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

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Epinephrine
South Africa

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Epinephrine

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 15 USDMF, 5 CEP/COS, 3 JDMF, 3 EU WC, 21 NDC API, 15 Listed Suppliers, $ API Reference Price

27 API Suppliers
15 USDMF
5 CEP/COS
3 JDMF
3 EU WC
21 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

80 Drugs in Development

80 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

282 FDF Dossiers, 92 FDA Orange Book, 121 Europe, 19 Canada, 20 Australia, 15 South Africa, 15 Listed Dossiers

282 FDF Dossiers
92 FDA Orange Book
121 Europe
19 Canada
20 Australia
15 South Africa
15 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, 4 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Capital Farma, 11 Actylis, 2 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 8 Beneo, 1 Bioplus Life Sciences, 2 DFE Pharma, 7 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 2 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 8 Kerry, 13 Microlex e.U, 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, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem, 3 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

69 Fillers, Diluents & Binders, 39 Taste Masking, 32 Direct Compression, 22 Chewable & Orodispersible Aids, 22 Thickeners and Stabilizers, 22 Disintegrants & Superdisintegrants, 20 Coating Systems & Additives, 18 Film Formers & Plasticizers, 16 Granulation, 14 Lubricants & Glidants, 14 Parenteral, 13 Co-Processed Excipients, 10 Controlled & Modified Release, 8 Solubilizers, 4 Emulsifying Agents, 3 Topical, 2 API Stability Enhancers, 1 Soft Gelatin, 1 Rheology Modifiers

69 Fillers, Diluents & Binders
39 Taste Masking
32 Direct Compression
22 Chewable & Orodispersible Aids
22 Thickeners and Stabilizers
22 Disintegrants & Superdisintegrants
20 Coating Systems & Additives
18 Film Formers & Plasticizers
16 Granulation
14 Lubricants & Glidants
14 Parenteral
13 Co-Processed Excipients
10 Controlled & Modified Release
8 Solubilizers
4 Emulsifying Agents
3 Topical
2 API Stability Enhancers
1 Soft Gelatin
1 Rheology Modifiers

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 471 NEWS #PharmaBuzz

4 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
471 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 105 Finished Drug Prices, 19 Annual Reports

4 US Medicaid Prescriptions
105 Finished Drug Prices
19 Annual Reports

MARKET PLACE

21 APIs, 26 FDF Dossiers

21 APIs
26 FDF Dossiers

PATENTS & EXCLUSIVITIES

99 US Patents

99 US Patents

REF. STANDARDS & IMPURITIES

1 USP, 3 Others

1 USP
3 Others

$ API Ref.Price (USD/KG) : 17,014 Xls

Filters

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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 Fresenius 1 mg/1 ml (1:1 000)

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

BioAsia

Not Confirmed

3M South Africa (Pty) Ltd

BioAsia

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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

Portfolio PDF

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Digital Content

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02

3M South Africa (Pty) Ltd

BioAsia

Not Confirmed

3M South Africa (Pty) Ltd

BioAsia

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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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03

3M South Africa (Pty) Ltd

BioAsia

Not Confirmed

3M South Africa (Pty) Ltd

BioAsia

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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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04

Adcock Ingram Limited

BioAsia

Not Confirmed

Adcock Ingram Limited

BioAsia

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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

BioAsia

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Adcock Ingram Limited

BioAsia

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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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06

Fresenius Kabi Manufacturing SA (Pty) Lt...

BioAsia

Not Confirmed

Fresenius Kabi Manufacturing SA (Pty) Lt...

BioAsia

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

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

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

BioAsia

Not Confirmed

Mylan (Pty) Ltd

BioAsia

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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

BioAsia

Not Confirmed

Mylan (Pty) Ltd

BioAsia

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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

BioAsia

Not Confirmed

Mylan (Pty) Ltd

BioAsia

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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

BioAsia

Not Confirmed

Mylan (Pty) Ltd

BioAsia

Not Confirmed

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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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