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