Fentanyl Citrate | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Fentanyl Citrate
South Africa

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Veranova Fentanyl Citrate

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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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Fentanyl Citrate

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 14 USDMF, 12 CEP/COS, 4 JDMF, 3 EU WC, 4 KDMF, 16 NDC API, 16 Listed Suppliers, $ API Reference Price

31 API Suppliers
14 USDMF
12 CEP/COS
4 JDMF
3 EU WC
4 KDMF
16 NDC API
16 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

379 FDF Dossiers, 77 FDA Orange Book, 159 Europe, 25 Canada, 75 Australia, 17 South Africa, 26 Listed Dossiers

379 FDF Dossiers
77 FDA Orange Book
159 Europe
25 Canada
75 Australia
17 South Africa
26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE, TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE
TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE
TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE
TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE
TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE
TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE
TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE
TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE
TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE
TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE
TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE
TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 18 SPI Pharma, 4 Faran Shimi Pharmaceutical, 2 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 BASF, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Finar, 5 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 17 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 8 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

56 Fillers, Diluents & Binders, 42 Coating Systems & Additives, 30 Disintegrants & Superdisintegrants, 27 Direct Compression, 22 Controlled & Modified Release, 18 Taste Masking, 17 Thickeners and Stabilizers, 16 Granulation, 16 Chewable & Orodispersible Aids, 13 Co-Processed Excipients, 11 Film Formers & Plasticizers, 10 Lubricants & Glidants, 9 Parenteral, 6 Solubilizers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Emulsifying Agents, 3 Topical, 3 Rheology Modifiers, 2 Coloring Agents

56 Fillers, Diluents & Binders
42 Coating Systems & Additives
30 Disintegrants & Superdisintegrants
27 Direct Compression
22 Controlled & Modified Release
18 Taste Masking
17 Thickeners and Stabilizers
16 Granulation
16 Chewable & Orodispersible Aids
13 Co-Processed Excipients
11 Film Formers & Plasticizers
10 Lubricants & Glidants
9 Parenteral
6 Solubilizers
5 Empty Capsules
4 Vegetarian Capsules
4 API Stability Enhancers
3 Emulsifying Agents
3 Topical
3 Rheology Modifiers
2 Coloring Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 35 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
35 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 103 Finished Drug Prices

2 US Medicaid Prescriptions
103 Finished Drug Prices

MARKET PLACE

12 APIs, 5 FDF Dossiers

12 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

36 US Patents, 17 Health Canada Patents

36 US Patents
17 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 3 Others

2 EDQM
1 USP
3 Others

$ API Ref.Price (USD/KG) : 64,860 Xls

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17 All

01 4Adcock Ingram Limited

02 5Janssen Pharmaceutica (Pty) Ltd

03 2Pharma-Q Holdings (Pty) Ltd

04 2Piramal Critical Care South Africa (Pty) Ltd

05 4Sandoz SA (Pty) Ltd

filter Active Ingredients Reset all filters

17 All

01 17Fentanyl

filter Dosage Form Reset all filters

17 All

01 4INJ

02 5PAD

03 8PTD

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17 All

01 1Adco Tenyl 100µg/h

02 1Adco Tenyl 25µg/h

03 1Adco Tenyl 50µg/h

04 1Adco Tenyl 75µg/h

05 1Durogesic 100Mcg Per Hour

06 1Durogesic 12Mcg Per Hour

07 1Durogesic 25Mcg Per Hour

08 1Durogesic 50Mcg Per Hour

09 1Durogesic 75Mcg Per Hour

10 1Fendermal 100µg/h

11 1Fendermal 25µg/h

12 1Fendermal 50µg/h

13 1Fendermal 75µg/h

14 1Pharma-Q Fentanyl 100mcg/2 ml Injection

15 1Pharma-Q Fentanyl 500mcg/10ml Injection

16 1Sublimaze 10ml

17 1Sublimaze 2ml

Aspen Fentanyl Citrate

List of Suppliers

Product Main Page

01

Adcock Ingram Limited

PharmScience R&D

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Adcock Ingram Limited

PharmScience R&D

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Adco Tenyl 25µg/h

Dosage Form : PTD

Dosage Strength : 25µg/h

Packaging : 5X1µg/h

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Adcock Ingram Limited

PharmScience R&D

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Adcock Ingram Limited

PharmScience R&D

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Adco Tenyl 50µg/h

Dosage Form : PTD

Dosage Strength : 50µg/h

Packaging : 5X1µg/h

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Adcock Ingram Limited

PharmScience R&D

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Adcock Ingram Limited

PharmScience R&D

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Adco Tenyl 75µg/h

Dosage Form : PTD

Dosage Strength : 75µg/h

Packaging : 5X1µg/h

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Adcock Ingram Limited

PharmScience R&D

Not Confirmed

Adcock Ingram Limited

PharmScience R&D

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Adco Tenyl 100µg/h

Dosage Form : PTD

Dosage Strength : 100µg/h

Packaging : 5X1µg/h

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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05

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Durogesic 12Mcg Per Hour

Dosage Form : PAD

Dosage Strength : 12mcg

Packaging : 5X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Durogesic 25Mcg Per Hour

Dosage Form : PAD

Dosage Strength : 25mcg

Packaging : 5X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Durogesic 50Mcg Per Hour

Dosage Form : PAD

Dosage Strength : 50mcg

Packaging : 5X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Durogesic 100Mcg Per Hour

Dosage Form : PAD

Dosage Strength : 100mcg

Packaging : 5X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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09

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

Not Confirmed

Janssen Pharmaceutica (Pty) Ltd

PharmScience R&D

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Durogesic 75Mcg Per Hour

Dosage Form : PAD

Dosage Strength : 75mcg

Packaging : 5X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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10

Pharma-Q Holdings (Pty) Ltd

Country

PharmScience R&D

Not Confirmed

Pharma-Q Holdings (Pty) Ltd

Country

PharmScience R&D

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Pharma-Q Fentanyl 100mcg/2 ml Injection

Dosage Form : INJ

Dosage Strength : 100mcg/2ml

Packaging : 10X1mcg/2ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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