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