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

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Hydromorphone Hydrochloride
South Africa

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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CHEMISTRY
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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- 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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01 1Jurnista 16 Mg

02 2Jurnista 4 Mg

03 2Jurnista 8 Mg

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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 : 28X1mg

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

Antibody Engineering

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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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03

Janssen Pharmaceutica (Pty) Ltd

Antibody Engineering

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Janssen Pharmaceutica (Pty) Ltd

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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

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04

Janssen Pharmaceutica (Pty) Ltd

Antibody Engineering

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Janssen Pharmaceutica (Pty) Ltd

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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

Antibody Engineering

Not Confirmed

Janssen Pharmaceutica (Pty) Ltd

Antibody Engineering

Not Confirmed

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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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