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