Esomeprazole

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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TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

DIGITAL CONTENT

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

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USFDA APPLICATION NUMBER - 204655 / DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 20MG BASE

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

Inactive Ingredients

Ingredient Name	Chain Drug Consortium, LLC	DISCOUNT DRUG MART	Dolgencorp, LLC	Family Dollar, Inc.	Fred's, Inc.	Genomma Lab USA Inc	Harris Teeter	Sam's West Inc	Strategic Sourcing Services LLC	A-S Medication Solutions	Amerisource Bergen	Cardinal Health	CVS Pharmacy	DZA Brands LLC	Family Dollar Services Inc	H E B	Kmart Corporation	Kroger Company	L. Perrigo Company	Publix Super Markets Inc	Rugby Laboratories	Shopko Stores Operating Co., LLC	Wakefern Food Corporation	Wal-Mart Stores Inc
AMMONIA(5138Q19F1X)
D&C RED NO. 28(767IP0Y5NH)
DEXTROSE, UNSPECIFIED FORM(IY9XDZ35W2)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C RED NO. 3(PN2ZH5LOQY)
FD&C RED NO. 40(WZB9127XOA)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
GLYCERYL MONOSTEARATE(230OU9XXE4)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM CARBONATE(0E53J927NA)
MAGNESIUM OXIDE(3A3U0GI71G)
MAGNESIUM STEARATE(70097M6I30)
MEGLUMINE(6HG8UB2MUY)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
STARCH, CORN(O8232NY3SJ)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)

Drug Product Composition: Esomeprazole

Esomeprazole

Esomeprazole

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CHEMISTRY

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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

INTERMEDIATES

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

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