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