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