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