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