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