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