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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Fentanyl Citrate

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 14 USDMF, 12 CEP/COS, 3 JDMF, 3 EU WC, 4 KDMF, 16 NDC API, 17 Listed Suppliers, $ API Reference Price

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

FINISHED DOSAGE FORMULATIONS

279 FDF Dossiers, 77 FDA Orange Book, 159 Europe, 14 Canada, 3 South Africa, 26 Listed Dossiers

279 FDF Dossiers
77 FDA Orange Book
159 Europe
14 Canada
3 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BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE, TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for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, 17 SPI Pharma, 1 Jai Radhe Sales, 2 Boai NKY Pharmaceuticals Ltd, 11 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

59 Fillers, Diluents & Binders, 42 Coating Systems & Additives, 34 Direct Compression, 28 Disintegrants & Superdisintegrants, 23 Controlled & Modified Release, 18 Thickeners and Stabilizers, 17 Taste Masking, 16 Granulation, 15 Chewable & Orodispersible Aids, 14 Co-Processed Excipients, 11 Lubricants & Glidants, 11 Film Formers & Plasticizers, 9 Parenteral, 5 Solubilizers, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 3 Emulsifying Agents, 3 Topical, 3 Rheology Modifiers, 2 Coloring Agents

59 Fillers, Diluents & Binders
42 Coating Systems & Additives
34 Direct Compression
28 Disintegrants & Superdisintegrants
23 Controlled & Modified Release
18 Thickeners and Stabilizers
17 Taste Masking
16 Granulation
15 Chewable & Orodispersible Aids
14 Co-Processed Excipients
11 Lubricants & Glidants
11 Film Formers & Plasticizers
9 Parenteral
5 Solubilizers
5 Empty Capsules
5 API Stability Enhancers
4 Vegetarian Capsules
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

11 APIs, 5 FDF Dossiers

11 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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01 3Teva Pharmaceuticals (Pty) Ltd

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01 3FENTANYL CITRATE

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01 3EFT

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01 1EFFENTORA 100

02 1EFFENTORA 200

03 1EFFENTORA 400

Aspen Fentanyl Citrate

List of Suppliers

Product Main Page

01

Teva Pharmaceuticals (Pty) Ltd

PackExpo

Not Confirmed

Teva Pharmaceuticals (Pty) Ltd

PackExpo

Not Confirmed

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Regulatory Info : Originator

Registration Country : South Africa

FENTANYL CITRATE

Brand Name : EFFENTORA 100

Dosage Form : EFT

Dosage Strength : 100ug

Packaging : 28X1ug

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Teva Pharmaceuticals (Pty) Ltd

PackExpo

Not Confirmed

Teva Pharmaceuticals (Pty) Ltd

PackExpo

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

FENTANYL CITRATE

Brand Name : EFFENTORA 200

Dosage Form : EFT

Dosage Strength : 200ug

Packaging : 28X1ug

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Teva Pharmaceuticals (Pty) Ltd

PackExpo

Not Confirmed

Teva Pharmaceuticals (Pty) Ltd

PackExpo

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

FENTANYL CITRATE

Brand Name : EFFENTORA 400

Dosage Form : EFT

Dosage Strength : 400ug

Packaging : 28X1ug

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Digital Content

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