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