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