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Hydromorphone Hydrochloride
Europe

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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LEBSA- Your strategic API source for niche molecules.

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Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

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Hydromorphone Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

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

31 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

201 FDF Dossiers, 76 FDA Orange Book, 21 Europe, 42 Canada, 37 Australia, 5 South Africa, 20 Listed Dossiers

201 FDF Dossiers
76 FDA Orange Book
21 Europe
42 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- 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 DKSH, 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, 52 Coating Systems & Additives, 37 Direct Compression, 31 Parenteral, 31 Thickeners and Stabilizers, 30 Controlled & Modified Release, 29 Granulation, 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, 9 Emulsifying Agents, 7 API Stability Enhancers, 6 Rheology Modifiers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

72 Fillers, Diluents & Binders
52 Coating Systems & Additives
37 Direct Compression
31 Parenteral
31 Thickeners and Stabilizers
30 Controlled & Modified Release
29 Granulation
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
9 Emulsifying Agents
7 API Stability Enhancers
6 Rheology Modifiers
5 Empty Capsules
5 Surfactant & Foaming Agents
5 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 58 News #PharmaBuzz

2 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

2 APIs, 2 FDF Dossiers

2 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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filter Applicant Reset all filters

21 All

01 7Aristo Pharma Gmbh

02 5JANSSEN CILAG SpA

03 4Janssen Cilag Sa

04 1Mundipharma Ab

05 4Mundipharma Pharmaceuticals Sl

filter Active Ingredients Reset all filters

21 All

01 1Atropine Sulfate Monohydrate; Hydromorphone Hydrochloride

02 20Hydromorphone Hydrochloride

filter Dosage Form Reset all filters

21 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 1Oral Solution

filter Country Reset all filters

21 All

01 5Italy

02 15Spain

03 1Sweden

filter Brand Name Reset all filters

21 All

01 5Edunix

02 2Hidromorfona Aristo

03 4Jurisdictor

04 5Jurnista

05 1Palladon Comp

06 4Palladone Continus

List of Suppliers

Product Main Page

01

Aristo Pharma Gmbh

IPPE

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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 : 2015-10-15

Application Number : 79781

Regulatory Info : Authorized

Registration Country : Spain

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02

Aristo Pharma Gmbh

IPPE

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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 : 2015-10-15

Application Number : 79782

Regulatory Info : Authorized

Registration Country : Spain

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Product Web Link

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Corporate PDF

03

JANSSEN CILAG SpA

IPPE

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JANSSEN CILAG SpA

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Regulatory Info :

Registration Country : Italy

Hydromorphone Hydrochloride

Brand Name : Jurnista

Dosage Form : Hydromorphone 16Mg 14 Joined' Oral Use Rp

Dosage Strength : 14 CPR 16 mg prolonged release

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

JANSSEN CILAG SpA

IPPE

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JANSSEN CILAG SpA

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Regulatory Info :

Registration Country : Italy

Hydromorphone Hydrochloride

Brand Name : Jurnista

Dosage Form : Hydromorphone 32Mg 14 Joined' Oral Use Rp

Dosage Strength : 14 CPR 32 mg prolonged release

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

JANSSEN CILAG SpA

IPPE

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JANSSEN CILAG SpA

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Regulatory Info :

Registration Country : Italy

Hydromorphone Hydrochloride

Brand Name : Jurnista

Dosage Form : Hydromorphone 4Mg 14 Joined' Oral Use Rp

Dosage Strength : 14 CPR 4 mg prolonged release

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

JANSSEN CILAG SpA

IPPE

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JANSSEN CILAG SpA

IPPE

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Regulatory Info :

Registration Country : Italy

Hydromorphone Hydrochloride

Brand Name : Jurnista

Dosage Form : Hydromorphone 64Mg 14 Joined' Oral Use Rp

Dosage Strength : 14 CPR 64 mg prolonged release

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

JANSSEN CILAG SpA

IPPE

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JANSSEN CILAG SpA

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Regulatory Info :

Registration Country : Italy

Hydromorphone Hydrochloride

Brand Name : Jurnista

Dosage Form : Hydromorphone 8Mg 14 Joined' Oral Use Rp

Dosage Strength : 14 CPR 8 mg prolonged release

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

Janssen Cilag Sa

IPPE

Not Confirmed

Janssen Cilag Sa

IPPE

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Digital Content

Regulatory Info : Cancelled

Registration Country : Spain

Hydromorphone Hydrochloride

Brand Name : Jurisdictor

Dosage Form : Extended-Release Tablet

Dosage Strength : 8MG

Packaging :

Approval Date : 2006-09-05

Application Number : 68018

Regulatory Info : Cancelled

Registration Country : Spain

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Digital Content

Corporate PDF

09

Mundipharma Ab

IPPE

Not Confirmed

Mundipharma Ab

IPPE

Not Confirmed

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Regulatory Info : Deregistered

Registration Country : Sweden

Atropine Sulfate Monohydrate; Hydromorphone Hydrochloride

Brand Name : Palladon Comp

Dosage Form : Injectable Solution

Dosage Strength :

Packaging :

Approval Date : 21/03/1935

Application Number : 19350321000028

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

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10

Mundipharma Pharmaceuticals Sl

IPPE

Not Confirmed

Mundipharma Pharmaceuticals Sl

IPPE

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Regulatory Info : Cancelled

Registration Country : Spain

Hydromorphone Hydrochloride

Brand Name : Palladone Continus

Dosage Form : Extended-Release Hard Capsule

Dosage Strength : 16MG

Packaging :

Approval Date : 2001-05-10

Application Number : 63887

Regulatory Info : Cancelled

Registration Country : Spain

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Corporate PDF

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