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

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Naloxone Hydrochloride
South Africa

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Naloxone Hydrochloride

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Naloxone Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

28 API Suppliers, 13 USDMF, 12 CEP/COS, 1 JDMF, 2 EU WC, 2 KDMF, 19 NDC API, 18 Listed Suppliers, $ API Reference Price

28 API Suppliers
13 USDMF
12 CEP/COS
1 JDMF
2 EU WC
2 KDMF
19 NDC API
18 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

55 Drugs in Development

55 Drugs in Development

INTERMEDIATES

10 Intermediates Suppliers

10 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

312 FDF Dossiers, 161 FDA Orange Book, 83 Europe, 13 Canada, 16 Australia, 7 South Africa, 32 Listed Dossiers

312 FDF Dossiers
161 FDA Orange Book
83 Europe
13 Canada
16 Australia
7 South Africa
32 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE, FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE, FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.4MG/0.4ML (0.4MG/0.4ML), TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML), FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE, FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE, FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE, FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE

FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE
FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE
FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.4MG/0.4ML (0.4MG/0.4ML)
TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML)
FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE
FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE
FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE
FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE

RELATED EXCIPIENT COMPANIES

1 Minakem, 4 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 1 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 10 Actylis, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 16 BASF, 1 Bioplus Life Sciences, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

83 Fillers, Diluents & Binders, 45 Coating Systems & Additives, 40 Direct Compression, 25 Taste Masking, 25 Controlled & Modified Release, 24 Thickeners and Stabilizers, 23 Granulation, 22 Disintegrants & Superdisintegrants, 20 Co-Processed Excipients, 20 Lubricants & Glidants, 18 Chewable & Orodispersible Aids, 11 Parenteral, 8 Solubilizers, 8 Topical, 7 Film Formers & Plasticizers, 6 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Emulsifying Agents, 3 Rheology Modifiers, 2 Coloring Agents, 1 Surfactant & Foaming Agents

83 Fillers, Diluents & Binders
45 Coating Systems & Additives
40 Direct Compression
25 Taste Masking
25 Controlled & Modified Release
24 Thickeners and Stabilizers
23 Granulation
22 Disintegrants & Superdisintegrants
20 Co-Processed Excipients
20 Lubricants & Glidants
18 Chewable & Orodispersible Aids
11 Parenteral
8 Solubilizers
8 Topical
7 Film Formers & Plasticizers
6 API Stability Enhancers
5 Empty Capsules
4 Vegetarian Capsules
4 Emulsifying Agents
3 Rheology Modifiers
2 Coloring Agents
1 Surfactant & Foaming Agents

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 237 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
237 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 76 Finished Drug Prices

2 US Medicaid Prescriptions
76 Finished Drug Prices

MARKET PLACE

17 APIs, 10 FDF Dossiers

17 APIs
10 FDF Dossiers

PATENTS & EXCLUSIVITIES

183 US Patents, 3 US Exclusivities

183 US Patents
3 US Exclusivities

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 5 Others

3 EDQM
1 USP
5 Others

$ API Ref.Price (USD/KG) : 10,350 Xls

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01 2Fresenius Kabi Manufacturing SA (Pty) Ltd

02 4Mundipharma (Pty) Ltd

03 1Pharma-Q Holdings (Pty) Ltd

filter Active Ingredients Reset all filters

7 All

01 1Naloxone

02 2Naloxone Hcl

03 4Naloxone Hydrochloride

filter Dosage Form Reset all filters

7 All

01 3INJ

02 4SRT

filter Brand Name Reset all filters

7 All

01 1Naloxone Hcl Fresenius 0.4Mg/1Ml

02 1Naloxone Hcl Neonatal Fresenius 0.02mg/1ml

03 1Pharma-Q Naloxone HCL Injection 0,4mg/ml

04 1Targinact 10 mg / 5 mg

05 1Targinact 20 mg / 10 mg

06 1Targinact 40 mg / 20 mg

07 1Targinact 5 mg / 2.5 mg

Veranova Naloxone hydrochloride

List of Suppliers

Product Main Page

01

Fresenius Kabi Manufacturing SA (Pty) Lt...

Pharma, Lab & Chemical Expo

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Fresenius Kabi Manufacturing SA (Pty) Lt...

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Regulatory Info : Generic

Registration Country : South Africa

Naloxone Hcl

Brand Name : Naloxone Hcl Neonatal Fresenius 0.02mg/1ml

Dosage Form : INJ

Dosage Strength : 20mg/2ml

Packaging : 2X10mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Fresenius Kabi Manufacturing SA (Pty) Lt...

Pharma, Lab & Chemical Expo

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Fresenius Kabi Manufacturing SA (Pty) Lt...

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Regulatory Info : Generic

Registration Country : South Africa

Naloxone Hcl

Brand Name : Naloxone Hcl Fresenius 0.4Mg/1Ml

Dosage Form : INJ

Dosage Strength : 100mcg/2ml

Packaging : 1X10mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Mundipharma (Pty) Ltd

Pharma, Lab & Chemical Expo

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Mundipharma (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Naloxone Hydrochloride

Brand Name : Targinact 5 mg / 2.5 mg

Dosage Form : SRT

Dosage Strength : 2.5mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

Mundipharma (Pty) Ltd

Pharma, Lab & Chemical Expo

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Mundipharma (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Naloxone Hydrochloride

Brand Name : Targinact 10 mg / 5 mg

Dosage Form : SRT

Dosage Strength : 5mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Mundipharma (Pty) Ltd

Pharma, Lab & Chemical Expo

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Mundipharma (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Naloxone Hydrochloride

Brand Name : Targinact 20 mg / 10 mg

Dosage Form : SRT

Dosage Strength : 10mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

Mundipharma (Pty) Ltd

Pharma, Lab & Chemical Expo

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Mundipharma (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Naloxone Hydrochloride

Brand Name : Targinact 40 mg / 20 mg

Dosage Form : SRT

Dosage Strength : 20mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Pharma-Q Holdings (Pty) Ltd

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Pharma-Q Holdings (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Pharma-Q Naloxone HCL Injection 0,4mg/ml

Dosage Form : INJ

Dosage Strength : 5mg/2ml

Packaging : 10X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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