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

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Naloxone Hydrochloride Dihydrate
South Africa

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Naloxone Hydrochloride Dihydrate

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 13 USDMF, 11 CEP/COS, 1 JDMF, 2 EU WC, 2 KDMF, 19 NDC API, 17 Listed Suppliers, $ API Reference Price

27 API Suppliers
13 USDMF
11 CEP/COS
1 JDMF
2 EU WC
2 KDMF
19 NDC API
17 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

55 Drugs in Development

55 Drugs in Development

INTERMEDIATES

6 Intermediates Suppliers

6 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TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML), FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE,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TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 2 Jai Radhe Sales, 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

85 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 Lubricants & Glidants, 20 Co-Processed Excipients, 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

85 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 Lubricants & Glidants
20 Co-Processed Excipients
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, 235 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
235 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...

American Pharma Summit

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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

Portfolio PDF

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02

Fresenius Kabi Manufacturing SA (Pty) Lt...

American Pharma Summit

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Fresenius Kabi Manufacturing SA (Pty) Lt...

American Pharma Summit

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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

American Pharma Summit

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Mundipharma (Pty) Ltd

American Pharma Summit

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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

American Pharma Summit

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Mundipharma (Pty) Ltd

American Pharma Summit

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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

American Pharma Summit

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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

American Pharma Summit

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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

Country

American Pharma Summit

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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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