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