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