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