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