Omperazole | Australian Register of Therapeutic Goods | Australia | PharmaCompass.com

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Omperazole
Australia

With Fermion, start the journey of your innovative API.

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Suanfarma CDMO offers integrated end-to-end solutions for development & commercialization of intermediates & APIs for small molecules.

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Omeprazole

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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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veranova-m-2025-06-30

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jdmfs-not-supported-m-2025-06-30

Omperazole

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

123 API Suppliers, 42 USDMF, 38 CEP/COS, 8 JDMF, 18 EU WC, 24 KDMF, 33 NDC API, 2 VMF, 57 Listed Suppliers, $ API Reference Price

123 API Suppliers
42 USDMF
38 CEP/COS
8 JDMF
18 EU WC
24 KDMF
33 NDC API
2 VMF
57 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

27 Intermediate Suppliers

27 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1027 FDF Dossiers, 96 FDA Orange Book, 571 Europe, 11 Canada, 123 Australia, 40 South Africa, 186 Listed Dossiers

1027 FDF Dossiers
96 FDA Orange Book
571 Europe
11 Canada
123 Australia
40 South Africa
186 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CAPSULE, DELAYED REL PELLETS;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, DELAYED REL PELLETS;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, DELAYED REL PELLETS;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 325MG;40MG, TABLET, DELAYED RELEASE;ORAL - 81MG;40MG, TABLET, ORALLY DISINTEGRATING,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RELEASE;ORAL - 20MG, CAPSULE;ORAL - 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 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**

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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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, 7 Evonik, 5 Rochem International Inc, 21 SPI Pharma, 15 DKSH, 2 Pharm-RX Chemical, 9 Faran Shimi Pharmaceutical, 10 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 4 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 40 BASF, 1 Bioplus Life Sciences, 15 Corel Pharma Chem, 7 DFE Pharma, 3 Doshion Polyscience, 2 Esteem Industries, 4 Finar, 13 Gangwal Chemicals, 13 Ideal Cures, 5 Ingredion Pharma Solutions, 38 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 2 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 9 Pluviaendo, 4 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, 11 Sigachi Industries, 4 Silverline Chemicals, 1 Symrise, 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

97 Fillers, Diluents & Binders, 77 Coating Systems & Additives, 48 Controlled & Modified Release, 45 Thickeners and Stabilizers, 45 Disintegrants & Superdisintegrants, 43 Solubilizers, 39 Direct Compression, 36 Granulation, 31 Taste Masking, 29 Topical, 28 Lubricants & Glidants, 24 Co-Processed Excipients, 22 Chewable & Orodispersible Aids, 22 Film Formers & Plasticizers, 20 Parenteral, 11 Emulsifying Agents, 11 Rheology Modifiers, 9 Empty Capsules, 7 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

97 Fillers, Diluents & Binders
77 Coating Systems & Additives
48 Controlled & Modified Release
45 Thickeners and Stabilizers
45 Disintegrants & Superdisintegrants
43 Solubilizers
39 Direct Compression
36 Granulation
31 Taste Masking
29 Topical
28 Lubricants & Glidants
24 Co-Processed Excipients
22 Chewable & Orodispersible Aids
22 Film Formers & Plasticizers
20 Parenteral
11 Emulsifying Agents
11 Rheology Modifiers
9 Empty Capsules
7 API Stability Enhancers
5 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

84 News #PharmaBuzz

84 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 523 Regulatory FDF Prices, 9 Annual Reports

3 US Medicaid Prescriptions
523 Regulatory FDF Prices
9 Annual Reports

MARKET PLACE

64 APIs, 71 FDF Dossiers, 1 EXCIPIENTS

64 APIs
71 FDF Dossiers
1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

14 US Patents, 23 Health Canada Patents

14 US Patents
23 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 43 Others

3 EDQM
1 USP
43 Others

ANALYTICAL

3 BioAnalytical Methods, 1 Analytical Methods

3 BioAnalytical Methods
1 Analytical Methods

$ API Ref.Price (USD/KG) : 61 Xls

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01 16Alphapharm Pty Ltd

02 16Apotex Pty Ltd

03 16Arrow Pharma Pty Ltd

04 27Pharmaco (Australia) Limited

05 8Pharmacor Pty Limited

06 24Sandoz Pty Ltd

07 16WAGNER PHARMACEUTICALS PTY LTD

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123 All

01 123Omeprazole

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01 123Blank

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01 16APO-Omeprazole

02 8Acimax Tablets

03 11Losec Tablets

04 8Maxor

05 8Maxor EC Tabs

06 8OMEPRAZOLE CAPS WGR

07 8OMEPRAZOLE-WGR

08 8Omepral

09 16Omeprazole Sandoz

10 8Ozmep

11 8Pemzo

12 8Pharmacor Omeprazole 20

13 8Probitor

List of Suppliers

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01

Alphapharm Pty Ltd

Discovery Europe

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Alphapharm Pty Ltd

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Regulatory Info :

Registration Country : Australia

Brand Name : Maxor

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Packaging : 30

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Registration Country : Australia

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02

Apotex Pty Ltd

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Apotex Pty Ltd

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Registration Country : Australia

Brand Name : APO-Omeprazole

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Packaging : 30

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Arrow Pharma Pty Ltd

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Arrow Pharma Pty Ltd

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Brand Name : Pemzo

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Pharmaco (Australia) Limited

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Pharmaco (Australia) Limited

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Brand Name : Acimax Tablets

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Packaging : 30

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Pharmaco (Australia) Limited

Discovery Europe

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Pharmaco (Australia) Limited

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Brand Name : Omepral

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Packaging : 30

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Pharmaco (Australia) Limited

Discovery Europe

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Pharmaco (Australia) Limited

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Brand Name : Losec Tablets

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Pharmacor Pty Limited

Discovery Europe

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Pharmacor Pty Limited

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Registration Country : Australia

Brand Name : Pharmacor Omeprazole 20

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Sandoz Pty Ltd

Discovery Europe

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Sandoz Pty Ltd

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Registration Country : Australia

Brand Name : Omeprazole Sandoz

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Packaging : 30

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Sandoz Pty Ltd

Discovery Europe

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Sandoz Pty Ltd

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Registration Country : Australia

Brand Name : Omeprazole Sandoz

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Packaging : 30

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Sandoz Pty Ltd

Discovery Europe

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Sandoz Pty Ltd

Discovery Europe

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Brand Name : Probitor

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