Pharmaceutical / Drug Definition :
Thought to disrupt parasitic mitochondria and bind to native DNA, leading to structural changes that disrupt metabolic processes and to inhibition of gametocyte and erythrocyte forms. Destroys some gametocytes and makes others incapable of undergoing maturation division.
FDA Label Requirements and Exceptions
FDA Import Information
Primaquine Phosphate (Primaquine Phosphate Entry Refusal)
General U.S. Food and Drug Administration Guidelines for:
- Manufacturers Primaquine Phosphate (Primaquine Phosphate Suppliers)
- Processors Primaquine Phosphate
- Repackers Primaquine Phosphate
- Relabelers Primaquine Phosphate
- Exporters Primaquine Phosphate
- Importers Primaquine Phosphate
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U.S. FDA Regulations:
U.S. FDA Regulation: 21 C.F.R. Part 207
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