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