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Approved Drug Products containing Hydromorphone Hydrochloride listed with Health Canada. Original Data : Health Canada Website

Client Email

Product

Hydromorphone Hydrochloride
CAS 57-27-2
Canada

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 Hydrochloride

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- 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for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

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42 All

01 4APOTEX INC

02 2FRESENIUS KABI CANADA LTD

03 1JAMP PHARMA CORPORATION

04 1PFIZER CANADA ULC

05 5PHARMASCIENCE INC

06 12PURDUE PHARMA

07 6Pharmascience Inc.

08 5SANDOZ CANADA INCORPORATED

09 4STERIMAX INC

10 2STERINOVA INC.

filter Active Ingredients Reset all filters

42 All

01 36HYDROMORPHONE HYDROCHLORIDE

02 6Hydromorphone

filter Dosage Form Reset all filters

42 All

01 8CAPSULE (SUSTAINED-RELEASE)

02 15SOLUTION

03 1SUPPOSITORY

04 2SYRUP

05 16TABLET

filter Brand Name Reset all filters

42 All

01 4APO-HYDROMORPHONE

02 4DILAUDID

03 2HYDROMORPH CONTIN

04 1HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 12MG

05 1HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 18MG

06 1HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 24MG

07 1HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 30MG

08 1HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 3MG

09 1HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 6MG

10 1HYDROMORPHONE HP 10

11 1HYDROMORPHONE HP 20

12 1HYDROMORPHONE HP 50

13 1HYDROMORPHONE HYDROCHLORIDE INJECTION

14 1HYDROMORPHONE HYDROCHLORIDE INJECTION HP 10

15 1HYDROMORPHONE HYDROCHLORIDE INJECTION HP 50

16 1HYDROMORPHONE HYDROCHLORIDE INJECTION HP FORTE

17 6HYDROMORPHONE HYDROCHLORIDE INJECTION USP

18 2HYDROMORPHONE HYDROCHLORIDE INJECTION, USP

19 2PMS HYDROMORPHONE SIROP 1MG/ML

20 1PMS HYDROMORPHONE SUPPOSITOIRE 3MG

21 2PMS-HYDROMORPHONE TAB 1MG

22 2PMS-HYDROMORPHONE TAB 2MG

23 2PMS-HYDROMORPHONE TAB 4MG

24 2PMS-HYDROMORPHONE TAB 8MG

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

List of Suppliers

Product Main Page

01

Pharmascience Inc.

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Pharmascience Inc.

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Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

Hydromorphone

Brand Name : PMS HYDROMORPHONE SUPPOSITOIRE 3MG

Dosage Form : SUPPOSITORY

Dosage Strength : 3MG

Packaging : 10

Approval Date :

Application Number :

Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

Portfolio PDF

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02

Pharmascience Inc.

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Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

Hydromorphone

Brand Name : PMS-HYDROMORPHONE TAB 2MG

Dosage Form : TABLET

Dosage Strength : 2MG

Packaging : 100, 4 X 25 (CONTROL PACK)

Approval Date :

Application Number :

Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

Portfolio PDF

Product Web Link

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03

Pharmascience Inc.

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Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

Hydromorphone

Brand Name : PMS-HYDROMORPHONE TAB 4MG

Dosage Form : TABLET

Dosage Strength : 4MG

Packaging : 100, 4 X 25 (CONTROL PACK)

Approval Date :

Application Number :

Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

04

Pharmascience Inc.

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Digital Content

Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

Hydromorphone

Brand Name : PMS-HYDROMORPHONE TAB 1MG

Dosage Form : TABLET

Dosage Strength : 1MG

Packaging : 100, 4 X 25 (CONTROL PACK)

Approval Date :

Application Number :

Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

05

Pharmascience Inc.

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Pharmascience Inc.

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Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

Hydromorphone

Brand Name : PMS-HYDROMORPHONE TAB 8MG

Dosage Form : TABLET

Dosage Strength : 8MG

Packaging : 100, 4 X 25 (CONTROL PACK)

Approval Date :

Application Number :

Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

06

Pharmascience Inc.

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Pharmascience Inc.

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Digital Content

Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

Hydromorphone

Brand Name : PMS HYDROMORPHONE SIROP 1MG/ML

Dosage Form : SYRUP

Dosage Strength : 1MG

Packaging : 500ML

Approval Date :

Application Number :

Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

07

PURDUE PHARMA

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PURDUE PHARMA

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Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

HYDROMORPHONE HYDROCHLORIDE

Brand Name : HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 30MG

Dosage Form : CAPSULE (SUSTAINED-RELEASE)

Dosage Strength : 30MG

Packaging : 50

Approval Date :

Application Number : 2125390

Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

PURDUE PHARMA

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PURDUE PHARMA

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Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

HYDROMORPHONE HYDROCHLORIDE

Brand Name : HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 12MG

Dosage Form : CAPSULE (SUSTAINED-RELEASE)

Dosage Strength : 12MG

Packaging : 50

Approval Date :

Application Number : 2125366

Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

PURDUE PHARMA

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PURDUE PHARMA

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Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

HYDROMORPHONE HYDROCHLORIDE

Brand Name : HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 24MG

Dosage Form : CAPSULE (SUSTAINED-RELEASE)

Dosage Strength : 24MG

Packaging : 50

Approval Date :

Application Number : 2125382

Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

Portfolio PDF

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Digital Content

Corporate PDF

10

SANDOZ CANADA INCORPORATED

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SANDOZ CANADA INCORPORATED

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Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

HYDROMORPHONE HYDROCHLORIDE

Brand Name : HYDROMORPHONE HYDROCHLORIDE INJECTION USP

Dosage Form : SOLUTION

Dosage Strength : 2MG/ML

Packaging : 10X1ML

Approval Date :

Application Number : 2145901

Regulatory Info : Narcotic (CDSA I)

Registration Country : Canada

Product Web Link

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