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