Hydromorphone Hydrochloride | Health Canada | Drug Product Database | DPD | PharmaCompass.com

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Hydromorphone Hydrochloride
Canada

With Fermion, start the journey of your innovative API.

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Suanfarma CDMO offers integrated end-to-end solutions for development & commercialization of intermediates & APIs for small molecules.

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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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Hydromorphone Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

33 API Suppliers, 11 USDMF, 7 CEP/COS, 1 JDMF, 2 KDMF, 19 NDC API, 9 Listed Suppliers, $ API Reference Price

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

FINISHED DOSAGE FORMULATIONS

216 FDF Dossiers, 76 FDA Orange Book, 36 Europe, 42 Canada, 37 Australia, 5 South Africa, 20 Listed Dossiers

216 FDF Dossiers
76 FDA Orange Book
36 Europe
42 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- 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 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, 1 Ashland, 26 BASF, 1 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 2 Ingredion Pharma Solutions, 39 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 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

86 Fillers, Diluents & Binders, 54 Coating Systems & Additives, 35 Controlled & Modified Release, 31 Direct Compression, 28 Solubilizers, 27 Film Formers & Plasticizers, 26 Parenteral, 26 Thickeners and Stabilizers, 24 Granulation, 22 Co-Processed Excipients, 20 Disintegrants & Superdisintegrants, 20 Topical, 19 Taste Masking, 18 Lubricants & Glidants, 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

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

17 US Medicaid Prescriptions, 46 Regulatory FDF Prices

17 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 Others

2 EDQM
3 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

List of Suppliers

Product Main Page

01

Pharmascience Inc.

Pharmex

Not Confirmed

Pharmascience Inc.

Pharmex

Not Confirmed

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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

Product Web Link

Digital Content

Corporate PDF

02

Pharmascience Inc.

Pharmex

Not Confirmed

Pharmascience Inc.

Pharmex

Not Confirmed

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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

Digital Content

Corporate PDF

03

Pharmascience Inc.

Pharmex

Not Confirmed

Pharmascience Inc.

Pharmex

Not Confirmed

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Digital Content

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

Corporate PDF

04

Pharmascience Inc.

Pharmex

Not Confirmed

Pharmascience Inc.

Pharmex

Not Confirmed

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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

Corporate PDF

05

Pharmascience Inc.

Pharmex

Not Confirmed

Pharmascience Inc.

Pharmex

Not Confirmed

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Digital Content

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

Corporate PDF

06

Pharmascience Inc.

Pharmex

Not Confirmed

Pharmascience Inc.

Pharmex

Not Confirmed

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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

Corporate PDF

07

PURDUE PHARMA

Pharmex

Not Confirmed

PURDUE PHARMA

Pharmex

Not Confirmed

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Regulatory Info :

Registration Country : Canada

HYDROMORPHONE HYDROCHLORIDE

Brand Name : DILAUDID

Dosage Form : TABLET

Dosage Strength : 2MG

Packaging : 25/100

Approval Date :

Application Number : 125083

Regulatory Info :

Registration Country : Canada

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Product Web Link

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Corporate PDF

08

PURDUE PHARMA

Pharmex

Not Confirmed

PURDUE PHARMA

Pharmex

Not Confirmed

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Regulatory Info :

Registration Country : Canada

HYDROMORPHONE HYDROCHLORIDE

Brand Name : DILAUDID

Dosage Form : TABLET

Dosage Strength : 4MG

Packaging : 25/100

Approval Date :

Application Number : 125121

Regulatory Info :

Registration Country : Canada

Portfolio PDF

Product Web Link

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Corporate PDF

09

PURDUE PHARMA

Pharmex

Not Confirmed

PURDUE PHARMA

Pharmex

Not Confirmed

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Regulatory Info :

Registration Country : Canada

HYDROMORPHONE HYDROCHLORIDE

Brand Name : DILAUDID

Dosage Form : TABLET

Dosage Strength : 1MG

Packaging : 25/100

Approval Date :

Application Number : 705438

Regulatory Info :

Registration Country : Canada

Portfolio PDF

Product Web Link

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Corporate PDF

10

PURDUE PHARMA

Pharmex

Not Confirmed

PURDUE PHARMA

Pharmex

Not Confirmed

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Regulatory Info :

Registration Country : Canada

HYDROMORPHONE HYDROCHLORIDE

Brand Name : DILAUDID

Dosage Form : TABLET

Dosage Strength : 8MG

Packaging : 25/100

Approval Date :

Application Number : 786543

Regulatory Info :

Registration Country : Canada

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Digital Content

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