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