Citric Acid Monohydrate | Australian Register of Therapeutic Goods | Australia | PharmaCompass.com

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Citric Acid Monohydrate
Australia

Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

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Smithfield BioScience transforms bioproducts into trusted, life-saving therapies through safe, reliable U.S.-based manufacturing.

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Quotient Sciences- Molecule to Cure. Fast.

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SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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pharmacompass-2-m-2025-11-03

Citric Acid Monohydrate

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 9 USDMF, 1 CEP/COS, 4 JDMF, 2 NDC API, 11 Listed Suppliers, $ API Reference Price

26 API Suppliers
9 USDMF
1 CEP/COS
4 JDMF
2 NDC API
11 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

57 Drugs in Development

57 Drugs in Development

FINISHED DOSAGE FORMULATIONS

120 FDF Dossiers, 9 FDA Orange Book, 41 Europe, 51 Canada, 10 Australia, 7 South Africa, 2 Listed Dossiers

120 FDF Dossiers
9 FDA Orange Book
41 Europe
51 Canada
10 Australia
7 South Africa
2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;IRRIGATION - 6.602GM/100ML;198MG/100ML;3.177GM/100ML, FOR SOLUTION;ORAL - 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 12GM/BOT;3.5GM/BOT;10MG/BOT

SOLUTION;IRRIGATION - 6.602GM/100ML;198MG/100ML;3.177GM/100ML
FOR SOLUTION;ORAL - 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;ORAL - 12GM/BOT;3.5GM/BOT;10MG/BOT

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 10 Rochem International Inc, 16 SPI Pharma, 12 DKSH, 2 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Capital Farma, 7 Kirsch Pharma, 4 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 1 Avesta Pharma, 22 BASF, 1 Bioplus Life Sciences, 2 CD Formulation, 2 Clariant, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Esteem Industries, 2 Finar, 8 Gangwal Chemicals, 5 Ideal Cures, 1 Ingredion Pharma Solutions, 13 Kerry, 1 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 2 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

61 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 38 Thickeners and Stabilizers, 27 Taste Masking, 26 Controlled & Modified Release, 26 Parenteral, 25 Topical, 22 Direct Compression, 20 Film Formers & Plasticizers, 18 Solubilizers, 17 Chewable & Orodispersible Aids, 17 Granulation, 16 Lubricants & Glidants, 12 Disintegrants & Superdisintegrants, 10 Co-Processed Excipients, 9 Empty Capsules, 8 Rheology Modifiers, 7 Emulsifying Agents, 6 API Stability Enhancers, 4 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

61 Fillers, Diluents & Binders
49 Coating Systems & Additives
38 Thickeners and Stabilizers
27 Taste Masking
26 Controlled & Modified Release
26 Parenteral
25 Topical
22 Direct Compression
20 Film Formers & Plasticizers
18 Solubilizers
17 Chewable & Orodispersible Aids
17 Granulation
16 Lubricants & Glidants
12 Disintegrants & Superdisintegrants
10 Co-Processed Excipients
9 Empty Capsules
8 Rheology Modifiers
7 Emulsifying Agents
6 API Stability Enhancers
4 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 22 News #PharmaBuzz

2 Data Compilation #PharmaFlow
22 News #PharmaBuzz

GLOBAL SALES INFORMATION

9 US Medicaid Prescriptions, 10 Regulatory FDF Prices

9 US Medicaid Prescriptions
10 Regulatory FDF Prices

MARKET PLACE

29 APIs, 1 FDF Dossiers, 15 EXCIPIENTS, 1 Intermediates

29 APIs
1 FDF Dossiers
15 EXCIPIENTS
1 Intermediates

PATENTS & EXCLUSIVITIES

10 US Patents

10 US Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 1 USP, 4 Others

1 EDQM
1 USP
4 Others

$ API Ref.Price (USD/KG) : 3 Xls

Filters

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Filters

FILTER :

filter Applicant Reset all filters

10 All

01 1Aspen Pharmacare Australia Pty Limited

02 5AFT Pharmaceuticals (AU) Pty Ltd

03 2Arrotex Pharmaceuticals Pty Ltd

04 1Generic Health Pty Ltd

05 1Pharmacor Pty Limited

filter Active Ingredients Reset all filters

10 All

01 3bicarbonate + citric acid + tartaric acid

02 5citric acid + lauryl sulfoacetate sodium + sorbitol

03 2sodium chloride + potassium chloride + glucose + citric acid

filter Dosage Form Reset all filters

10 All

01 4Enema

02 3Powder

03 2Powder; Powder; Powder; Powder

04 1Blank

filter Brand Name Reset all filters

10 All

01 5Micolette

02 2O.R.S.

03 1Pharmacy Action Cystitis Relief

04 1Trust Cystitis Relief

05 1Ural Sachets

List of Suppliers

Product Main Page

01

Aspen Pharmacare Australia Pty Limited

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Digital Content

Regulatory Info :

Registration Country : Australia

bicarbonate + citric acid + tartaric acid

Brand Name : Ural Sachets

Dosage Form : Powder; Powder; Powder; Powder

Dosage Strength : 1.76G; 0.63G; 0.72G; 0.89G

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Aspen API Comapny Banner

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02

AFT Pharmaceuticals (AU) Pty Ltd

AES

Not Confirmed

AFT Pharmaceuticals (AU) Pty Ltd

AES

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

citric acid + lauryl sulfoacetate sodium + sorbitol

Brand Name : Micolette

Dosage Form : Enema

Dosage Strength : 90MG/1ML

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

AFT Pharmaceuticals (AU) Pty Ltd

AES

Not Confirmed

AFT Pharmaceuticals (AU) Pty Ltd

AES

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info :

Registration Country : Australia

citric acid + lauryl sulfoacetate sodium + sorbitol

Brand Name : Micolette

Dosage Form : Enema

Dosage Strength : 90MG/1ML

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

AFT Pharmaceuticals (AU) Pty Ltd

AES

Not Confirmed

AFT Pharmaceuticals (AU) Pty Ltd

AES

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info :

Registration Country : Australia

citric acid + lauryl sulfoacetate sodium + sorbitol

Brand Name : Micolette

Dosage Form : Enema

Dosage Strength : 90MG/1ML

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

AFT Pharmaceuticals (AU) Pty Ltd

AES

Not Confirmed

AFT Pharmaceuticals (AU) Pty Ltd

AES

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info :

Registration Country : Australia

citric acid + lauryl sulfoacetate sodium + sorbitol

Brand Name : Micolette

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

AFT Pharmaceuticals (AU) Pty Ltd

AES

Not Confirmed

AFT Pharmaceuticals (AU) Pty Ltd

AES

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info :

Registration Country : Australia

citric acid + lauryl sulfoacetate sodium + sorbitol

Brand Name : Micolette

Dosage Form : Enema

Dosage Strength : 90MG/1ML

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Arrotex Pharmaceuticals Pty Ltd

AES

Not Confirmed

Arrotex Pharmaceuticals Pty Ltd

AES

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

sodium chloride + potassium chloride + glucose + citric acid

Brand Name : O.R.S.

Dosage Form : Powder

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Arrotex Pharmaceuticals Pty Ltd

AES

Not Confirmed

Arrotex Pharmaceuticals Pty Ltd

AES

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

sodium chloride + potassium chloride + glucose + citric acid

Brand Name : O.R.S.

Dosage Form : Powder

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Generic Health Pty Ltd

AES

Not Confirmed

Generic Health Pty Ltd

AES

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

bicarbonate + citric acid + tartaric acid

Brand Name : Pharmacy Action Cystitis Relief

Dosage Form : Powder; Powder; Powder; Powder

Dosage Strength : 1.76G; 0.63G; 0.72G; 0.89G

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Pharmacor Pty Limited

AES

Not Confirmed

Pharmacor Pty Limited

AES

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info :

Registration Country : Australia

bicarbonate + citric acid + tartaric acid

Brand Name : Trust Cystitis Relief

Dosage Form : Powder

Dosage Strength : 720MG

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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