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