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