Quetiapine Hemifumarate

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ACTIVE PHARMA INGREDIENTS

117 API Suppliers, 59 USDMF, 41 CEP/COS, 9 JDMF, 36 EU WC, 33 KDMF, 34 NDC API, 72 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

13 Drugs in Development

13 Drugs in Development

INTERMEDIATES

34 Intermediates Suppliers

34 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

1365 FDF Dossiers, 198 FDA Orange Book, 700 Europe, 145 Canada, 69 Australia, 109 South Africa, 144 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 200MG BASE, TABLET;ORAL - EQ 25MG BASE, TABLET;ORAL - EQ 300MG BASE, TABLET;ORAL - EQ 400MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 300MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 400MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 2 Seqens, 4 DKSH, 2 Jai Radhe Sales, 5 Faran Shimi Pharmaceutical, 11 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 26 BASF, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 38 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

82 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 41 Disintegrants & Superdisintegrants, 40 Direct Compression, 35 Controlled & Modified Release, 30 Solubilizers, 28 Thickeners and Stabilizers, 27 Granulation, 20 Co-Processed Excipients, 18 Parenteral, 18 Film Formers & Plasticizers, 17 Topical, 16 Lubricants & Glidants, 10 Emulsifying Agents, 9 Taste Masking, 9 Chewable & Orodispersible Aids, 7 API Stability Enhancers, 5 Coloring Agents, 5 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 57 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 541 Finished Drug Prices, 13 Annual Reports

MARKET PLACE

13 APIs, 10 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 Health Canada Patents

14 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 4 USP, 5 JP, 29 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 20639 / DOSAGE - TABLET;ORAL - EQ 25MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
QUETIAPINE FUMARATE(UNII: 2S3PL1B6UJ) (QUETIAPINE - UNII:BGL0JSY5SI)	QUETIAPINE FUMARATE	200mg

Inactive Ingredients

Ingredient Name	McKesson Contract Packaging	NCS HealthCare of KY, Inc dba Vangard Labs	Cardinal Health	Avera McKennan Hospital	Clinical Solutions Wholesale	Lake Erie Medical DBA Quality Care Products LLC	REMEDYREPACK INC.	Breckenridge Pharmaceutical, Inc	American Health Packaging	Bryant Ranch Prepack	Major Pharmaceuticals	Safecor Health, LLC	TYA Pharmaceuticals	Accord Healthcare Inc.	Citron Pharma LLC	Clinical Solutions Wholesale, LLC	Contract Pharmacy Services-PA	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Direct_Rx	Jubilant Cadista Pharmaceuticals Inc.	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	NCS HealthCare of KY, LLC dba Vangard Labs	Northstar RxLLC	NuCare Pharmaceuticals,Inc.	PD-Rx Pharmaceuticals, Inc.	Physicians Total Care, Inc.	Quality Care Products, LLC	TORRENT PHARMACEUTICALS LIMITED	A-S Medication Solutions	Apotex Corp.	Golden State Medical Supply, Inc.	Solco Healthcare US, LLC	BluePoint Laboratories	Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals, Inc.	Proficient Rx LP	RPK Pharmaceuticals, Inc.	Sandoz Inc	TORRENT PHARMACEUTICALS LIMIT	Solco	REMEDYREPACK INC.	Solco Healthcare
ALUMINUM OXIDE(LMI26O6933)
AMMONIUM LAURETH-5 SULFATE(43ZIH89I48)
ANHYDROUS CITRIC ACID(XF417D3PSL)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
colloidal silicon dioxide(ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(M28OL1HH48)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(2S7830E561)
CROSPOVIDONE(68401960MK)
D&C YELLOW NO. 10(35SW5USQ3G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
ETHYLCELLULOSES(7Z8S9VYZ4B)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
FUMARIC ACID(88XHZ13131)
HYDROXYPROPYL CELLULOSE (120000 MW)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (TYPE L)(UKE75GEA7F)
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE(3NXW29V3WO)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
LECITHIN, SOYBEAN(1DI56QDM62)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE K12(333AG72FWJ)
POVIDONE K25(K0KQV10C35)
POVIDONE K26/28(H7AGY1OJO8)
POVIDONE K27(H7AGY1OJO8)
POVIDONE K29/32(390RMW2PEQ)
POVIDONE K30(U725QWY32X)
Povidone K90(RDH86HJV5Z)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
WATER(059QF0KO0R)

Drug Product Composition: Quetiapine Hemifumarate