potassium phosphate (K3-PO4)

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ACTIVE PHARMA INGREDIENTS

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3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

112 FDF Dossiers, 76 FDA Orange Book, 23 Europe, 12 Canada, 1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAVENOUS - 1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML), SOLUTION;INTRAVENOUS - 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML), SOLUTION;INTRAVENOUS - 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML), SOLUTION;INTRAVENOUS - 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML), SOLUTION;INTRAVENOUS - 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)

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2 EUROAPI, 2 Evonik, 7 Rochem International Inc, 19 SPI Pharma, 6 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 3 Pfanstiehl, 13 Kirsch Pharma, 1 ACG Worldwide, 15 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 1 Avesta Pharma, 28 BASF, 1 Bioplus Life Sciences, 3 CD Formulation, 2 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Esteem Industries, 3 Finar, 9 Gangwal Chemicals, 4 Ideal Cures, 5 Ingredion Pharma Solutions, 20 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 10 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 39 Roquette, 8 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 1 Symrise, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

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REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 212832 / DOSAGE - SOLUTION;INTRAVENOUS - 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Potassium Phosphate, Dibasic(UNII: CI71S98N1Z) (Phosphate Ion - UNII:NK08V8K8HR)	Potassium Phosphate, Dibasic	236mg in 1 \| 236mg in 1 \| 236mg in 1
Potassium Phosphate, Monobasic(UNII: 4J9FJ0HL51) (Phosphate Ion - UNII:NK08V8K8HR)	Potassium Phosphate, Monobasic	224mg in 1 \| 224mg in 1 \| 224mg in 1

Inactive Ingredients

Ingredient Name	Fresenius Kabi USA, LLC
water(059QF0KO0R)

Setid 475f5cd7 45bd 412a B419 9962585d6cda Applno 212832 Form Solution Intravenous Dosage 1 18gm 250ml 4 72mg Ml 1 12gm 250ml 4 48mg Ml - Drug Product Composition: potassium phosphate (K3-PO4)