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