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