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