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