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