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