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