(5R)-5-[(1S)-1,2-dihydroxyethyl]-3,4-dihydroxyfuran-2(5H)-one | 21163 | SOLUTION;INTRAVENOUS | 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML

(5R)-5-((1S)-1,2-DIHYDROXYETHYL)-3,4-DIHYDROXYFURAN-2(5H)-ONE

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ACTIVE PHARMA INGREDIENTS

54 API Suppliers, 9 USDMF, 8 CEP/COS, 14 JDMF, 5 EU WC, 6 KDMF, 6 NDC API, 34 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

16 Drugs in Development

16 Drugs in Development

FINISHED DOSAGE FORMULATIONS

314 FDF Dossiers, 20 FDA Orange Book, 53 Europe, 9 Canada, 65 South Africa, 167 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL, SOLUTION;INTRAVENOUS - 25,000MG/50ML (500MG/ML), SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML, SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML, INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL, INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

RELATED EXCIPIENT COMPANIES

2 Evonik, 14 Rochem International Inc, 22 SPI Pharma, 2 Seqens, 26 DKSH, 2 Jai Radhe Sales, 2 Pharm-RX Chemical, 11 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 2 Kewpie Corporation, 13 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 16 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 36 BASF, 2 Bioplus Life Sciences, 2 Clariant, 13 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 2 Finar, 13 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 34 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 22 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 13 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 39 Roquette, 16 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

121 Fillers, Diluents & Binders, 63 Coating Systems & Additives, 51 Direct Compression, 51 Thickeners and Stabilizers, 45 Taste Masking, 44 Solubilizers, 40 Parenteral, 38 Controlled & Modified Release, 35 Disintegrants & Superdisintegrants, 32 Granulation, 31 Topical, 30 Film Formers & Plasticizers, 25 Lubricants & Glidants, 23 Chewable & Orodispersible Aids, 22 Co-Processed Excipients, 16 Emulsifying Agents, 13 Rheology Modifiers, 11 API Stability Enhancers, 9 Empty Capsules, 7 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 27 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 28 Finished Drug Prices

MARKET PLACE

172 APIs, 34 FDF Dossiers, 13 EXCIPIENTS

PATENTS & EXCLUSIVITIES

13 US Patents, 1 US Exclusivities

REF. STANDARDS & IMPURITIES

5 EDQM, 2 USP, 3 JP, 6 Others

ANALYTICAL

11 Analytical Methods

11 Analytical Methods

$ Xls

Filters

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USFDA APPLICATION NUMBER - 21163 / DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1)	ALPHA-TOCOPHEROL ACETATE	10[iU] in 10
ASCORBIC ACID(UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	200mg in 10
BIOTIN(UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	60ug in 10
CHOLECALCIFEROL(UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	200[iU] in 10
CYANOCOBALAMIN(UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	5ug in 10
DEXPANTHENOL(UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z)	DEXPANTHENOL	15mg in 10
FOLIC ACID(UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	600ug in 10
NIACINAMIDE(UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	40mg in 10
PHYTONADIONE(UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857)	PHYTONADIONE	150ug in 10
PYRIDOXINE HYDROCHLORIDE(UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	6mg in 10
RIBOFLAVIN 5'-PHOSPHATE SODIUM(UNII: 20RD1DZH99) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3.6mg in 10
THIAMINE HYDROCHLORIDE(UNII: M572600E5P) (THIAMINE - UNII:X66NSO3N35)	THIAMINE	6mg in 10
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	3300[iU] in 10

Inactive Ingredients

Ingredient Name	Sandoz Canada Inc
ANHYDROUS CITRIC ACID(XF417D3PSL)
HYDROCHLORIC ACID(QTT17582CB)
POLYSORBATE 80(6OZP39ZG8H)
PROPYLENE GLYCOL(6DC9Q167V3)
SODIUM CITRATE(1Q73Q2JULR)
SODIUM HYDROXIDE(55X04QC32I)

Drug Product Composition: (5R)-5-[(1S)-1,2-dihydroxyethyl]-3,4-dihydroxyfuran-2(5H)-one