HYDROMORPHONE HCL | Australian Register of Therapeutic Goods | Australia | PharmaCompass.com

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HYDROMORPHONE HCL
Australia

SPI Pharma has been solving formulation challenges using superior functional materials.

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As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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jdmfs-not-supported-m-2025-06-23

HYDROMORPHONE HCL

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 11 USDMF, 7 CEP/COS, 1 JDMF, 2 KDMF, 22 NDC API, 9 Listed Suppliers, $ API Reference Price

36 API Suppliers
11 USDMF
7 CEP/COS
1 JDMF
2 KDMF
22 NDC API
9 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

219 FDF Dossiers, 76 FDA Orange Book, 36 Europe, 42 Canada, 40 Australia, 5 South Africa, 20 Listed Dossiers

219 FDF Dossiers
76 FDA Orange Book
36 Europe
42 Canada
40 Australia
5 South Africa
20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 0.2MG/ML, INJECTABLE;INJECTION - 0.5MG/0.5ML, INJECTABLE;INJECTION - 10MG/ML, INJECTABLE;INJECTION - 1MG/ML, INJECTABLE;INJECTION - 2MG/ML, INJECTABLE;INJECTION - 4MG/ML, SOLUTION;ORAL - 5MG/5ML, TABLET;ORAL - 2MG, TABLET;ORAL - 4MG, TABLET;ORAL - 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 0.2MG/ML
INJECTABLE;INJECTION - 0.5MG/0.5ML
INJECTABLE;INJECTION - 10MG/ML
INJECTABLE;INJECTION - 1MG/ML
INJECTABLE;INJECTION - 2MG/ML
INJECTABLE;INJECTION - 4MG/ML
SOLUTION;ORAL - 5MG/5ML
TABLET;ORAL - 2MG
TABLET;ORAL - 4MG
TABLET;ORAL - 8MG
TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Evonik, 2 Rochem International Inc, 15 SPI Pharma, 6 DKSH, 4 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 26 BASF, 1 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 2 Ingredion Pharma Solutions, 39 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 24 Roquette, 12 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

85 Fillers, Diluents & Binders, 54 Coating Systems & Additives, 35 Controlled & Modified Release, 31 Direct Compression, 28 Solubilizers, 27 Film Formers & Plasticizers, 26 Thickeners and Stabilizers, 26 Parenteral, 24 Granulation, 22 Co-Processed Excipients, 20 Disintegrants & Superdisintegrants, 19 Taste Masking, 19 Topical, 18 Lubricants & Glidants, 14 Chewable & Orodispersible Aids, 8 Emulsifying Agents, 7 API Stability Enhancers, 6 Rheology Modifiers, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

85 Fillers, Diluents & Binders
54 Coating Systems & Additives
35 Controlled & Modified Release
31 Direct Compression
28 Solubilizers
27 Film Formers & Plasticizers
26 Thickeners and Stabilizers
26 Parenteral
24 Granulation
22 Co-Processed Excipients
20 Disintegrants & Superdisintegrants
19 Taste Masking
19 Topical
18 Lubricants & Glidants
14 Chewable & Orodispersible Aids
8 Emulsifying Agents
7 API Stability Enhancers
6 Rheology Modifiers
5 Coloring Agents
5 Empty Capsules
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 58 News #PharmaBuzz

2 Data Compilation #PharmaFlow
58 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 46 Regulatory FDF Prices

2 US Medicaid Prescriptions
46 Regulatory FDF Prices

MARKET PLACE

1 APIs, 2 FDF Dossiers

1 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 1 US Exclusivities, 12 Health Canada Patents

14 US Patents
1 US Exclusivities
12 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 3 Others

2 EDQM
3 Others

$ API Ref.Price (USD/KG) : 7,574 Xls

Filters

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40 All

01 3Hameln Pharma

02 1Hameln Pharma GmbH

03 4Juno Pharmaceuticals Pty Ltd

04 3Link Medical Products Pty Ltd

05 10Medsurge Healthcare Pty Ltd

06 19Mundipharma Pty Limited

filter Active Ingredients Reset all filters

40 All

01 40Hydromorphone

filter Dosage Form Reset all filters

40 All

01 16injection

02 15tablet

03 9Blank

filter Brand Name Reset all filters

40 All

01 17Dilaudid

02 2Dilaudid-HP

03 2HYDROMORPHONE JUNO

04 2HYDROMORPHONE JUNO-HP

05 3Hikma

06 3Hydromorphone hydrochloride oral solution, US

07 2Hydromorphone-hameln

08 2Hydromorphone-hameln-HP

09 2MEDSURGE HYDROMORPHONE 2 mg/1 mL

10 2MEDSURGE HYDROMORPHONE HP 10 mg/1 mL

11 3pms-HYDROmorphone

List of Suppliers

Product Main Page

01

Hameln Pharma GmbH

HPAPI Summit

Not Confirmed

Hameln Pharma GmbH

HPAPI Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info :

Registration Country : Australia

Hydromorphone

Brand Name : Hydromorphone-hameln

Dosage Form : injection

Dosage Strength : 2 mg/mL

Packaging : 5

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Juno Pharmaceuticals Pty Ltd

HPAPI Summit

Not Confirmed

Juno Pharmaceuticals Pty Ltd

HPAPI Summit

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Hydromorphone

Brand Name : HYDROMORPHONE JUNO

Dosage Form : injection

Dosage Strength : 2 mg/mL

Packaging : 5

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Medsurge Healthcare Pty Ltd

HPAPI Summit

Not Confirmed

Medsurge Healthcare Pty Ltd

HPAPI Summit

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Hydromorphone

Brand Name : MEDSURGE HYDROMORPHONE 2 mg/1 mL

Dosage Form : injection

Dosage Strength : 2 mg/mL

Packaging : 5

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Mundipharma Pty Limited

HPAPI Summit

Not Confirmed

Mundipharma Pty Limited

HPAPI Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info :

Registration Country : Australia

Hydromorphone

Brand Name : Dilaudid

Dosage Form : tablet

Dosage Strength : 8 mg

Packaging : 20

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Mundipharma Pty Limited

HPAPI Summit

Not Confirmed

Mundipharma Pty Limited

HPAPI Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info :

Registration Country : Australia

Hydromorphone

Brand Name : Dilaudid

Dosage Form : tablet

Dosage Strength : 8 mg

Packaging : 20

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Mundipharma Pty Limited

HPAPI Summit

Not Confirmed

Mundipharma Pty Limited

HPAPI Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Post an Enquiry

Digital Content

Regulatory Info :

Registration Country : Australia

Hydromorphone

Brand Name : Dilaudid

Dosage Form : tablet

Dosage Strength : 4 mg

Packaging : 20

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Mundipharma Pty Limited

HPAPI Summit

Not Confirmed

Mundipharma Pty Limited

HPAPI Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Post an Enquiry

Digital Content

Regulatory Info :

Registration Country : Australia

Hydromorphone

Brand Name : Dilaudid

Dosage Form : tablet

Dosage Strength : 2 mg

Packaging : 20

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Mundipharma Pty Limited

HPAPI Summit

Not Confirmed

Mundipharma Pty Limited

HPAPI Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Post an Enquiry

Digital Content

Regulatory Info :

Registration Country : Australia

Hydromorphone

Brand Name : Dilaudid

Dosage Form : tablet

Dosage Strength : 4 mg

Packaging : 20

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Mundipharma Pty Limited

HPAPI Summit

Not Confirmed

Mundipharma Pty Limited

HPAPI Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info :

Registration Country : Australia

Hydromorphone

Brand Name : Dilaudid

Dosage Form : tablet

Dosage Strength : 2 mg

Packaging : 20

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Mundipharma Pty Limited

HPAPI Summit

Not Confirmed

Mundipharma Pty Limited

HPAPI Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info :

Registration Country : Australia

Hydromorphone

Brand Name : Dilaudid

Dosage Form : tablet

Dosage Strength : 4 mg

Packaging : 20

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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