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