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Approved Marketing Authorisations (MA) containing HYDROMORPHONE HCL in Europe. Original Data : EMA Website

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HYDROMORPHONE HCL
Europe

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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HYDROMORPHONE HCL

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

21 API Suppliers, 12 USDMF, 7 CEP/COS, 1 JDMF, 2 KDMF, 23 NDC API, 10 Listed Suppliers, $ API Reference Price

21 API Suppliers
12 USDMF
7 CEP/COS
1 JDMF
2 KDMF
23 NDC API
10 Listed Suppliers
$ API Reference Price

PRICE INFORMATION

API Reference Price

API Reference Price

FINISHED DOSAGE FORMULATIONS

218 FDF Dossiers, 75 FDA Orange Book, 36 Europe, 42 Canada, 40 Australia, 5 South Africa, 20 Listed Dossiers

218 FDF Dossiers
75 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- 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for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

1 Evonik, 2 Rochem International Inc, 14 SPI Pharma, 2 Seqens, 4 DKSH, 1 Jai Radhe Sales, 6 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 26 BASF, 1 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 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, 11 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

90 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 41 Direct Compression, 36 Controlled & Modified Release, 29 Film Formers & Plasticizers, 28 Solubilizers, 28 Parenteral, 26 Thickeners and Stabilizers, 24 Granulation, 20 Co-Processed Excipients, 19 Lubricants & Glidants, 18 Disintegrants & Superdisintegrants, 18 Taste Masking, 18 Topical, 13 Chewable & Orodispersible Aids, 8 API Stability Enhancers, 8 Emulsifying Agents, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Rheology Modifiers, 1 Soft Gelatin

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

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 57 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
57 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 46 Finished Drug Prices

2 US Medicaid Prescriptions
46 Finished Drug Prices

MARKET PLACE

1 APIs, 2 FDF Dossiers

1 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 2 US Exclusivities, 12 Health Canada Patents

14 US Patents
2 US Exclusivities
12 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 3 USP, 5 Others

2 EDQM
3 USP
5 Others

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

Filters

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filter Applicant Reset all filters

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

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

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Product Main Page

01

Mundipharma AB

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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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Registration Country : Sweden

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Mundipharma AB

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Registration Country : Sweden

hydromorphone

Brand Name : Palladon

Dosage Form : PROLONGED-RELEASE CAPSULE, HARD

Dosage Strength : 24 MG

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Registration Country : Sweden

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Mundipharma AB

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Registration Country : Sweden

hydromorphone

Brand Name : Palladon

Dosage Form : PROLONGED-RELEASE CAPSULE, HARD

Dosage Strength : 4 MG

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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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Regulatory Info :

Registration Country : Sweden

hydromorphone

Brand Name : Palladon

Dosage Form : HARD CAPSULES

Dosage Strength : 1.3 MG

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Registration Country : Sweden

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06

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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

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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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08

Mundipharma AB

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Registration Country : Sweden

hydromorphone

Brand Name : Palladon

Dosage Form : INJECTION / INFUSION

Dosage Strength : 20 MG / ML

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Registration Country : Sweden

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09

Mundipharma AB

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Regulatory Info :

Registration Country : Sweden

hydromorphone

Brand Name : Palladon

Dosage Form : INJECTION / INFUSION

Dosage Strength : 2 MG / ML

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Registration Country : Sweden

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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 : 10 MG / ML

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Registration Country : Sweden

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