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