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