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

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Racepinephrine Hydrochloride
South Africa

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Racepinephrine Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

25 API Suppliers, 13 USDMF, 5 CEP/COS, 3 JDMF, 3 EU WC, 21 NDC API, 15 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

71 Drugs in Development

71 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

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

280 FDF Dossiers
90 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

9 Rochem International Inc, 18 SPI Pharma, 1 DKSH, 1 Pharm-RX Chemical, 4 Faran Shimi Pharmaceutical, 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

71 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, 15 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

71 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
15 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

24 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 464 NEWS #PharmaBuzz

24 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
464 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

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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

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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

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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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03

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 : 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

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Adcock Ingram Limited

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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

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Adcock Ingram Limited

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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...

Pharmtech & Ingredients

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Fresenius Kabi Manufacturing SA (Pty) Lt...

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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

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Mylan (Pty) Ltd

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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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Mylan (Pty) Ltd

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Mylan (Pty) Ltd

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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

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Mylan (Pty) Ltd

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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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Mylan (Pty) Ltd

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Mylan (Pty) Ltd

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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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