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Hydromorphone Hydrochloride
Listed Dossiers

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

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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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USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.

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

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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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Guizhou Utide Biotechnology Co., Ltd. - Specialized GMP manufacturing for next-generation GLP-1 peptide APIs.

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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

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- 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for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 Gloria Interchem, 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, 1 Neelkanth MineChem, 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, 30 Thickeners and Stabilizers, 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, 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
30 Thickeners and Stabilizers
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
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

14 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 5 Others

2 EDQM
5 Others

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

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01 2Ascent Pharmaceuticals

02 4Farbe Firma

03 3G.L. Pharma

04 3Hana Pharm Co Ltd

05 8Mallinckrodt Plc

filter Active Ingredients Reset all filters

20 All

01 2HYDROMORPHONE HCL

02 3Hydromorphone

03 15Hydromorphone Hydrochloride

filter Dosage Reset all filters

20 All

01 4Extended Release Tablet

02 2INJECTION

03 4Injection

04 1Powder

05 3Solution for Injection

06 1TABLET

07 5Tablet

filter Dosage Strength Reset all filters

20 All

01 510MG/ML

02 112MG

03 116MG

04 11MG

05 120MG/ML

06 42MG

07 132MG

08 24MG

09 150MG/ML

10 28MG

11 1Blank

filter Country Reset all filters

20 All

01 3Austria

02 4India

03 3South Korea

04 10U.S.A

List of Suppliers

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01

Ascent Pharmaceuticals

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Regulatory Info :

Registration Country : U.S.A

HYDROMORPHONE HCL

Brand Name : Dilaudid

Dosage Form : Tablet

Dosage Strength : 2MG

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Registration Country : U.S.A

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HYDROMORPHONE HCL

Dosage : Tablet

Dosage Strength : 2MG

Brand Name : Dilaudid

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Registration Country : U.S.A

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HYDROMORPHONE HCL

Brand Name : Dilaudid

Dosage Form : Tablet

Dosage Strength : 4MG

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Registration Country : U.S.A

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HYDROMORPHONE HCL

Dosage : Tablet

Dosage Strength : 4MG

Brand Name : Dilaudid

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Registration Country : U.S.A

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Farbe Firma

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Registration Country : India

Hydromorphone Hydrochloride

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Dosage Form : Injection

Dosage Strength : 10MG/ML

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Hydromorphone Hydrochloride

Dosage : Injection

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Registration Country : India

Hydromorphone Hydrochloride

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Dosage Form : Injection

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Hydromorphone Hydrochloride

Dosage : Injection

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Registration Country : India

Hydromorphone Hydrochloride

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Dosage Form : Injection

Dosage Strength : 10MG/ML

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Farbe Firma

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Hydromorphone Hydrochloride

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Farbe Firma

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Registration Country : India

Hydromorphone Hydrochloride

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Dosage Form : Injection

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Farbe Firma

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Hydromorphone Hydrochloride

Dosage : Injection

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Regulatory Info : Dossier Availability- Q2 2017

Registration Country : Austria

Hydromorphone Hydrochloride

Brand Name :

Dosage Form : Solution for Injection

Dosage Strength : 10MG/ML

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Regulatory Info : Dossier Availability- Q2 2017

Registration Country : Austria

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Regulatory Info : Dossier Availability- Q2 2017

Hydromorphone Hydrochloride

Dosage : Solution for Injection

Dosage Strength : 10MG/ML

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Approval Date :

Application Number :

Registration Country : Austria

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08

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Regulatory Info : Dossier Availability- Q2 2017

Registration Country : Austria

Hydromorphone Hydrochloride

Brand Name :

Dosage Form : Solution for Injection

Dosage Strength : 20MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : Dossier Availability- Q2 2017

Registration Country : Austria

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08

G.L. Pharma

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Regulatory Info : Dossier Availability- Q2 2017

Hydromorphone Hydrochloride

Dosage : Solution for Injection

Dosage Strength : 20MG/ML

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Approval Date :

Application Number :

Registration Country : Austria

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G.L. Pharma

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Regulatory Info : Dossier Availability- Q2 2017

Registration Country : Austria

Hydromorphone Hydrochloride

Brand Name :

Dosage Form : Solution for Injection

Dosage Strength : 50MG/ML

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Approval Date :

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Regulatory Info : Dossier Availability- Q2 2017

Registration Country : Austria

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G.L. Pharma

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Packaging :

Regulatory Info : Dossier Availability- Q2 2017

Hydromorphone Hydrochloride

Dosage : Solution for Injection

Dosage Strength : 50MG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : Austria

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10

Hana Pharm Co Ltd

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Regulatory Info : Generic

Registration Country : South Korea

Hydromorphone

Brand Name : Dilid

Dosage Form : TABLET

Dosage Strength : 2MG

Packaging : 100 T

Approval Date :

Application Number : 78439

Regulatory Info : Generic

Registration Country : South Korea

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Hana Pharm Co Ltd

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Hana Pharm Co Ltd

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Packaging : 100 T

Regulatory Info : Generic

Hydromorphone

Dosage : TABLET

Dosage Strength : 2MG

Brand Name : Dilid

Approval Date :

Application Number : 78439

Registration Country : South Korea

Portfolio PDF

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