Naloxone Hydrochloride Dihydrate | Australian Register of Therapeutic Goods | Australia | PharmaCompass.com

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Naloxone Hydrochloride Dihydrate
Australia

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Naloxone Hydrochloride

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Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.

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pharmacompass-2-m-2025-11-03

Naloxone Hydrochloride Dihydrate

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 14 USDMF, 11 CEP/COS, 1 JDMF, 3 EU WC, 3 KDMF, 19 NDC API, 18 Listed Suppliers, $ API Reference Price

42 API Suppliers
14 USDMF
11 CEP/COS
1 JDMF
3 EU WC
3 KDMF
19 NDC API
18 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

145 Drugs in Development

145 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

558 FDF Dossiers, 167 FDA Orange Book, 278 Europe, 19 Canada, 52 Australia, 11 South Africa, 31 Listed Dossiers

558 FDF Dossiers
167 FDA Orange Book
278 Europe
19 Canada
52 Australia
11 South Africa
31 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TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML), FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE,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, 18 SPI Pharma, 3 DKSH, 1 Pharm-RX Chemical, 3 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 4 Kirsch Pharma, 1 ACG Worldwide, 10 Actylis, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 16 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 7 Gangwal Chemicals, 4 Ideal Cures, 4 Ingredion Pharma Solutions, 24 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 3 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, 9 Sigachi Industries, 3 Silverline Chemicals, 1 Symrise, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

65 Fillers, Diluents & Binders, 40 Coating Systems & Additives, 37 Direct Compression, 28 Granulation, 27 Taste Masking, 26 Thickeners and Stabilizers, 22 Disintegrants & Superdisintegrants, 20 Chewable & Orodispersible Aids, 19 Controlled & Modified Release, 19 Lubricants & Glidants, 14 Co-Processed Excipients, 13 Parenteral, 10 Topical, 9 Solubilizers, 6 Film Formers & Plasticizers, 5 Rheology Modifiers, 5 Empty Capsules, 5 API Stability Enhancers, 4 Emulsifying Agents, 4 Vegetarian Capsules, 2 Coloring Agents, 1 Surfactant & Foaming Agents

65 Fillers, Diluents & Binders
40 Coating Systems & Additives
37 Direct Compression
28 Granulation
27 Taste Masking
26 Thickeners and Stabilizers
22 Disintegrants & Superdisintegrants
20 Chewable & Orodispersible Aids
19 Controlled & Modified Release
19 Lubricants & Glidants
14 Co-Processed Excipients
13 Parenteral
10 Topical
9 Solubilizers
6 Film Formers & Plasticizers
5 Rheology Modifiers
5 Empty Capsules
5 API Stability Enhancers
4 Emulsifying Agents
4 Vegetarian Capsules
2 Coloring Agents
1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 256 News #PharmaBuzz

1 Data Compilation #PharmaFlow
256 News #PharmaBuzz

GLOBAL SALES INFORMATION

37 US Medicaid Prescriptions, 40 Regulatory FDF Prices

37 US Medicaid Prescriptions
40 Regulatory FDF Prices

MARKET PLACE

20 APIs, 10 FDF Dossiers

20 APIs
10 FDF Dossiers

PATENTS & EXCLUSIVITIES

151 US Patents, 2 US Exclusivities, 27 Health Canada Patents

151 US Patents
2 US Exclusivities
27 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 7 Others

3 EDQM
7 Others

$ API Ref.Price (USD/KG) : 8,797 Xls

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52 All

01 18Apotex Pty Ltd

02 2Indivior Pty Ltd

03 3Juno Pharmaceuticals Pty Ltd

04 20Mundipharma Pty Limited

05 3Pfizer Australia Pty Ltd

06 3Phebra Pty Ltd

07 3Southern XP Pty Ltd

filter Active Ingredients Reset all filters

52 All

01 2Buprenorphine + naloxone

02 14Naloxone

03 36Oxycodone + naloxone

filter Dosage Form Reset all filters

52 All

01 2Film

02 36Tablet

03 14Blank

filter Brand Name Reset all filters

52 All

01 2ARX-Oxycodone/Naloxone 10/5

02 2ARX-Oxycodone/Naloxone 15/7.5

03 2ARX-Oxycodone/Naloxone 2.5/1.25

04 2ARX-Oxycodone/Naloxone 20/10

05 2ARX-Oxycodone/Naloxone 30/15

06 2ARX-Oxycodone/Naloxone 40/20

07 2ARX-Oxycodone/Naloxone 5/2.5

08 2ARX-Oxycodone/Naloxone 60/30

09 2ARX-Oxycodone/Naloxone 80/40

10 3NALOXONE SXP

11 1NARCAN

12 3Naloxone Hydrochloride (DBL)

13 3Naloxone Juno

14 2Nyxoid

15 2Prenoxad

16 1Suboxone Film 2/0.5

17 1Suboxone Film 8/2

18 2Targin 10/5mg

19 2Targin 15/7.5mg

20 2Targin 2.5/1.25 mg

21 2Targin 20/10mg

22 2Targin 30/15 mg

23 2Targin 40/20mg

24 2Targin 5/2.5mg

25 2Targin 60/30

26 2Targin 80/40

Veranova Naloxone hydrochloride

List of Suppliers

Product Main Page

01

Apotex Pty Ltd

CPhI India

Not Confirmed

Apotex Pty Ltd

CPhI India

Not Confirmed

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Regulatory Info :

Registration Country : Australia

Oxycodone + naloxone

Brand Name : ARX-Oxycodone/Naloxone 15/7.5

Dosage Form : Tablet

Dosage Strength : 15MG

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

Apotex Pty Ltd

CPhI India

Not Confirmed

Apotex Pty Ltd

CPhI India

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Regulatory Info :

Registration Country : Australia

Oxycodone + naloxone

Brand Name : ARX-Oxycodone/Naloxone 30/15

Dosage Form : Tablet

Dosage Strength : 30MG

Packaging : 28

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Regulatory Info :

Registration Country : Australia

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03

Apotex Pty Ltd

CPhI India

Not Confirmed

Apotex Pty Ltd

CPhI India

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Regulatory Info :

Registration Country : Australia

Oxycodone + naloxone

Brand Name : ARX-Oxycodone/Naloxone 2.5/1.25

Dosage Form : Tablet

Dosage Strength : 2.5MG

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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04

Juno Pharmaceuticals Pty Ltd

CPhI India

Not Confirmed

Juno Pharmaceuticals Pty Ltd

CPhI India

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Registration Country : Australia

Brand Name : Naloxone Juno

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Dosage Strength :

Packaging : 5

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Regulatory Info :

Registration Country : Australia

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05

Juno Pharmaceuticals Pty Ltd

CPhI India

Not Confirmed

Juno Pharmaceuticals Pty Ltd

CPhI India

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Regulatory Info :

Registration Country : Australia

Brand Name : Naloxone Juno

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Dosage Strength :

Packaging : 5

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Regulatory Info :

Registration Country : Australia

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06

Mundipharma Pty Limited

CPhI India

Not Confirmed

Mundipharma Pty Limited

CPhI India

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Regulatory Info :

Registration Country : Australia

Oxycodone + naloxone

Brand Name : Targin 15/7.5mg

Dosage Form : Tablet

Dosage Strength : 15MG

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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07

Mundipharma Pty Limited

CPhI India

Not Confirmed

Mundipharma Pty Limited

CPhI India

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Digital Content

Regulatory Info :

Registration Country : Australia

Oxycodone + naloxone

Brand Name : Targin 30/15 mg

Dosage Form : Tablet

Dosage Strength : 30MG

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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08

Mundipharma Pty Limited

CPhI India

Not Confirmed

Mundipharma Pty Limited

CPhI India

Not Confirmed

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Regulatory Info :

Registration Country : Australia

Oxycodone + naloxone

Brand Name : Targin 2.5/1.25 mg

Dosage Form : Tablet

Dosage Strength : 2.5MG

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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09

Pfizer Australia Pty Ltd

CPhI India

Not Confirmed

Pfizer Australia Pty Ltd

CPhI India

Not Confirmed

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Registration Country : Australia

Brand Name : Naloxone Hydrochloride (DBL)

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Packaging : 5

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Regulatory Info :

Registration Country : Australia

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10

Southern XP Pty Ltd

Country

CPhI India

Not Confirmed

Southern XP Pty Ltd

Country

CPhI India

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Registration Country : Australia

Brand Name : NALOXONE SXP

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Packaging : 5

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Registration Country : Australia

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