In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 1,3,7-Trimethylxanthine Drug Master File in Korea (1,3,7-Trimethylxanthine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1,3,7-Trimethylxanthine. The MFDS reviews the 1,3,7-Trimethylxanthine KDMF as part of the drug registration process and uses the information provided in the 1,3,7-Trimethylxanthine KDMF to evaluate the safety and efficacy of the drug.
After submitting a 1,3,7-Trimethylxanthine 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 1,3,7-Trimethylxanthine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 1,3,7-Trimethylxanthine suppliers with KDMF on PharmaCompass.