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