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Omeprazole

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ACTIVE PHARMA INGREDIENTS

108 API Suppliers, 41 USDMF, 38 CEP/COS, 9 JDMF, 25 EU WC, 24 KDMF, 33 NDC API, 2 VMF, 66 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

24 Intermediate Suppliers

24 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1019 FDF Dossiers, 96 FDA Orange Book, 571 Europe, 11 Canada, 115 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CAPSULE, DELAYED REL PELLETS;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, DELAYED REL PELLETS;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, DELAYED REL PELLETS;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 325MG;40MG, TABLET, DELAYED RELEASE;ORAL - 81MG;40MG, TABLET, ORALLY DISINTEGRATING,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, 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- 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 7 Evonik, 5 Rochem International Inc, 21 SPI Pharma, 15 DKSH, 2 Pharm-RX Chemical, 9 Faran Shimi Pharmaceutical, 10 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 8 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Pramukh Pharmachem, 1 Zeal MediPharma, 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

96 Fillers, Diluents & Binders, 79 Coating Systems & Additives, 48 Controlled & Modified Release, 46 Thickeners and Stabilizers, 45 Disintegrants & Superdisintegrants, 42 Solubilizers, 40 Direct Compression, 36 Granulation, 31 Taste Masking, 27 Topical, 27 Lubricants & Glidants, 23 Film Formers & Plasticizers, 22 Chewable & Orodispersible Aids, 20 Parenteral, 19 Co-Processed Excipients, 11 Rheology Modifiers, 10 Emulsifying Agents, 9 Empty Capsules, 7 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

83 News #PharmaBuzz

83 News #PharmaBuzz

GLOBAL SALES INFORMATION

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

MARKET PLACE

63 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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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Sanofi	France	SANYO FINE CO LTD	14969	OMEPRAZOLE	2000-07-31	Inactive	II	N/A
28/03/2025	Metrochem API Private Limited	India	METROCHEM API PRIVATE LTD	34759	OMEPRAZOLE USP	2020-06-03	Active	II	N/A

Omeprazole

Omeprazole

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Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

108 API Suppliers

41 USDMF

38 CEP/COS

9 JDMF

25 EU WC

24 KDMF

33 NDC API

2 VMF

66 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

INTERMEDIATES

24 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1019 FDF Dossiers

96 FDA Orange Book

571 Europe

11 Canada

115 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

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

7 Evonik

5 Rochem International Inc

21 SPI Pharma

15 DKSH

2 Pharm-RX Chemical

9 Faran Shimi Pharmaceutical

10 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

8 Gangwal Healthcare

10 Nanjing Well Pharmaceutical

2 Pfanstiehl

1 Pramukh Pharmachem

1 Zeal MediPharma

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