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