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Hydromorphone Hydrochloride
Listed Dossiers

munit-sa-m-2025-04-14

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

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SPI Pharma has been solving formulation challenges using superior functional materials.

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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Suanfarma, at the Core of a Better Life.

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xyz-pharma-m-2025-04-14

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Hydromorphone Hydrochloride

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 11 USDMF, 7 CEP/COS, 1 JDMF, 2 KDMF, 22 NDC API, 9 Listed Suppliers, $ API Reference Price

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

FINISHED DOSAGE FORMULATIONS

219 FDF Dossiers, 76 FDA Orange Book, 36 Europe, 42 Canada, 40 Australia, 5 South Africa, 20 Listed Dossiers

219 FDF Dossiers
76 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- 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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, 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, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

85 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 35 Controlled & Modified Release, 32 Direct Compression, 28 Film Formers & Plasticizers, 28 Solubilizers, 27 Thickeners and Stabilizers, 26 Parenteral, 24 Granulation, 20 Disintegrants & Superdisintegrants, 19 Taste Masking, 19 Topical, 18 Lubricants & Glidants, 17 Co-Processed Excipients, 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

85 Fillers, Diluents & Binders
56 Coating Systems & Additives
35 Controlled & Modified Release
32 Direct Compression
28 Film Formers & Plasticizers
28 Solubilizers
27 Thickeners and Stabilizers
26 Parenteral
24 Granulation
20 Disintegrants & Superdisintegrants
19 Taste Masking
19 Topical
18 Lubricants & Glidants
17 Co-Processed Excipients
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

2 US Medicaid Prescriptions, 46 Regulatory FDF Prices

2 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 USP, 5 Others

2 EDQM
3 USP
5 Others

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

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filter Applicant Reset all filters

20 All

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

Product Main Page

01

G.L. Pharma

German Wound Congress

Not Confirmed

G.L. Pharma

German Wound Congress

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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

Packaging :

Approval Date :

Application Number :

Regulatory Info : Dossier Availability- Q2 2017

Registration Country : Austria

Product Web Link

Digital Content

01

G.L. Pharma

German Wound Congress

Not Confirmed

G.L. Pharma

German Wound Congress

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Packaging :

Regulatory Info : Dossier Availability- Q2 2017

Hydromorphone Hydrochloride

Dosage : Solution for Injection

Dosage Strength : 10MG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : Austria

Product Web Link

Digital Content

02

G.L. Pharma

German Wound Congress

Not Confirmed

G.L. Pharma

German Wound Congress

Not Confirmed

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Digital Content

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

Product Web Link

Digital Content

02

G.L. Pharma

German Wound Congress

Not Confirmed

G.L. Pharma

German Wound Congress

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Digital Content

Packaging :

Regulatory Info : Dossier Availability- Q2 2017

Hydromorphone Hydrochloride

Dosage : Solution for Injection

Dosage Strength : 20MG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : Austria

Product Web Link

Digital Content

03

G.L. Pharma

German Wound Congress

Not Confirmed

G.L. Pharma

German Wound Congress

Not Confirmed

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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

Packaging :

Approval Date :

Application Number :

Regulatory Info : Dossier Availability- Q2 2017

Registration Country : Austria

Product Web Link

Digital Content

03

G.L. Pharma

German Wound Congress

Not Confirmed

G.L. Pharma

German Wound Congress

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Digital Content

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

Product Web Link

Digital Content

04

Hana Pharm Co Ltd

German Wound Congress

Not Confirmed

Hana Pharm Co Ltd

German Wound Congress

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Digital Content

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

Portfolio PDF

Product Web Link

Digital Content

04

Hana Pharm Co Ltd

German Wound Congress

Not Confirmed

Hana Pharm Co Ltd

German Wound Congress

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Digital Content

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

Product Web Link

Digital Content

05

Hana Pharm Co Ltd

German Wound Congress

Not Confirmed

Hana Pharm Co Ltd

German Wound Congress

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Korea

Hydromorphone

Brand Name : Dilid

Dosage Form : INJECTION

Dosage Strength : 1MG

Packaging : 1mL x 10A

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Korea

Portfolio PDF

Product Web Link

Digital Content

05

Hana Pharm Co Ltd

German Wound Congress

Not Confirmed

Hana Pharm Co Ltd

German Wound Congress

Not Confirmed

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Digital Content

Packaging : 1mL x 10A

Regulatory Info : Generic

Hydromorphone

Dosage : INJECTION

Dosage Strength : 1MG

Brand Name : Dilid

Approval Date :

Application Number :

Registration Country : South Korea

Portfolio PDF

Product Web Link

Digital Content

06

Hana Pharm Co Ltd

German Wound Congress

Not Confirmed

Hana Pharm Co Ltd

German Wound Congress

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Korea

Hydromorphone

Brand Name : Dilid

Dosage Form : INJECTION

Dosage Strength : 2MG

Packaging : 2mL x 10A

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Korea

Portfolio PDF

Product Web Link

Digital Content

06

Hana Pharm Co Ltd

German Wound Congress

Not Confirmed

Hana Pharm Co Ltd

German Wound Congress

Not Confirmed

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Digital Content

Packaging : 2mL x 10A

Regulatory Info : Generic

Hydromorphone

Dosage : INJECTION

Dosage Strength : 2MG

Brand Name : Dilid

Approval Date :

Application Number :

Registration Country : South Korea

Portfolio PDF

Product Web Link

Digital Content

07

Mallinckrodt Plc

German Wound Congress

Not Confirmed

Mallinckrodt Plc

German Wound Congress

Not Confirmed

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Regulatory Info :

Registration Country : U.S.A

Hydromorphone Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 2MG

Packaging : Size: 100s

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Mallinckrodt Plc

German Wound Congress

Not Confirmed

Mallinckrodt Plc

German Wound Congress

Not Confirmed

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Digital Content

Packaging : Size: 100s

Regulatory Info :

Hydromorphone Hydrochloride

Dosage : Tablet

Dosage Strength : 2MG

Brand Name :

Approval Date :

Application Number :

Registration Country : U.S.A

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Mallinckrodt Plc

German Wound Congress

Not Confirmed

Mallinckrodt Plc

German Wound Congress

Not Confirmed

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Regulatory Info :

Registration Country : U.S.A

Hydromorphone Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 4MG

Packaging : Size: 100s

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Mallinckrodt Plc

German Wound Congress

Not Confirmed

Mallinckrodt Plc

German Wound Congress

Not Confirmed

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Packaging : Size: 100s

Regulatory Info :

Hydromorphone Hydrochloride

Dosage : Tablet

Dosage Strength : 4MG

Brand Name :

Approval Date :

Application Number :

Registration Country : U.S.A

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Mallinckrodt Plc

German Wound Congress

Not Confirmed

Mallinckrodt Plc

German Wound Congress

Not Confirmed

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Regulatory Info :

Registration Country : U.S.A

Hydromorphone Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 8MG

Packaging : Size: 100s

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Mallinckrodt Plc

German Wound Congress

Not Confirmed

Mallinckrodt Plc

German Wound Congress

Not Confirmed

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Digital Content

Packaging : Size: 100s

Regulatory Info :

Hydromorphone Hydrochloride

Dosage : Tablet

Dosage Strength : 8MG

Brand Name :

Approval Date :

Application Number :

Registration Country : U.S.A

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Mallinckrodt Plc

German Wound Congress

Not Confirmed

Mallinckrodt Plc

German Wound Congress

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Regulatory Info :

Registration Country : U.S.A

Hydromorphone Hydrochloride

Brand Name :

Dosage Form : Extended Release Table...

Dosage Strength : 8MG

Packaging : Size: 100s

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Mallinckrodt Plc

German Wound Congress

Not Confirmed

Mallinckrodt Plc

German Wound Congress

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Packaging : Size: 100s

Regulatory Info :

Hydromorphone Hydrochloride

Dosage : Extended Release Table...

Dosage Strength : 8MG

Brand Name :

Approval Date :

Application Number :

Registration Country : U.S.A

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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