Esomeprazole Magnesium Dihydrate

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ACTIVE PHARMA INGREDIENTS

139 API Suppliers, 65 USDMF, 50 CEP/COS, 7 JDMF, 38 EU WC, 79 KDMF, 45 NDC API, 67 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

14 Intermediates Suppliers

14 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

913 FDF Dossiers, 92 FDA Orange Book, 464 Europe, 23 Canada, 86 Australia, 62 South Africa, 186 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED RELEASE;ORAL - EQ 20MG BASE, CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE, CAPSULE, DELAYED REL PELLETS;ORAL - EQ 40MG BASE, FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET, FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 20MG BASE/PACKET, FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 40MG BASE/PACKET, FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 5MG BASE/PACKET, TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 1 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 8 DKSH, 3 Jai Radhe Sales, 6 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 30 BASF, 15 Corel Pharma Chem, 3 DFE Pharma, 3 Doshion Polyscience, 2 Finar, 11 Gangwal Chemicals, 13 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 19 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 18 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

70 Fillers, Diluents & Binders, 69 Coating Systems & Additives, 43 Controlled & Modified Release, 37 Direct Compression, 32 Thickeners and Stabilizers, 29 Solubilizers, 26 Taste Masking, 25 Granulation, 23 Disintegrants & Superdisintegrants, 21 Lubricants & Glidants, 20 Co-Processed Excipients, 18 Film Formers & Plasticizers, 17 Chewable & Orodispersible Aids, 16 Parenteral, 16 Topical, 9 Empty Capsules, 9 Emulsifying Agents, 6 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Rheology Modifiers

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16 DATA COMPILATION #PharmaFlow, 152 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 395 Finished Drug Prices, 16 Annual Reports

MARKET PLACE

67 APIs, 35 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents, 44 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 EDQM, 1 USP, 21 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 21957 / DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ESOMEPRAZOLE MAGNESIUM(UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)	ESOMEPRAZOLE	40mg \| 40mg \| 20mg

Inactive Ingredients

Ingredient Name	Cardinal Health
ALCOHOL(3K9958V90M)
ANHYDROUS CITRIC ACID(XF417D3PSL)
ANHYDROUS DEXTROSE(5SL0G7R0OK)
BUTYL ALCOHOL(8PJ61P6TS3)
D&C RED NO. 28(767IP0Y5NH)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C RED NO. 40(WZB9127XOA)
FERRIC OXIDE YELLOW(EX438O2MRT)
GELATIN(2G86QN327L)
GLYCERYL MONOSTEARATE(230OU9XXE4)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYPROMELLOSES(3NXW29V3WO)
ISOPROPYL ALCOHOL(ND2M416302)
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID(1CS02G8656)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POTASSIUM SORBATE(1VPU26JZZ4)
POVIDONES(FZ989GH94E)
SODIUM HYDROXIDE(55X04QC32I)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)
WATER(059QF0KO0R)

Drug Product Composition: Esomeprazole Magnesium Dihydrate