Hydromorphone Hydrochloride | Australian Register of Therapeutic Goods | Australia | PharmaCompass.com

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Hydromorphone Hydrochloride
Australia

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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xyz-pharma-m-2024-10-07

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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, 23 NDC API, 9 Listed Suppliers, $ API Reference Price

20 API Suppliers
11 USDMF
7 CEP/COS
1 JDMF
2 KDMF
23 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- 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

1 Evonik, 2 Rochem International Inc, 14 SPI Pharma, 2 Seqens, 4 DKSH, 4 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 11 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

89 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 40 Direct Compression, 36 Controlled & Modified Release, 29 Film Formers & Plasticizers, 27 Solubilizers, 27 Parenteral, 26 Thickeners and Stabilizers, 24 Granulation, 21 Co-Processed Excipients, 19 Lubricants & Glidants, 18 Topical, 18 Taste Masking, 17 Disintegrants & Superdisintegrants, 13 Chewable & Orodispersible Aids, 8 Emulsifying Agents, 8 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

89 Fillers, Diluents & Binders
56 Coating Systems & Additives
40 Direct Compression
36 Controlled & Modified Release
29 Film Formers & Plasticizers
27 Solubilizers
27 Parenteral
26 Thickeners and Stabilizers
24 Granulation
21 Co-Processed Excipients
19 Lubricants & Glidants
18 Topical
18 Taste Masking
17 Disintegrants & Superdisintegrants
13 Chewable & Orodispersible Aids
8 Emulsifying Agents
8 API Stability Enhancers
5 Empty Capsules
5 Coloring Agents
4 Rheology Modifiers
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 58 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
58 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, 3 US Exclusivities, 12 Health Canada Patents

14 US Patents
3 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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40 All

01 4HAMELN PHARMA PTY. LTD.

02 4Juno Pharmaceuticals Pty Ltd

03 3Link Medical Products Pty Ltd

04 10Medsurge Healthcare Pty Ltd

05 19Mundipharma Pty Limited

filter Active Ingredients Reset all filters

40 All

01 40hydromorphone

filter Dosage Form Reset all filters

40 All

01 16injection

02 15tablet

03 9Blank

filter Brand Name Reset all filters

40 All

01 17Dilaudid

02 2Dilaudid-HP

03 2HYDROMORPHONE JUNO

04 2HYDROMORPHONE JUNO-HP

05 3Hikma

06 3Hydromorphone hydrochloride oral solution, US

07 2Hydromorphone-hameln

08 2Hydromorphone-hameln-HP

09 2MEDSURGE HYDROMORPHONE 2 mg/1 mL

10 2MEDSURGE HYDROMORPHONE HP 10 mg/1 mL

11 3pms-HYDROmorphone

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01

Juno Pharmaceuticals Pty Ltd

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Juno Pharmaceuticals Pty Ltd

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Regulatory Info :

Registration Country : Australia

hydromorphone

Brand Name : HYDROMORPHONE JUNO

Dosage Form : injection

Dosage Strength : 2 mg/mL

Packaging : 5

Approval Date :

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Regulatory Info :

Registration Country : Australia

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02

Medsurge Healthcare Pty Ltd

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Medsurge Healthcare Pty Ltd

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Regulatory Info :

Registration Country : Australia

hydromorphone

Brand Name : MEDSURGE HYDROMORPHONE 2 mg/1 mL

Dosage Form : injection

Dosage Strength : 2 mg/mL

Packaging : 5

Approval Date :

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Registration Country : Australia

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03

Mundipharma Pty Limited

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Mundipharma Pty Limited

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Regulatory Info :

Registration Country : Australia

hydromorphone

Brand Name : Dilaudid

Dosage Form : tablet

Dosage Strength : 8 mg

Packaging : 20

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Registration Country : Australia

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04

Mundipharma Pty Limited

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Mundipharma Pty Limited

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Regulatory Info :

Registration Country : Australia

hydromorphone

Brand Name : Dilaudid

Dosage Form : tablet

Dosage Strength : 8 mg

Packaging : 20

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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05

Mundipharma Pty Limited

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Mundipharma Pty Limited

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Regulatory Info :

Registration Country : Australia

hydromorphone

Brand Name : Dilaudid

Dosage Form : tablet

Dosage Strength : 4 mg

Packaging : 20

Approval Date :

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Regulatory Info :

Registration Country : Australia

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06

Mundipharma Pty Limited

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Mundipharma Pty Limited

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Regulatory Info :

Registration Country : Australia

hydromorphone

Brand Name : Dilaudid

Dosage Form : tablet

Dosage Strength : 2 mg

Packaging : 20

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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07

Mundipharma Pty Limited

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Mundipharma Pty Limited

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Regulatory Info :

Registration Country : Australia

hydromorphone

Brand Name : Dilaudid

Dosage Form : tablet

Dosage Strength : 4 mg

Packaging : 20

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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08

Mundipharma Pty Limited

Antibody Engineering

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Mundipharma Pty Limited

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Digital Content

Regulatory Info :

Registration Country : Australia

hydromorphone

Brand Name : Dilaudid

Dosage Form : tablet

Dosage Strength : 2 mg

Packaging : 20

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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09

Mundipharma Pty Limited

Antibody Engineering

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Mundipharma Pty Limited

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Digital Content

Regulatory Info :

Registration Country : Australia

hydromorphone

Brand Name : Dilaudid

Dosage Form : tablet

Dosage Strength : 4 mg

Packaging : 20

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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10

HAMELN PHARMA PTY. LTD.

Country

Antibody Engineering

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HAMELN PHARMA PTY. LTD.

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Registration Country : Australia

hydromorphone

Brand Name : Hydromorphone-hameln

Dosage Form : injection

Dosage Strength : 2 mg/mL

Packaging : 5

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Registration Country : Australia

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