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