Adrenaline/Epinephrine | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Adrenaline/Epinephrine
South Africa

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Adrenaline/Epinephrine

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

40 API Suppliers, 14 USDMF, 4 CEP/COS, 2 JDMF, 5 EU WC, 21 NDC API, 15 Listed Suppliers, $ API Reference Price

40 API Suppliers
14 USDMF
4 CEP/COS
2 JDMF
5 EU WC
21 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

138 Drugs in Development

138 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

288 FDF Dossiers, 97 FDA Orange Book, 121 Europe, 17 Canada, 20 Australia, 15 South Africa, 18 Listed Dossiers

288 FDF Dossiers
97 FDA Orange Book
121 Europe
17 Canada
20 Australia
15 South Africa
18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - 0.15MG/DELIVERY, INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - 0.3MG/DELIVERY, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.15MG/DELIVERY, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.1MG/DELIVERY, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.3MG/DELIVERY, SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - EQ 1MG BASE/ML (EQ 1MG BASE/ML), SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - EQ 30MG BASE/30ML (EQ 1MG BASE/ML), SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - 10MG/10ML (1MG/ML), SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS - 1MG/ML (1MG/ML), SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - 30MG/30ML (1MG/ML), SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.15MG/0.3ML (0.15MG/0.3ML), SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.3MG/0.3ML (0.3MG/0.3ML), INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.15MG/DELIVERY, INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.3MG/DELIVERY, INJECTABLE;INJECTION - 0.005MG/ML;0.5%, INJECTABLE;INJECTION - 0.005MG/ML;1%, INJECTABLE;INJECTION - 0.005MG/ML;1.5%, INJECTABLE;INJECTION - 0.005MG/ML;2%, INJECTABLE;INJECTION - 0.01MG/ML;1%, INJECTABLE;INJECTION - 0.01MG/ML;2%, INJECTABLE;INJECTION - 0.02MG/ML;2%, INJECTABLE;INJECTION - 0.5%, INJECTABLE;INJECTION - 1%, INJECTABLE;INJECTION - 1.5%, INJECTABLE;INJECTION - 2%

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - 0.15MG/DELIVERY
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - 0.3MG/DELIVERY
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.15MG/DELIVERY
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.1MG/DELIVERY
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.3MG/DELIVERY
SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - EQ 1MG BASE/ML (EQ 1MG BASE/ML)
SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - EQ 30MG BASE/30ML (EQ 1MG BASE/ML)
SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - 10MG/10ML (1MG/ML)
SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS - 1MG/ML (1MG/ML)
SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - 30MG/30ML (1MG/ML)
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.15MG/0.3ML (0.15MG/0.3ML)
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.3MG/0.3ML (0.3MG/0.3ML)
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.15MG/DELIVERY
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.3MG/DELIVERY
INJECTABLE;INJECTION - 0.005MG/ML;0.5%
INJECTABLE;INJECTION - 0.005MG/ML;1%
INJECTABLE;INJECTION - 0.005MG/ML;1.5%
INJECTABLE;INJECTION - 0.005MG/ML;2%
INJECTABLE;INJECTION - 0.01MG/ML;1%
INJECTABLE;INJECTION - 0.01MG/ML;2%
INJECTABLE;INJECTION - 0.02MG/ML;2%
INJECTABLE;INJECTION - 0.5%
INJECTABLE;INJECTION - 1%
INJECTABLE;INJECTION - 1.5%
INJECTABLE;INJECTION - 2%

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 9 Rochem International Inc, 19 SPI Pharma, 1 DKSH, 1 Pharm-RX Chemical, 6 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Capital Farma, 6 Kirsch Pharma, 11 Actylis, 2 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 9 BASF, 8 Beneo, 1 Bioplus Life Sciences, 1 CD Formulation, 2 DFE Pharma, 7 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 2 Ideal Cures, 3 Ingredion Pharma Solutions, 3 Kerry, 1 Keval Exports, 13 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 33 Roquette, 2 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 8 Sigachi Industries, 3 Silverline Chemicals, 1 Symrise, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem, 3 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

68 Fillers, Diluents & Binders, 40 Taste Masking, 32 Direct Compression, 25 Thickeners and Stabilizers, 24 Chewable & Orodispersible Aids, 23 Disintegrants & Superdisintegrants, 19 Parenteral, 18 Coating Systems & Additives, 17 Film Formers & Plasticizers, 16 Granulation, 14 Lubricants & Glidants, 12 Co-Processed Excipients, 8 Controlled & Modified Release, 8 Solubilizers, 4 Topical, 4 Emulsifying Agents, 2 API Stability Enhancers, 1 Soft Gelatin, 1 Rheology Modifiers

68 Fillers, Diluents & Binders
40 Taste Masking
32 Direct Compression
25 Thickeners and Stabilizers
24 Chewable & Orodispersible Aids
23 Disintegrants & Superdisintegrants
19 Parenteral
18 Coating Systems & Additives
17 Film Formers & Plasticizers
16 Granulation
14 Lubricants & Glidants
12 Co-Processed Excipients
8 Controlled & Modified Release
8 Solubilizers
4 Topical
4 Emulsifying Agents
2 API Stability Enhancers
1 Soft Gelatin
1 Rheology Modifiers

DIGITAL CONTENT

4 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 494 News #PharmaBuzz

4 Data Compilation #PharmaFlow
1 Stock Recap #PipelineProspector
494 News #PharmaBuzz

GLOBAL SALES INFORMATION

11 US Medicaid Prescriptions, 105 Regulatory FDF Prices, 21 Annual Reports

11 US Medicaid Prescriptions
105 Regulatory FDF Prices
21 Annual Reports

MARKET PLACE

22 APIs, 26 FDF Dossiers

22 APIs
26 FDF Dossiers

PATENTS & EXCLUSIVITIES

88 US Patents, 2 US Exclusivities

88 US Patents
2 US Exclusivities

REF. STANDARDS & IMPURITIES

3 USP, 6 Others

3 USP
6 Others

$ API Ref.Price (USD/KG) : 16,720 Xls

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15 All

01 33M South Africa (Pty) Ltd

02 2Adcock Ingram Limited

03 1Fresenius Kabi Manufacturing SA (Pty) Ltd

04 3Henry Schein Dental Warehouse (Pty) Ltd

05 5Mylan (Pty) Ltd

06 1Pharma-Q Holdings (Pty) Ltd

filter Active Ingredients Reset all filters

15 All

01 11Adrenaline

02 2Adrenaline base

03 2Epinephrine

filter Dosage Form Reset all filters

15 All

01 15INJ

filter Brand Name Reset all filters

15 All

01 1Adrenaline (Epinephrine) 1 mg/1 ml (1:1 000) Fresenius

02 1Adrenotone

03 2Epipen

04 2Epipen Junior Auto-Injector

05 1Lignospan 2%

06 1Macaine HCI 0.5% Injection with Adrenaline 1:200000 (as bitartrate)

07 1Pharma-Q Adrenaline Injection 1mg/ml

08 1Scandonest 2 % Special

09 1Septanest with Adrenaline 1/100,000

10 1Ubistesin

11 1Ubistesin Forte

12 1Xylestesin-A

13 1Xylotox E80-A

List of Suppliers

Product Main Page

01

3M South Africa (Pty) Ltd

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3M South Africa (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Xylestesin-A

Dosage Form : INJ

Dosage Strength : 0.012mg/ml

Packaging : 50X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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02

3M South Africa (Pty) Ltd

ChemOutsourcing

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3M South Africa (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Ubistesin

Dosage Form : INJ

Dosage Strength : 0.01mg/ml

Packaging : 50X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Corporate PDF

03

3M South Africa (Pty) Ltd

ChemOutsourcing

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3M South Africa (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Ubistesin Forte

Dosage Form : INJ

Dosage Strength : 0.01mg/ml

Packaging : 50X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Corporate PDF

04

Adcock Ingram Limited

ChemOutsourcing

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Adcock Ingram Limited

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Xylotox E80-A

Dosage Form : INJ

Dosage Strength : 20mg/ml

Packaging : 1.8X100µg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Adcock Ingram Limited

ChemOutsourcing

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Adcock Ingram Limited

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Epinephrine

Brand Name : Macaine HCI 0.5% Injection with Adrenaline 1:200000 (as bitartrate)

Dosage Form : INJ

Dosage Strength : 5mg/ml

Packaging : 20X10mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Product Web Link

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06

Fresenius Kabi Manufacturing SA (Pty) Lt...

ChemOutsourcing

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Fresenius Kabi Manufacturing SA (Pty) Lt...

ChemOutsourcing

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Adrenaline (Epinephrine) 1 mg/1 ml (1:1 000) Fresenius

Dosage Form : INJ

Dosage Strength : 1mg/ml

Packaging : 1X10mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Mylan (Pty) Ltd

ChemOutsourcing

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Mylan (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Epipen Junior Auto-Injector

Dosage Form : INJ

Dosage Strength : 0.15mg/0.3ml

Packaging : 0.3X2mg/0.3ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Mylan (Pty) Ltd

ChemOutsourcing

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Mylan (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Epipen Junior Auto-Injector

Dosage Form : INJ

Dosage Strength : 0.15mg/0.3ml

Packaging : 0.3X1mg/0.3ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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09

Mylan (Pty) Ltd

ChemOutsourcing

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Mylan (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Epipen

Dosage Form : INJ

Dosage Strength : 1mg/ml

Packaging : 1X2mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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10

Mylan (Pty) Ltd

ChemOutsourcing

Not Confirmed

Mylan (Pty) Ltd

ChemOutsourcing

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Epipen

Dosage Form : INJ

Dosage Strength : 1mg/ml

Packaging : 1X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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