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