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