In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a cis-Tetrahydro-2-oxothieno(3,4-d)imidazoline-4-valeric acid Drug Master File in Korea (cis-Tetrahydro-2-oxothieno(3,4-d)imidazoline-4-valeric acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of cis-Tetrahydro-2-oxothieno(3,4-d)imidazoline-4-valeric acid. The MFDS reviews the cis-Tetrahydro-2-oxothieno(3,4-d)imidazoline-4-valeric acid KDMF as part of the drug registration process and uses the information provided in the cis-Tetrahydro-2-oxothieno(3,4-d)imidazoline-4-valeric acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a cis-Tetrahydro-2-oxothieno(3,4-d)imidazoline-4-valeric acid 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 cis-Tetrahydro-2-oxothieno(3,4-d)imidazoline-4-valeric acid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of cis-Tetrahydro-2-oxothieno(3,4-d)imidazoline-4-valeric acid suppliers with KDMF on PharmaCompass.