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