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