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