Pseudoephedrine Hydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Pseudoephedrine Hydrochloride
South Africa

Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

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Kikkoman Biochemifa Company advances global health and safety through precision-driven innovation in biotech and food testing.

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Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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Moehs Group, a reference company in the production of pharmaceutical active ingredients.

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Pseudoephedrine Hydrochloride

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

57 API Suppliers, 25 USDMF, 9 CEP/COS, 1 JDMF, 2 EU WC, 22 KDMF, 11 NDC API, 13 Listed Suppliers, $ API Reference Price

57 API Suppliers
25 USDMF
9 CEP/COS
1 JDMF
2 EU WC
22 KDMF
11 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

207 FDF Dossiers, 113 FDA Orange Book, 40 Europe, 6 Canada, 14 South Africa, 34 Listed Dossiers

207 FDF Dossiers
113 FDA Orange Book
40 Europe
6 Canada
14 South Africa
34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG;30MG, CAPSULE;ORAL - 8MG;60MG, TABLET, EXTENDED RELEASE;ORAL - 240MG, TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG, CAPSULE;ORAL - EQ 200MG FREE ACID AND POTASSIUM SALT;30MG, TABLET;ORAL - 2MG;200MG;30MG, TABLET, EXTENDED RELEASE;ORAL - 1.2GM;120MG, TABLET, EXTENDED RELEASE;ORAL - 600MG;60MG, TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG, SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML, SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5ML

TABLET;ORAL - 200MG;30MG
CAPSULE;ORAL - 8MG;60MG
TABLET, EXTENDED RELEASE;ORAL - 240MG
TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG
CAPSULE;ORAL - EQ 200MG FREE ACID AND POTASSIUM SALT;30MG
TABLET;ORAL - 2MG;200MG;30MG
TABLET, EXTENDED RELEASE;ORAL - 1.2GM;120MG
TABLET, EXTENDED RELEASE;ORAL - 600MG;60MG
TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG
SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML
SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 8 Rochem International Inc, 22 SPI Pharma, 15 DKSH, 2 Pharm-RX Chemical, 12 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 12 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 7 Kirsch Pharma, 4 ACG Worldwide, 15 Actylis, 4 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 38 BASF, 1 Bioplus Life Sciences, 3 CD Formulation, 2 Clariant, 12 Corel Pharma Chem, 7 DFE Pharma, 2 Esteem Industries, 2 Finar, 14 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 18 Microlex e.U, 2 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 37 Roquette, 14 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 1 Symrise, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

106 Fillers, Diluents & Binders, 58 Coating Systems & Additives, 53 Direct Compression, 49 Thickeners and Stabilizers, 47 Disintegrants & Superdisintegrants, 42 Granulation, 37 Controlled & Modified Release, 37 Taste Masking, 37 Solubilizers, 34 Topical, 33 Parenteral, 33 Film Formers & Plasticizers, 30 Lubricants & Glidants, 26 Chewable & Orodispersible Aids, 16 Co-Processed Excipients, 12 Emulsifying Agents, 12 Rheology Modifiers, 10 API Stability Enhancers, 9 Empty Capsules, 6 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

106 Fillers, Diluents & Binders
58 Coating Systems & Additives
53 Direct Compression
49 Thickeners and Stabilizers
47 Disintegrants & Superdisintegrants
42 Granulation
37 Controlled & Modified Release
37 Taste Masking
37 Solubilizers
34 Topical
33 Parenteral
33 Film Formers & Plasticizers
30 Lubricants & Glidants
26 Chewable & Orodispersible Aids
16 Co-Processed Excipients
12 Emulsifying Agents
12 Rheology Modifiers
10 API Stability Enhancers
9 Empty Capsules
6 Surfactant & Foaming Agents
5 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 32 News #PharmaBuzz

1 Data Compilation #PharmaFlow
32 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 Regulatory FDF Prices

1 Regulatory FDF Prices

MARKET PLACE

26 APIs

26 APIs

PATENTS & EXCLUSIVITIES

1 US Patents, 7 Health Canada Patents

1 US Patents
7 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM

1 EDQM

$ API Ref.Price (USD/KG) : 53 Xls

Filters

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Filters

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14 All

01 3Pharmacare Limited, Woodmead

02 5Cipla Medpro (Pty) Ltd

03 2Loock Pharmaceuticals (Pty) Ltd

04 1Pfizer Laboratories (Pty) Ltd

05 2Pharmascript Pharmaceuticals Ltd

06 1Wyeth Consumer Healthcare

filter Active Ingredients Reset all filters

14 All

01 2Cathine (pseudoephedrine hydrochloride)

02 4Pseudoephedrine HCI

03 2Pseudoephedrine HCL

04 6Pseudoephedrine HCl

filter Dosage Form Reset all filters

14 All

01 2EFT

02 1INJ

03 2SOL

04 7SYR

05 2TAB

filter Brand Name Reset all filters

14 All

01 1Acuflu P Syrup A/F

02 1Acutussive Adult Expect

03 1Acutussive Paed Expect

04 2Coryx

05 3Coryx Paediatric

06 1Dimetapp Paediatric Elixir

07 1Flusin Expectorant Syrup

08 1Prevenar

09 2Relislim

10 1Sinuclear Cough Syrup

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

ISPE Annual Meeting

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pseudoephedrine HCI

Brand Name : Acuflu P Syrup A/F

Dosage Form : SYR

Dosage Strength : 15mg/5ml

Packaging : 100X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Pharmacare Limited, Woodmead

ISPE Annual Meeting

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pseudoephedrine HCI

Brand Name : Sinuclear Cough Syrup

Dosage Form : SOL

Dosage Strength : 30mg/5ml

Packaging : 100X1mg/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

Pharmacare Limited, Woodmead

ISPE Annual Meeting

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pseudoephedrine HCI

Brand Name : Flusin Expectorant Syrup

Dosage Form : SOL

Dosage Strength : 30mg/5ml

Packaging : 100X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

Digital Content

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04

Cipla Medpro (Pty) Ltd

ISPE Annual Meeting

Not Confirmed

Cipla Medpro (Pty) Ltd

ISPE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pseudoephedrine HCl

Brand Name : Coryx

Dosage Form : EFT

Dosage Strength : 50mg

Packaging : 12X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Cipla Medpro (Pty) Ltd

ISPE Annual Meeting

Not Confirmed

Cipla Medpro (Pty) Ltd

ISPE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Pseudoephedrine HCI

Brand Name : Coryx

Dosage Form : EFT

Dosage Strength : 50mg

Packaging : 24X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Cipla Medpro (Pty) Ltd

ISPE Annual Meeting

Not Confirmed

Cipla Medpro (Pty) Ltd

ISPE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pseudoephedrine HCl

Brand Name : Coryx Paediatric

Dosage Form : SYR

Dosage Strength : 25mg/5 ml

Packaging : 70X1mg/5 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Cipla Medpro (Pty) Ltd

ISPE Annual Meeting

Not Confirmed

Cipla Medpro (Pty) Ltd

ISPE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pseudoephedrine HCl

Brand Name : Coryx Paediatric

Dosage Form : SYR

Dosage Strength : 25mg/5 ml

Packaging : 100X1mg/5 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Cipla Medpro (Pty) Ltd

ISPE Annual Meeting

Not Confirmed

Cipla Medpro (Pty) Ltd

ISPE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pseudoephedrine HCl

Brand Name : Coryx Paediatric

Dosage Form : SYR

Dosage Strength : 25mg/5 ml

Packaging : 140X1mg/5 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Loock Pharmaceuticals (Pty) Ltd

ISPE Annual Meeting

Not Confirmed

Loock Pharmaceuticals (Pty) Ltd

ISPE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Cathine (pseudoephedrine hydrochloride)

Brand Name : Relislim

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Loock Pharmaceuticals (Pty) Ltd

ISPE Annual Meeting

Not Confirmed

Loock Pharmaceuticals (Pty) Ltd

ISPE Annual Meeting

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 : Originator

Registration Country : South Africa

Cathine (pseudoephedrine hydrochloride)

Brand Name : Relislim

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 90X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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