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