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

26 API Suppliers, 13 USDMF, 5 CEP/COS, 3 JDMF, 2 EU WC, 21 NDC API, 16 Listed Suppliers, $ API Reference Price

26 API Suppliers
13 USDMF
5 CEP/COS
3 JDMF
2 EU WC
21 NDC API
16 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

67 Drugs in Development

67 Drugs in Development

INTERMEDIATES

3 API Suppliers

3 API Suppliers

FINISHED DOSAGE FORMULATIONS

279 FDF Dossiers, 90 FDA Orange Book, 121 Europe, 19 Canada, 20 Australia, 15 South Africa, 14 Listed Dossiers

279 FDF Dossiers
90 FDA Orange Book
121 Europe
19 Canada
20 Australia
15 South Africa
14 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

9 Rochem International Inc, 18 SPI Pharma, 1 DKSH, 1 Pharm-RX Chemical, 6 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 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

70 Fillers, Diluents & Binders, 38 Taste Masking, 38 Direct Compression, 23 Thickeners and Stabilizers, 21 Chewable & Orodispersible Aids, 20 Coating Systems & Additives, 20 Disintegrants & Superdisintegrants, 18 Film Formers & Plasticizers, 16 Granulation, 15 Lubricants & Glidants, 14 Co-Processed Excipients, 13 Parenteral, 11 Controlled & Modified Release, 6 Solubilizers, 4 Emulsifying Agents, 3 API Stability Enhancers, 2 Topical, 1 Soft Gelatin, 1 Rheology Modifiers

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

DIGITAL CONTENT

23 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 463 NEWS #PharmaBuzz

23 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
463 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

20 APIs, 26 FDF Dossiers

20 APIs
26 FDF Dossiers

PATENTS & EXCLUSIVITIES

94 US Patents

94 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 (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

2024 ACI Convention

Not Confirmed

3M South Africa (Pty) Ltd

2024 ACI Convention

Not Confirmed

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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

Product Web Link

Digital Content

Corporate PDF

02

3M South Africa (Pty) Ltd

2024 ACI Convention

Not Confirmed

3M South Africa (Pty) Ltd

2024 ACI Convention

Not Confirmed

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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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

3M South Africa (Pty) Ltd

2024 ACI Convention

Not Confirmed

3M South Africa (Pty) Ltd

2024 ACI Convention

Not Confirmed

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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

2024 ACI Convention

Not Confirmed

Adcock Ingram Limited

2024 ACI Convention

Not Confirmed

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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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Corporate PDF

05

Adcock Ingram Limited

2024 ACI Convention

Not Confirmed

Adcock Ingram Limited

2024 ACI Convention

Not Confirmed

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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

Portfolio PDF

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Corporate PDF

06

Fresenius Kabi Manufacturing SA (Pty) Lt...

2024 ACI Convention

Not Confirmed

Fresenius Kabi Manufacturing SA (Pty) Lt...

2024 ACI Convention

Not Confirmed

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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

Portfolio PDF

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07

Mylan (Pty) Ltd

2024 ACI Convention

Not Confirmed

Mylan (Pty) Ltd

2024 ACI Convention

Not Confirmed

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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

Portfolio PDF

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08

Mylan (Pty) Ltd

2024 ACI Convention

Not Confirmed

Mylan (Pty) Ltd

2024 ACI Convention

Not Confirmed

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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

Portfolio PDF

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09

Mylan (Pty) Ltd

2024 ACI Convention

Not Confirmed

Mylan (Pty) Ltd

2024 ACI Convention

Not Confirmed

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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

2024 ACI Convention

Not Confirmed

Mylan (Pty) Ltd

2024 ACI Convention

Not Confirmed

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Digital Content

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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