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Table 4 Number of injections tested for purity by the Formulation WG

From: Scientific and regulatory approaches to confirm quality and improve patient perceptions of generic drug products in Japan

API Formulation Strength Products Method
Cefazolin sodium Injection/sterile powders for injection 1 g/vial 5 JP (formulation)
Cisplatin Injection/solutions 10 mg/vial 6 JP (API), EP, Approval documentation
Elcatonin injection Injection/solutions 10 elcatonin/1 mL/vial 13 JP (API)
Famotidine Injection/sterile powders for injection 20 mg/vial 6 JP (formulation)
Injection/solutions 20 mg/vial 1 Approval documentation
Iopamidol Injection/solutions 61.24 % 50 mL/vial 4 JP (API)
Minocycline hydrochloride for injection Injection/sterile powders for injection 100 mg/vial 6 JP (formulation)
Nafamostat mesilate Injection/sterile powders for injection 10 mg/vial 15 Approval documentation
Nicardipine hydrochloride Injection/solutions 10 mg/vial 7 JP (formulation)
Ozagrel sodium Injection/sterile powders for injection 20 mg/vial 11 JP (formulation)
Injection/solutions 20 mg/vial, 80 mg/vial 5 Approval documentation
Piperacillin sodium Injection/sterile powders for injection 1 g/vial 7 JP (formulation)
Ritodrine hydrochloride Injection/solutions 50 mg/vial 10 JP (API)
Sulbactam sodium/Ampicillin sodium Injection/sterile powders for injection 1.5 g/vial 9 Approval documentation
Vancomycin hydrochloride Injection/sterile powders for injection 0.5 g/vial 8 JP (formulation)
Total 13 formulations   113 products