTAINER-5 suppliers with KDMF on PharmaCompass.