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