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Hydromorphone Hydrochloride

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ACTIVE PHARMA INGREDIENTS

20 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

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- 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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 Solubilizers, 28 Film Formers & Plasticizers, 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 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 58 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 46 Regulatory FDF Prices

MARKET PLACE

1 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 1 US Exclusivities, 12 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 3 USP, 5 Others

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Veranova	U.S.A	VERANOVA LP	19846	HYDROMORPHONE HCI, USP	2006-10-06	Active	II	Complete	2014-06-06	2014-05-28
28/03/2025	Noramco	U.S.A	NORAMCO LLC	19561	HYDROMORPHONE HYDROCHLORIDE DRUG SUBSTANCE	2006-06-29	Active	II	Complete	2013-02-06	2012-11-23

Hydromorphone Hydrochloride

Hydromorphone Hydrochloride

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

20 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

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**

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

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