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