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