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