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