In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 Drug Master File in Korea (871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133. The MFDS reviews the 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 KDMF as part of the drug registration process and uses the information provided in the 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 KDMF to evaluate the safety and efficacy of the drug.
After submitting a 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 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 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 API can apply through the Korea Drug Master File (KDMF).
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