Citric Acid | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Citric Acid
South Africa

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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xyz-pharma-m-2024-10-07

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Citric Acid

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

12 API Suppliers, 2 USDMF, 1 CEP/COS, 4 JDMF, 2 NDC API, 6 Listed Suppliers, $ API Reference Price

12 API Suppliers
2 USDMF
1 CEP/COS
4 JDMF
2 NDC API
6 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

40 Drugs in Development

40 Drugs in Development

FINISHED DOSAGE FORMULATIONS

82 FDF Dossiers, 9 FDA Orange Book, 15 Europe, 49 Canada, 7 South Africa, 2 Listed Dossiers

82 FDF Dossiers
9 FDA Orange Book
15 Europe
49 Canada
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- 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 12GM/BOT;3.5GM/BOT;10MG/BOT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- 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

10 Rochem International Inc, 15 SPI Pharma, 2 Seqens, 10 DKSH, 2 Pharm-RX Chemical, 4 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Capital Farma, 4 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 22 BASF, 1 Bioplus Life Sciences, 2 Clariant, 10 Corel Pharma Chem, 2 DFE Pharma, 2 Finar, 8 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 19 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 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 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

61 Fillers, Diluents & Binders, 54 Coating Systems & Additives, 33 Thickeners and Stabilizers, 31 Controlled & Modified Release, 27 Direct Compression, 25 Taste Masking, 23 Topical, 22 Parenteral, 21 Film Formers & Plasticizers, 17 Granulation, 17 Solubilizers, 17 Lubricants & Glidants, 14 Chewable & Orodispersible Aids, 14 Co-Processed Excipients, 9 Empty Capsules, 9 Disintegrants & Superdisintegrants, 7 API Stability Enhancers, 6 Emulsifying Agents, 5 Rheology Modifiers, 4 Surfactant & Foaming Agents, 4 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

61 Fillers, Diluents & Binders
54 Coating Systems & Additives
33 Thickeners and Stabilizers
31 Controlled & Modified Release
27 Direct Compression
25 Taste Masking
23 Topical
22 Parenteral
21 Film Formers & Plasticizers
17 Granulation
17 Solubilizers
17 Lubricants & Glidants
14 Chewable & Orodispersible Aids
14 Co-Processed Excipients
9 Empty Capsules
9 Disintegrants & Superdisintegrants
7 API Stability Enhancers
6 Emulsifying Agents
5 Rheology Modifiers
4 Surfactant & Foaming Agents
4 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 20 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
20 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 14 Finished Drug Prices

1 US Medicaid Prescriptions
14 Finished Drug Prices

MARKET PLACE

28 APIs, 1 FDF Dossiers, 13 EXCIPIENTS, 1 Intermediates

28 APIs
1 FDF Dossiers
13 EXCIPIENTS
1 Intermediates

PATENTS & EXCLUSIVITIES

10 US Patents

10 US Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 4 USP, 1 Others

1 EDQM
4 USP
1 Others

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

Filters

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7 All

01 2Pharmacare Limited, Woodmead

02 2Adcock Ingram Critical Care (Pty) Ltd

03 2Alliance Pharmaceuticals

04 1Ferring (Pty) Ltd

filter Active Ingredients Reset all filters

7 All

01 4Citric Acid

02 1Citric Acid (Anhydrous)

03 2Citric acid

filter Dosage Form Reset all filters

7 All

01 1POW

02 2SOL

03 2SUS

04 2SYR

filter Brand Name Reset all filters

7 All

01 1Fenwal Acd Formula 500 Ml

02 1Fenwal Acd Solution Usp Formula A (500 Ml)

03 2Gencit Simplex

04 2Minamino

05 1Picolax

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Citric acid

Brand Name : Minamino

Dosage Form : SYR

Dosage Strength : 20mg/5ml

Packaging : 200X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Pharmacare Limited, Woodmead

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Citric acid

Brand Name : Minamino

Dosage Form : SYR

Dosage Strength : 20mg/5ml

Packaging : 500X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

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Product Web Link

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03

Adcock Ingram Critical Care (Pty) Ltd

Pharma, Lab & Chemical Expo

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Citric Acid

Brand Name : Fenwal Acd Formula 500 Ml

Dosage Form : SOL

Dosage Strength : 730mg/1000ml

Packaging : 500X1mg/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

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04

Adcock Ingram Critical Care (Pty) Ltd

Pharma, Lab & Chemical Expo

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

Pharma, Lab & Chemical Expo

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Citric Acid

Brand Name : Fenwal Acd Solution Usp Formula A (500 Ml)

Dosage Form : SOL

Dosage Strength : 730mg/1000ml

Packaging : 500X18mg/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

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05

Alliance Pharmaceuticals

Pharma, Lab & Chemical Expo

Not Confirmed

Alliance Pharmaceuticals

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Regulatory Info : Generic

Registration Country : South Africa

Citric Acid

Brand Name : Gencit Simplex

Dosage Form : SUS

Dosage Strength : 21mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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06

Alliance Pharmaceuticals

Pharma, Lab & Chemical Expo

Not Confirmed

Alliance Pharmaceuticals

Pharma, Lab & Chemical Expo

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Regulatory Info : Generic

Registration Country : South Africa

Citric Acid

Brand Name : Gencit Simplex

Dosage Form : SUS

Dosage Strength : 21mg

Packaging : 2500X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

07

Ferring (Pty) Ltd

Pharma, Lab & Chemical Expo

Not Confirmed

Ferring (Pty) Ltd

Pharma, Lab & Chemical Expo

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Regulatory Info : Generic

Registration Country : South Africa

Citric Acid (Anhydrous)

Brand Name : Picolax

Dosage Form : POW

Dosage Strength : 12g

Packaging : 2X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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