Fentanyl Citrate

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ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 14 USDMF, 12 CEP/COS, 3 JDMF, 3 EU WC, 4 KDMF, 16 NDC API, 16 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

279 FDF Dossiers, 77 FDA Orange Book, 159 Europe, 14 Canada, 3 South Africa, 26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE, TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 17 SPI Pharma, 4 Faran Shimi Pharmaceutical, 2 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 BASF, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Finar, 5 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 17 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 8 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

59 Fillers, Diluents & Binders, 42 Coating Systems & Additives, 34 Direct Compression, 28 Disintegrants & Superdisintegrants, 23 Controlled & Modified Release, 18 Thickeners and Stabilizers, 17 Taste Masking, 16 Granulation, 15 Co-Processed Excipients, 15 Chewable & Orodispersible Aids, 11 Lubricants & Glidants, 11 Film Formers & Plasticizers, 9 Parenteral, 5 Empty Capsules, 5 API Stability Enhancers, 5 Solubilizers, 4 Vegetarian Capsules, 3 Emulsifying Agents, 3 Topical, 3 Rheology Modifiers, 2 Coloring Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 35 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 103 Finished Drug Prices

MARKET PLACE

11 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

36 US Patents, 17 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 3 Others

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 20747 / DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FENTANYL CITRATE(UNII: MUN5LYG46H) (FENTANYL - UNII:UF599785JZ)	FENTANYL	200ug \| 400ug \| 600ug \| 800ug \| 1200ug \| 1600ug

Inactive Ingredients

Ingredient Name	Cephalon, LLC	CIMA LABS INC.	Lake Erie Medical DBA Quality Care Products LLC	Par Pharmaceutical Inc.
ANHYDROUS CITRIC ACID(XF417D3PSL)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
DEXTRATES(G263MI44RU)
FD&C BLUE NO. 1(H3R47K3TBD)
MAGNESIUM STEARATE(70097M6I30)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(461P5CJN6T)
PROPYLENE GLYCOL(6DC9Q167V3)
RASPBERRY(4N14V5R27W)
SHELLAC(46N107B71O)
SODIUM PHOSPHATE, DIBASIC(GR686LBA74)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(22ADO53M6F)
STARCH, CORN(O8232NY3SJ)
SUCROSE(C151H8M554)

Drug Product Composition: Fentanyl Citrate