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