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