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Hydromorphone Hydrochloride
Europe

AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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pharmacompass-1-m-2026-01-12

Evonik Health Care is the innovation hub for leading life science companies

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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pharmacompass-2-2026-02-09

Hydromorphone Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 10 USDMF, 7 CEP/COS, 1 JDMF, 2 KDMF, 16 NDC API, 10 Listed Suppliers, $ API Reference Price

32 API Suppliers
10 USDMF
7 CEP/COS
1 JDMF
2 KDMF
16 NDC API
10 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

16 Drugs in Development

16 Drugs in Development

FINISHED DOSAGE FORMULATIONS

205 FDF Dossiers, 76 FDA Orange Book, 26 Europe, 41 Canada, 37 Australia, 5 South Africa, 20 Listed Dossiers

205 FDF Dossiers
76 FDA Orange Book
26 Europe
41 Canada
37 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- 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 7 Kirsch Pharma, 1 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 26 BASF, 2 CD Formulation, 1 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 2 Ingredion Pharma Solutions, 26 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 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

72 Fillers, Diluents & Binders, 50 Coating Systems & Additives, 37 Direct Compression, 31 Parenteral, 30 Controlled & Modified Release, 29 Granulation, 29 Thickeners and Stabilizers, 28 Solubilizers, 27 Film Formers & Plasticizers, 20 Disintegrants & Superdisintegrants, 20 Taste Masking, 20 Topical, 18 Lubricants & Glidants, 16 Chewable & Orodispersible Aids, 14 Co-Processed Excipients, 8 Emulsifying Agents, 7 API Stability Enhancers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 4 Vegetarian Capsules, 4 Rheology Modifiers, 2 Coloring Agents, 1 Soft Gelatin

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

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 58 News #PharmaBuzz

3 Data Compilation #PharmaFlow
58 News #PharmaBuzz

GLOBAL SALES INFORMATION

17 US Medicaid Prescriptions, 25 Regulatory FDF Prices

17 US Medicaid Prescriptions
25 Regulatory FDF Prices

MARKET PLACE

3 APIs, 2 FDF Dossiers

3 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 1 US Exclusivities

14 US Patents
1 US Exclusivities

REF. STANDARDS & IMPURITIES

2 EDQM, 5 Others

2 EDQM
5 Others

$ API Ref.Price (USD/KG) : 968 Xls

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26 All

01 7Aristo Pharma Gmbh

02 5JANSSEN CILAG SpA

03 4Janssen Cilag Sa

04 4Kalceks As

05 1Mundipharma A/S

06 1Mundipharma Ab

07 4Mundipharma Pharmaceuticals Sl

filter Active Ingredients Reset all filters

26 All

01 1Atropine Sulfate Monohydrate; Hydromorphone Hydrochloride

02 25Hydromorphone Hydrochloride

filter Dosage Form Reset all filters

26 All

01 4Extended-Release Hard Capsule

02 8Extended-Release Tablet

03 2Hard Capsule

04 1Hydromorphone 16Mg 14 Joined' Oral Use Rp

05 1Hydromorphone 32Mg 14 Joined' Oral Use Rp

06 1Hydromorphone 4Mg 14 Joined' Oral Use Rp

07 1Hydromorphone 64Mg 14 Joined' Oral Use Rp

08 1Hydromorphone 8Mg 14 Joined' Oral Use Rp

09 1Injectable Solution

10 5Injection/Infusion Solution

11 1Oral Solution

filter Country Reset all filters

26 All

01 5Denmark

02 5Italy

03 15Spain

04 1Sweden

filter Brand Name Reset all filters

26 All

01 5Edunix

02 2Hidromorfona Aristo

03 4Hydromorphonhydrochlorid "Kalceks"

04 4Jurisdictor

05 5Jurnista

06 1Palladon

07 1Palladon Comp

08 4Palladone Continus

List of Suppliers

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01

Aristo Pharma Gmbh

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Aristo Pharma Gmbh

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Regulatory Info : Authorized

Registration Country : Spain

Hydromorphone Hydrochloride

Brand Name : Edunix

Dosage Form : Extended-Release Tablet

Dosage Strength : 16MG

Packaging :

Approval Date : 15-10-2015

Application Number : 79781

Regulatory Info : Authorized

Registration Country : Spain

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02

Aristo Pharma Gmbh

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Aristo Pharma Gmbh

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Regulatory Info : Authorized

Registration Country : Spain

Hydromorphone Hydrochloride

Brand Name : Edunix

Dosage Form : Extended-Release Tablet

Dosage Strength : 32MG

Packaging :

Approval Date : 15-10-2015

Application Number : 79782

Regulatory Info : Authorized

Registration Country : Spain

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03

Aristo Pharma Gmbh

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Aristo Pharma Gmbh

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Regulatory Info : Authorized

Registration Country : Spain

Hydromorphone Hydrochloride

Brand Name : Hidromorfona Aristo

Dosage Form : Hard Capsule

Dosage Strength : 1.3MG

Packaging :

Approval Date : 15-09-2021

Application Number : 86200

Regulatory Info : Authorized

Registration Country : Spain

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04

Aristo Pharma Gmbh

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Aristo Pharma Gmbh

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Regulatory Info : Authorized

Registration Country : Spain

Hydromorphone Hydrochloride

Brand Name : Hidromorfona Aristo

Dosage Form : Hard Capsule

Dosage Strength : 2.6MG

Packaging :

Approval Date : 15-09-2021

Application Number : 86201

Regulatory Info : Authorized

Registration Country : Spain

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Aristo Pharma Gmbh

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Aristo Pharma Gmbh

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Regulatory Info : Authorized

Registration Country : Spain

Hydromorphone Hydrochloride

Brand Name : Edunix

Dosage Form : Extended-Release Tablet

Dosage Strength : 8MG

Packaging :

Approval Date : 15-10-2015

Application Number : 79784

Regulatory Info : Authorized

Registration Country : Spain

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06

Aristo Pharma Gmbh

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Aristo Pharma Gmbh

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Regulatory Info : Authorized

Registration Country : Spain

Hydromorphone Hydrochloride

Brand Name : Edunix

Dosage Form : Oral Solution

Dosage Strength : 2.6MG

Packaging :

Approval Date : 14-04-2025

Application Number : 90236

Regulatory Info : Authorized

Registration Country : Spain

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07

Aristo Pharma Gmbh

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Aristo Pharma Gmbh

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Regulatory Info : Authorized

Registration Country : Spain

Hydromorphone Hydrochloride

Brand Name : Edunix

Dosage Form : Extended-Release Tablet

Dosage Strength : 4MG

Packaging :

Approval Date : 15-10-2015

Application Number : 79783

Regulatory Info : Authorized

Registration Country : Spain

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08

Janssen Cilag Sa

ASPEN

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Janssen Cilag Sa

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Regulatory Info : Cancelled

Registration Country : Spain

Hydromorphone Hydrochloride

Brand Name : Jurisdictor

Dosage Form : Extended-Release Tablet

Dosage Strength : 8MG

Packaging :

Approval Date : 05-09-2006

Application Number : 68018

Regulatory Info : Cancelled

Registration Country : Spain

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09

Janssen Cilag Sa

ASPEN

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Janssen Cilag Sa

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Regulatory Info : Cancelled

Registration Country : Spain

Hydromorphone Hydrochloride

Brand Name : Jurisdictor

Dosage Form : Extended-Release Tablet

Dosage Strength : 4MG

Packaging :

Approval Date : 02-04-2008

Application Number : 69710

Regulatory Info : Cancelled

Registration Country : Spain

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10

Janssen Cilag Sa

ASPEN

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Janssen Cilag Sa

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Regulatory Info : Cancelled

Registration Country : Spain

Hydromorphone Hydrochloride

Brand Name : Jurisdictor

Dosage Form : Extended-Release Tablet

Dosage Strength : 16MG

Packaging :

Approval Date : 06-09-2006

Application Number : 68019

Regulatory Info : Cancelled

Registration Country : Spain

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