Aneurine hydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Aneurine Hydrochloride
South Africa

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Aneurine hydrochloride

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 6 USDMF, 5 CEP/COS, 3 JDMF, 2 EU WC, 10 NDC API, 16 Listed Suppliers, $ API Reference Price

30 API Suppliers
6 USDMF
5 CEP/COS
3 JDMF
2 EU WC
10 NDC API
16 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

82 FDF Dossiers, 34 FDA Orange Book, 33 Europe, 8 South Africa, 7 Listed Dossiers

82 FDF Dossiers
34 FDA Orange Book
33 Europe
8 South Africa
7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL, SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML, SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML, INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL, INJECTABLE;INJECTION - 100MG/ML, INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL
SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML
SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML
INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL
INJECTABLE;INJECTION - 100MG/ML
INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 7 Rochem International Inc, 21 SPI Pharma, 23 DKSH, 1 Pharm-RX Chemical, 7 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 2 Kewpie Corporation, 10 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 9 Kirsch Pharma, 4 ACG Worldwide, 13 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 27 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 10 Corel Pharma Chem, 5 DFE Pharma, 1 Esteem Industries, 3 Finar, 13 Gangwal Chemicals, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 22 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 10 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 37 Roquette, 15 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

94 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 50 Thickeners and Stabilizers, 41 Direct Compression, 39 Parenteral, 35 Solubilizers, 35 Disintegrants & Superdisintegrants, 30 Granulation, 30 Taste Masking, 27 Topical, 24 Controlled & Modified Release, 24 Chewable & Orodispersible Aids, 22 Film Formers & Plasticizers, 19 Lubricants & Glidants, 16 Emulsifying Agents, 15 Co-Processed Excipients, 13 Rheology Modifiers, 9 Empty Capsules, 8 API Stability Enhancers, 7 Surfactant & Foaming Agents, 4 Vegetarian Capsules, 4 Coloring Agents, 1 Soft Gelatin

94 Fillers, Diluents & Binders
53 Coating Systems & Additives
50 Thickeners and Stabilizers
41 Direct Compression
39 Parenteral
35 Solubilizers
35 Disintegrants & Superdisintegrants
30 Granulation
30 Taste Masking
27 Topical
24 Controlled & Modified Release
24 Chewable & Orodispersible Aids
22 Film Formers & Plasticizers
19 Lubricants & Glidants
16 Emulsifying Agents
15 Co-Processed Excipients
13 Rheology Modifiers
9 Empty Capsules
8 API Stability Enhancers
7 Surfactant & Foaming Agents
4 Vegetarian Capsules
4 Coloring Agents
1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 10 News #PharmaBuzz

1 Data Compilation #PharmaFlow
10 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 3 Regulatory FDF Prices

1 US Medicaid Prescriptions
3 Regulatory FDF Prices

MARKET PLACE

34 APIs, 4 FDF Dossiers, 1 Intermediates

34 APIs
4 FDF Dossiers
1 Intermediates

REF. STANDARDS & IMPURITIES

2 EDQM

2 EDQM

ANALYTICAL

1 Analytical Methods

1 Analytical Methods

$ API Ref.Price (USD/KG) : 33 Xls

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01 1Fresenius Kabi SA (Pty) Ltd

02 7Fresenius Kabi South Africa (Pty) Ltd

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01 8Thiamine HCI

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02 7TPN

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01 1ITN5501XA

02 1ITN8801A

03 2ITN8801XA

04 1ITN8807XA

05 1ITN8811A

06 1ITNBABY105

07 1Intramed Dextrose 20%/500ml

Thiamine Hydrochloride

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01

Fresenius Kabi SA (Pty) Ltd

The MedTech Conference

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Fresenius Kabi SA (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Thiamine HCI

Brand Name : Intramed Dextrose 20%/500ml

Dosage Form : INF

Dosage Strength : 100g

Packaging : 500X18g

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Regulatory Info : Originator

Registration Country : South Africa

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Fresenius Kabi South Africa (Pty) Ltd

The MedTech Conference

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Fresenius Kabi South Africa (Pty) Ltd

The MedTech Conference

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Regulatory Info : Originator

Registration Country : South Africa

Thiamine HCI

Brand Name : ITN5501XA

Dosage Form : TPN

Dosage Strength : 50umol

Packaging : 2120X1g

Approval Date :

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Regulatory Info : Originator

Registration Country : South Africa

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03

Fresenius Kabi South Africa (Pty) Ltd

The MedTech Conference

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Fresenius Kabi South Africa (Pty) Ltd

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Registration Country : South Africa

Thiamine HCI

Brand Name : ITN8801A

Dosage Form : TPN

Dosage Strength : 1umol

Packaging : 2640X1g

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Registration Country : South Africa

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Fresenius Kabi South Africa (Pty) Ltd

The MedTech Conference

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Fresenius Kabi South Africa (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Thiamine HCI

Brand Name : ITN8801XA

Dosage Form : TPN

Dosage Strength : 1umol

Packaging : 2420X1g

Approval Date :

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Regulatory Info : Originator

Registration Country : South Africa

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05

Fresenius Kabi South Africa (Pty) Ltd

The MedTech Conference

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Fresenius Kabi South Africa (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Thiamine HCI

Brand Name : ITN8801XA

Dosage Form : TPN

Dosage Strength : 1umol

Packaging : 2420X1g

Approval Date :

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Regulatory Info : Originator

Registration Country : South Africa

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Fresenius Kabi South Africa (Pty) Ltd

The MedTech Conference

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Fresenius Kabi South Africa (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Thiamine HCI

Brand Name : ITN8807XA

Dosage Form : TPN

Dosage Strength : 1umol

Packaging : 2270X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Fresenius Kabi South Africa (Pty) Ltd

The MedTech Conference

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

The MedTech Conference

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Regulatory Info : Originator

Registration Country : South Africa

Thiamine HCI

Brand Name : ITN8811A

Dosage Form : TPN

Dosage Strength : 1umol

Packaging : 1590X1g

Approval Date :

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Regulatory Info : Originator

Registration Country : South Africa

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08

Fresenius Kabi South Africa (Pty) Ltd

The MedTech Conference

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

The MedTech Conference

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Regulatory Info : Originator

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Thiamine HCI

Brand Name : ITNBABY105

Dosage Form : TPN

Dosage Strength : 2umol

Packaging : 150X1g

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Regulatory Info : Originator

Registration Country : South Africa

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