Hydromorphone Hydrochloride | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Hydromorphone Hydrochloride
Europe

With Fermion, start the journey of your innovative API.

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Suanfarma CDMO offers integrated end-to-end solutions for development & commercialization of intermediates & APIs for small molecules.

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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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Hydromorphone Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

33 API Suppliers, 11 USDMF, 7 CEP/COS, 1 JDMF, 2 KDMF, 19 NDC API, 9 Listed Suppliers, $ API Reference Price

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

FINISHED DOSAGE FORMULATIONS

216 FDF Dossiers, 76 FDA Orange Book, 36 Europe, 42 Canada, 37 Australia, 5 South Africa, 20 Listed Dossiers

216 FDF Dossiers
76 FDA Orange Book
36 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- 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 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, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 2 Ingredion Pharma Solutions, 39 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

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

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

17 US Medicaid Prescriptions, 46 Regulatory FDF Prices

17 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

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36 All

01 5JANSSEN CILAG SpA

02 10Mundipharma AB

03 10Mundipharma AS

04 10Mundipharma Medical Company Hamilton,Bermuda,Basel Branch

05 1Streuli Pharma AG

filter Active Ingredients Reset all filters

36 All

01 15Hydromorphone Hydrochloride

02 11Hydromorphoni hydrochloridum

03 10hydromorphone

filter Dosage Form Reset all filters

36 All

01 2Capsule, hard

02 2HARD CAPSULES

03 1Hydromorphone 16Mg 14 Joined' Oral Use Rp

04 1Hydromorphone 32Mg 14 Joined' Oral Use Rp

05 1Hydromorphone 4Mg 14 Joined' Oral Use Rp

06 1Hydromorphone 64Mg 14 Joined' Oral Use Rp

07 1Hydromorphone 8Mg 14 Joined' Oral Use Rp

08 4INJECTION / INFUSION

09 4Injection/infusion fluid, resolution

10 2Kaps

11 4PROLONGED-RELEASE CAPSULE, HARD

12 4Pit capsule, hard

13 8Ret Kaps

14 1Tropfen

filter Country Reset all filters

36 All

01 5Italy

02 10Norway

03 10Sweden

04 11Switzerland

filter Brand Name Reset all filters

36 All

01 1Hydromorphoni HCl Streuli

02 5Jurnista

03 30Palladon

List of Suppliers

Product Main Page

01

Mundipharma AB

Pharmex

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Mundipharma AB

Pharmex

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Regulatory Info :

Registration Country : Sweden

hydromorphone

Brand Name : Palladon

Dosage Form : PROLONGED-RELEASE CAPSULE, HARD

Dosage Strength : 8 MG

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Approval Date :

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Regulatory Info :

Registration Country : Sweden

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02

Mundipharma AB

Pharmex

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Mundipharma AB

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Regulatory Info :

Registration Country : Sweden

hydromorphone

Brand Name : Palladon

Dosage Form : PROLONGED-RELEASE CAPSULE, HARD

Dosage Strength : 24 MG

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Regulatory Info :

Registration Country : Sweden

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03

Mundipharma AB

Pharmex

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Mundipharma AB

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Regulatory Info :

Registration Country : Sweden

hydromorphone

Brand Name : Palladon

Dosage Form : PROLONGED-RELEASE CAPSULE, HARD

Dosage Strength : 4 MG

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Registration Country : Sweden

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Mundipharma AB

Pharmex

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Registration Country : Sweden

hydromorphone

Brand Name : Palladon

Dosage Form : PROLONGED-RELEASE CAPSULE, HARD

Dosage Strength : 16 MG

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Registration Country : Sweden

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Mundipharma AB

Pharmex

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Regulatory Info :

Registration Country : Sweden

hydromorphone

Brand Name : Palladon

Dosage Form : HARD CAPSULES

Dosage Strength : 1.3 MG

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Regulatory Info :

Registration Country : Sweden

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06

Mundipharma AB

Pharmex

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Regulatory Info :

Registration Country : Sweden

hydromorphone

Brand Name : Palladon

Dosage Form : HARD CAPSULES

Dosage Strength : 2.6 MG

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Registration Country : Sweden

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07

Mundipharma AB

Pharmex

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Mundipharma AB

Pharmex

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Regulatory Info :

Registration Country : Sweden

hydromorphone

Brand Name : Palladon

Dosage Form : INJECTION / INFUSION

Dosage Strength : 50 MG / ML

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Registration Country : Sweden

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08

Mundipharma AB

Pharmex

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Mundipharma AB

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Regulatory Info :

Registration Country : Sweden

hydromorphone

Brand Name : Palladon

Dosage Form : INJECTION / INFUSION

Dosage Strength : 20 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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09

Mundipharma AB

Pharmex

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Mundipharma AB

Pharmex

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Regulatory Info :

Registration Country : Sweden

hydromorphone

Brand Name : Palladon

Dosage Form : INJECTION / INFUSION

Dosage Strength : 2 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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10

Mundipharma AB

Pharmex

Not Confirmed

Mundipharma AB

Pharmex

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Regulatory Info :

Registration Country : Sweden

hydromorphone

Brand Name : Palladon

Dosage Form : INJECTION / INFUSION

Dosage Strength : 10 MG / ML

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Registration Country : Sweden

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