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