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