Oxycodone HCl | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Oxycodone HCl
South Africa

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Oxycodone HCl

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 13 USDMF, 11 CEP/COS, 1 JDMF, 1 EU WC, 7 KDMF, 18 NDC API, 15 Listed Suppliers, $ API Reference Price

29 API Suppliers
13 USDMF
11 CEP/COS
1 JDMF
1 EU WC
7 KDMF
18 NDC API
15 Listed Suppliers
$ API Reference Price

INTERMEDIATES

4 Intermediates Suppliers

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

799 FDF Dossiers, 290 FDA Orange Book, 345 Europe, 49 Canada, 52 Australia, 17 South Africa, 46 Listed Dossiers

799 FDF Dossiers
290 FDA Orange Book
345 Europe
49 Canada
52 Australia
17 South Africa
46 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 5MG, SOLUTION;ORAL - 100MG/5ML, SOLUTION;ORAL - 5MG/5ML, SOLUTION;ORAL - 5MG/5ML, TABLET;ORAL - 5MG, TABLET;ORAL - 7.5MG, TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 13.5MG, CAPSULE, EXTENDED RELEASE;ORAL - 18MG, CAPSULE, EXTENDED RELEASE;ORAL - 27MG, CAPSULE, EXTENDED RELEASE;ORAL - 36MG, CAPSULE, EXTENDED RELEASE;ORAL - 9MG, TABLET, EXTENDED RELEASE;ORAL - 10MG, TABLET, EXTENDED RELEASE;ORAL - 15MG, TABLET, EXTENDED RELEASE;ORAL - 20MG, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 40MG, TABLET, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 80MG, TABLET;ORAL - 325MG;5MG

CAPSULE;ORAL - 5MG
SOLUTION;ORAL - 100MG/5ML
SOLUTION;ORAL - 5MG/5ML
SOLUTION;ORAL - 5MG/5ML
TABLET;ORAL - 5MG
TABLET;ORAL - 7.5MG
TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 13.5MG
CAPSULE, EXTENDED RELEASE;ORAL - 18MG
CAPSULE, EXTENDED RELEASE;ORAL - 27MG
CAPSULE, EXTENDED RELEASE;ORAL - 36MG
CAPSULE, EXTENDED RELEASE;ORAL - 9MG
TABLET, EXTENDED RELEASE;ORAL - 10MG
TABLET, EXTENDED RELEASE;ORAL - 15MG
TABLET, EXTENDED RELEASE;ORAL - 20MG
TABLET, EXTENDED RELEASE;ORAL - 30MG
TABLET, EXTENDED RELEASE;ORAL - 40MG
TABLET, EXTENDED RELEASE;ORAL - 60MG
TABLET, EXTENDED RELEASE;ORAL - 80MG
TABLET;ORAL - 325MG;5MG

RELATED EXCIPIENT COMPANIES

4 Evonik, 7 Rochem International Inc, 22 SPI Pharma, 2 Seqens, 18 DKSH, 2 Jai Radhe Sales, 2 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 16 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 3 Pfanstiehl, 4 ACG Worldwide, 14 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 38 BASF, 1 Bioplus Life Sciences, 1 Clariant, 22 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 12 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 40 Roquette, 14 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 3 Valens Pharmachem, 5 Vasa Pharmachem, 1 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

113 Fillers, Diluents & Binders, 76 Coating Systems & Additives, 55 Controlled & Modified Release, 52 Direct Compression, 43 Thickeners and Stabilizers, 43 Disintegrants & Superdisintegrants, 39 Taste Masking, 36 Granulation, 34 Solubilizers, 30 Film Formers & Plasticizers, 28 Parenteral, 26 Lubricants & Glidants, 24 Co-Processed Excipients, 22 Chewable & Orodispersible Aids, 22 Topical, 9 Empty Capsules, 9 API Stability Enhancers, 9 Emulsifying Agents, 7 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

113 Fillers, Diluents & Binders
76 Coating Systems & Additives
55 Controlled & Modified Release
52 Direct Compression
43 Thickeners and Stabilizers
43 Disintegrants & Superdisintegrants
39 Taste Masking
36 Granulation
34 Solubilizers
30 Film Formers & Plasticizers
28 Parenteral
26 Lubricants & Glidants
24 Co-Processed Excipients
22 Chewable & Orodispersible Aids
22 Topical
9 Empty Capsules
9 API Stability Enhancers
9 Emulsifying Agents
7 Rheology Modifiers
5 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 290 NEWS #PharmaBuzz

5 DATA COMPILATION #PharmaFlow
290 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 273 Finished Drug Prices, 18 Annual Reports

4 US Medicaid Prescriptions
273 Finished Drug Prices
18 Annual Reports

MARKET PLACE

10 APIs, 9 FDF Dossiers

10 APIs
9 FDF Dossiers

PATENTS & EXCLUSIVITIES

225 US Patents, 4 US Exclusivities, 54 Health Canada Patents

225 US Patents
4 US Exclusivities
54 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 5 USP, 7 Others

2 EDQM
5 USP
7 Others

$ API Ref.Price (USD/KG) : 1,481 Xls

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01 3Camox Pharmaceuticals (Pty) Ltd

02 14Mundipharma (Pty) Ltd

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17 All

01 17Oxycodone Hydrochloride

filter Dosage Form Reset all filters

17 All

01 6CAP

02 2INJ

03 9SRT

filter Brand Name Reset all filters

17 All

01 1OxyNorm 10 mg Injection

02 1OxyNorm 20 mg Injection

03 1Oxycontin 10 mg Prolonged Release Tablets

04 1Oxycontin 20 mg Prolonged Release Tablets

05 1Oxycontin 40 mg Prolonged Release Tablets

06 1Oxycontin 5 mg Prolonged Release Tablets

07 1Oxycontin 80 mg Prolonged Release Tablets

08 1Oxycorrell 10mg

09 1Oxycorrell 20mg

10 1Oxycorrell 5mg

11 1Oxynorm 10 mg Capsules

12 1Oxynorm 20 mg Capsules

13 1Oxynorm 5 mg Capsules

14 1Targinact 10 mg / 5 mg

15 1Targinact 20 mg / 10 mg

16 1Targinact 40 mg / 20 mg

17 1Targinact 5 mg / 2.5 mg

Temad Oxycodone Hydrochloride

List of Suppliers

Product Main Page

01

Camox Pharmaceuticals (Pty) Ltd

American Pharma Summit

Not Confirmed

Camox Pharmaceuticals (Pty) Ltd

American Pharma Summit

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Regulatory Info : Generic

Registration Country : South Africa

Oxycodone Hydrochloride

Brand Name : Oxycorrell 5mg

Dosage Form : CAP

Dosage Strength : 5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

02

Camox Pharmaceuticals (Pty) Ltd

American Pharma Summit

Not Confirmed

Camox Pharmaceuticals (Pty) Ltd

American Pharma Summit

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Oxycodone Hydrochloride

Brand Name : Oxycorrell 10mg

Dosage Form : CAP

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

03

Camox Pharmaceuticals (Pty) Ltd

American Pharma Summit

Not Confirmed

Camox Pharmaceuticals (Pty) Ltd

American Pharma Summit

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Oxycodone Hydrochloride

Brand Name : Oxycorrell 20mg

Dosage Form : CAP

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

04

Mundipharma (Pty) Ltd

American Pharma Summit

Not Confirmed

Mundipharma (Pty) Ltd

American Pharma Summit

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Oxycodone Hydrochloride

Brand Name : Oxycontin 5 mg Prolonged Release Tablets

Dosage Form : SRT

Dosage Strength : 5mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Mundipharma (Pty) Ltd

American Pharma Summit

Not Confirmed

Mundipharma (Pty) Ltd

American Pharma Summit

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Oxycodone Hydrochloride

Brand Name : Oxycontin 10 mg Prolonged Release Tablets

Dosage Form : SRT

Dosage Strength : 10mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Mundipharma (Pty) Ltd

American Pharma Summit

Not Confirmed

Mundipharma (Pty) Ltd

American Pharma Summit

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Oxycodone Hydrochloride

Brand Name : Oxycontin 20 mg Prolonged Release Tablets

Dosage Form : SRT

Dosage Strength : 20mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Mundipharma (Pty) Ltd

American Pharma Summit

Not Confirmed

Mundipharma (Pty) Ltd

American Pharma Summit

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Oxycodone Hydrochloride

Brand Name : Oxycontin 40 mg Prolonged Release Tablets

Dosage Form : SRT

Dosage Strength : 40mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Mundipharma (Pty) Ltd

American Pharma Summit

Not Confirmed

Mundipharma (Pty) Ltd

American Pharma Summit

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Oxycodone Hydrochloride

Brand Name : Oxycontin 80 mg Prolonged Release Tablets

Dosage Form : SRT

Dosage Strength : 80mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Mundipharma (Pty) Ltd

American Pharma Summit

Not Confirmed

Mundipharma (Pty) Ltd

American Pharma Summit

Not Confirmed

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Regulatory Info : Originator

Registration Country : South Africa

Oxycodone Hydrochloride

Brand Name : Oxynorm 5 mg Capsules

Dosage Form : CAP

Dosage Strength : 5mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Mundipharma (Pty) Ltd

American Pharma Summit

Not Confirmed

Mundipharma (Pty) Ltd

American Pharma Summit

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Oxycodone Hydrochloride

Brand Name : Oxynorm 10 mg Capsules

Dosage Form : CAP

Dosage Strength : 10mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Product Web Link

Digital Content

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