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