Omeprazole

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ACTIVE PHARMA INGREDIENTS

109 API Suppliers, 42 USDMF, 38 CEP/COS, 9 JDMF, 25 EU WC, 25 KDMF, 33 NDC API, 2 VMF, 69 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

24 Intermediates Suppliers

24 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

943 FDF Dossiers, 95 FDA Orange Book, 571 Europe, 11 Canada, 53 Australia, 40 South Africa, 173 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED REL PELLETS;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, DELAYED REL PELLETS;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, DELAYED REL PELLETS;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 325MG;40MG, TABLET, DELAYED RELEASE;ORAL - 81MG;40MG, TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL - 20MG, CAPSULE;ORAL - 20MG;1.1GM, CAPSULE;ORAL - 40MG;1.1GM, TABLET, DELAYED RELEASE;ORAL - 20MG, CAPSULE;ORAL - 20MG;1.1GM, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 5 Rochem International Inc, 20 SPI Pharma, 2 Seqens, 13 DKSH, 2 Pharm-RX Chemical, 9 Faran Shimi Pharmaceutical, 10 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 3 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 40 BASF, 1 Bioplus Life Sciences, 15 Corel Pharma Chem, 7 DFE Pharma, 3 Doshion Polyscience, 4 Finar, 13 Gangwal Chemicals, 14 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 38 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 9 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 14 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

100 Fillers, Diluents & Binders, 77 Coating Systems & Additives, 51 Direct Compression, 48 Controlled & Modified Release, 45 Thickeners and Stabilizers, 44 Disintegrants & Superdisintegrants, 38 Solubilizers, 36 Granulation, 30 Taste Masking, 29 Lubricants & Glidants, 27 Topical, 23 Co-Processed Excipients, 22 Chewable & Orodispersible Aids, 22 Parenteral, 22 Film Formers & Plasticizers, 10 Emulsifying Agents, 9 Rheology Modifiers, 9 Empty Capsules, 8 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

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3 US Medicaid Prescriptions, 523 Finished Drug Prices, 9 Annual Reports

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61 APIs, 71 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

14 US Patents, 23 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 5 USP, 50 Others

ANALYTICAL

3 BioAnalytical Methods, 1 Analytical Methods

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USFDA APPLICATION NUMBER - 205103 / DOSAGE - TABLET, DELAYED RELEASE;ORAL - 81MG;40MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
aspirin(UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E)	aspirin	81mg \| 325mg
omeprazole(UNII: KG60484QX9) (omeprazole - UNII:KG60484QX9)	omeprazole	40mg \| 40mg

Inactive Ingredients

Ingredient Name	Innovida Phamaceutique Corporation
carnauba wax(R12CBM0EIZ)
FD&C blue no. 2(L06K8R7DQK)
ferric oxide yellow(EX438O2MRT)
glyceryl monostearate(230OU9XXE4)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
methacrylic acid - ethyl acrylate copolymer (1:1) type A(NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
polydextrose(VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
polysorbate 80(6OZP39ZG8H)
POVIDONE, UNSPECIFIED(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
sodium phosphate, dibasic, anhydrous(22ADO53M6F)
STARCH, CORN(O8232NY3SJ)
stearic acid(4ELV7Z65AP)
talc(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)
triacetin(XHX3C3X673)
triethyl citrate(8Z96QXD6UM)

Drug Product Composition: Omeprazole

Omeprazole

Omeprazole

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

109 API Suppliers

42 USDMF

38 CEP/COS

9 JDMF

25 EU WC

25 KDMF

33 NDC API

2 VMF

69 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

INTERMEDIATES

24 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

943 FDF Dossiers

95 FDA Orange Book

571 Europe

11 Canada

53 Australia

40 South Africa

173 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED REL PELLETS;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, DELAYED REL PELLETS;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, DELAYED REL PELLETS;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, DELAYED RELEASE;ORAL - 325MG;40MG

TABLET, DELAYED RELEASE;ORAL - 81MG;40MG

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL - 20MG

CAPSULE;ORAL - 20MG;1.1GM

CAPSULE;ORAL - 40MG;1.1GM

TABLET, DELAYED RELEASE;ORAL - 20MG

CAPSULE;ORAL - 20MG;1.1GM

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

2 Evonik

5 Rochem International Inc

20 SPI Pharma

2 Seqens

13 DKSH

2 Pharm-RX Chemical

9 Faran Shimi Pharmaceutical

10 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

15 Gangwal Healthcare

10 Nanjing Well Pharmaceutical

2 Pfanstiehl

4 ACG Worldwide

9 Actylis

1 Aeon Procare

3 Alcedo Pharmachem

11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

40 BASF

1 Bioplus Life Sciences

15 Corel Pharma Chem

7 DFE Pharma

3 Doshion Polyscience

4 Finar

13 Gangwal Chemicals

14 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

38 Kerry

4 Kima Chemical

6 Lonza Capsugel

19 Microlex e.U

2 Nanjing Bold Chemical

1 NEWEDGE Overseas

2 Nomisma Healthcare

3 Novo Excipients

5 Pharmatrans-Sanaq

9 Pluviaendo

CAPSULE, DELAYED REL PELLETS;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, DELAYED REL PELLETS;ORAL - 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, DELAYED REL PELLETS;ORAL - 40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons