In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a BRT 1500 Drug Master File in Korea (BRT 1500 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of BRT 1500. The MFDS reviews the BRT 1500 KDMF as part of the drug registration process and uses the information provided in the BRT 1500 KDMF to evaluate the safety and efficacy of the drug.
After submitting a BRT 1500 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 BRT 1500 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of BRT 1500 suppliers with KDMF on PharmaCompass.