In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Gentamicin Sulfate, 100X Solution Drug Master File in Korea (Gentamicin Sulfate, 100X Solution KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gentamicin Sulfate, 100X Solution. The MFDS reviews the Gentamicin Sulfate, 100X Solution KDMF as part of the drug registration process and uses the information provided in the Gentamicin Sulfate, 100X Solution KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gentamicin Sulfate, 100X Solution 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 Gentamicin Sulfate, 100X Solution API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gentamicin Sulfate, 100X Solution suppliers with KDMF on PharmaCompass.