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