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