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