Hydromorphone Hydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Hydromorphone Hydrochloride
South Africa

TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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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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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

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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- 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 2 CD Formulation, 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, 25 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

72 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 37 Direct Compression, 29 Granulation, 29 Controlled & Modified Release, 28 Solubilizers, 27 Film Formers & Plasticizers, 27 Thickeners and Stabilizers, 26 Parenteral, 20 Disintegrants & Superdisintegrants, 20 Taste Masking, 20 Topical, 18 Lubricants & Glidants, 16 Chewable & Orodispersible Aids, 15 Co-Processed Excipients, 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

72 Fillers, Diluents & Binders
51 Coating Systems & Additives
37 Direct Compression
29 Granulation
29 Controlled & Modified Release
28 Solubilizers
27 Film Formers & Plasticizers
27 Thickeners and Stabilizers
26 Parenteral
20 Disintegrants & Superdisintegrants
20 Taste Masking
20 Topical
18 Lubricants & Glidants
16 Chewable & Orodispersible Aids
15 Co-Processed Excipients
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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01 1Jurnista 16 Mg

02 2Jurnista 4 Mg

03 2Jurnista 8 Mg

List of Suppliers

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01

Janssen Pharmaceutica (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

Janssen Pharmaceutica (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Hydromorphone Hci

Brand Name : Jurnista 4 Mg

Dosage Form : TAB

Dosage Strength : 4mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Janssen Pharmaceutica (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

Janssen Pharmaceutica (Pty) Ltd

BIO Asia-Taiwan

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

Regulatory Info : Originator

Registration Country : South Africa

Hydromorphone Hci

Brand Name : Jurnista 4 Mg

Dosage Form : TAB

Dosage Strength : 4mg

Packaging : 14X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Janssen Pharmaceutica (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

Janssen Pharmaceutica (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Hydromorphone Hci

Brand Name : Jurnista 8 Mg

Dosage Form : TAB

Dosage Strength : 8mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Janssen Pharmaceutica (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

Janssen Pharmaceutica (Pty) Ltd

BIO Asia-Taiwan

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

Regulatory Info : Originator

Registration Country : South Africa

Hydromorphone Hci

Brand Name : Jurnista 8 Mg

Dosage Form : TAB

Dosage Strength : 8mg

Packaging : 14X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Janssen Pharmaceutica (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

Janssen Pharmaceutica (Pty) Ltd

BIO Asia-Taiwan

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

Regulatory Info : Originator

Registration Country : South Africa

Hydromorphone Hci

Brand Name : Jurnista 16 Mg

Dosage Form : TAB

Dosage Strength : 16mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Digital Content

Corporate PDF

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