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

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Fentanyl Citrate
South Africa

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pharmacompass-2-m-2025-11-03

Fentanyl Citrate

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

39 API Suppliers, 13 USDMF, 12 CEP/COS, 4 JDMF, 2 EU WC, 4 KDMF, 15 NDC API, 16 Listed Suppliers, $ API Reference Price

39 API Suppliers
13 USDMF
12 CEP/COS
4 JDMF
2 EU WC
4 KDMF
15 NDC API
16 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

7 Drugs in Development

7 Drugs in Development

FINISHED DOSAGE FORMULATIONS

495 FDF Dossiers, 77 FDA Orange Book, 374 Europe, 13 Canada, 3 South Africa, 28 Listed Dossiers

495 FDF Dossiers
77 FDA Orange Book
374 Europe
13 Canada
3 South Africa
28 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BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE, TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for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, 2 DKSH, 2 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 5 Kirsch Pharma, 1 ACG Worldwide, 6 Actylis, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 BASF, 1 CD Formulation, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Finar, 5 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 4 Ideal Cures, 5 Ingredion Pharma Solutions, 11 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 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, 4 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

55 Fillers, Diluents & Binders, 38 Coating Systems & Additives, 30 Disintegrants & Superdisintegrants, 27 Direct Compression, 21 Thickeners and Stabilizers, 19 Taste Masking, 18 Chewable & Orodispersible Aids, 17 Controlled & Modified Release, 16 Granulation, 13 Parenteral, 12 Co-Processed Excipients, 10 Lubricants & Glidants, 9 Film Formers & Plasticizers, 6 Solubilizers, 5 Empty Capsules, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Emulsifying Agents, 3 Topical, 2 Coloring Agents

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

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 36 News #PharmaBuzz

1 Data Compilation #PharmaFlow
36 News #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 34 Regulatory FDF Prices, 8 Annual Reports

6 US Medicaid Prescriptions
34 Regulatory FDF Prices
8 Annual Reports

MARKET PLACE

13 APIs, 5 FDF Dossiers

13 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

18 US Patents, 17 Health Canada Patents

18 US Patents
17 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 3 Others

2 EDQM
3 Others

$ API Ref.Price (USD/KG) : 28,748 Xls

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01 3FENTANYL CITRATE

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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

BOS Manchester

Not Confirmed

Teva Pharmaceuticals (Pty) Ltd

BOS Manchester

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

CPhI India

Not Confirmed

Teva Pharmaceuticals (Pty) Ltd

CPhI India

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

CPhI India

Not Confirmed

Teva Pharmaceuticals (Pty) Ltd

CPhI India

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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Product Web Link

Digital Content

Corporate PDF

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