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

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Hydromorphone Hydrochloride
South Africa

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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SPI Pharma has been solving formulation challenges using superior functional materials.

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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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FAMAR CDMO- From early development to commercial manufacturing.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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- 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for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

2 EUROAPI, 1 Evonik, 2 Rochem International Inc, 15 SPI Pharma, 2 Seqens, 4 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

86 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 35 Controlled & Modified Release, 32 Direct Compression, 29 Film Formers & Plasticizers, 28 Parenteral, 28 Solubilizers, 25 Thickeners and Stabilizers, 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, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Rheology Modifiers, 1 Soft Gelatin

86 Fillers, Diluents & Binders
56 Coating Systems & Additives
35 Controlled & Modified Release
32 Direct Compression
29 Film Formers & Plasticizers
28 Parenteral
28 Solubilizers
25 Thickeners and Stabilizers
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
5 Empty Capsules
5 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
4 Rheology Modifiers
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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01 1Jurnista 16 Mg

02 2Jurnista 4 Mg

03 2Jurnista 8 Mg

List of Suppliers

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01

Janssen Pharmaceutica (Pty) Ltd

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Janssen Pharmaceutica (Pty) Ltd

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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

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Digital Content

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02

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

Not Confirmed

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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

03

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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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

04

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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

05

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

Not Confirmed

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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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