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