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