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