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

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Vardenafil Hydrochloride
South Africa

Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

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xyz-pharma-m-2025-06-09

Vardenafil Hydrochloride

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ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 6 USDMF, 5 CEP/COS, 2 JDMF, 2 EU WC, 2 KDMF, 14 NDC API, 21 Listed Suppliers, $ API Reference Price

31 API Suppliers
6 USDMF
5 CEP/COS
2 JDMF
2 EU WC
2 KDMF
14 NDC API
21 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

111 FDF Dossiers, 32 FDA Orange Book, 39 Europe, 12 Canada, 8 South Africa, 20 Listed Dossiers

111 FDF Dossiers
32 FDA Orange Book
39 Europe
12 Canada
8 South Africa
20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, ORALLY DISINTEGRATING;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, ORALLY DISINTEGRATING;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 15 SPI Pharma, 5 DKSH, 2 Faran Shimi Pharmaceutical, 4 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 3 Actylis, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 17 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 21 Roquette, 6 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 8 Sigachi Industries, 2 Silverline Chemicals, 2 The Dow Chemical Company, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 40 Fillers, Diluents & Binders, 23 Controlled & Modified Release, 18 Direct Compression, 17 Taste Masking, 17 Thickeners and Stabilizers, 15 Co-Processed Excipients, 15 Chewable & Orodispersible Aids, 14 Film Formers & Plasticizers, 11 Granulation, 10 Lubricants & Glidants, 9 Disintegrants & Superdisintegrants, 7 Topical, 6 Parenteral, 6 Solubilizers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Coloring Agents, 4 Emulsifying Agents, 4 Rheology Modifiers, 1 Soft Gelatin

45 Coating Systems & Additives
40 Fillers, Diluents & Binders
23 Controlled & Modified Release
18 Direct Compression
17 Taste Masking
17 Thickeners and Stabilizers
15 Co-Processed Excipients
15 Chewable & Orodispersible Aids
14 Film Formers & Plasticizers
11 Granulation
10 Lubricants & Glidants
9 Disintegrants & Superdisintegrants
7 Topical
6 Parenteral
6 Solubilizers
5 Empty Capsules
4 Vegetarian Capsules
4 API Stability Enhancers
4 Coloring Agents
4 Emulsifying Agents
4 Rheology Modifiers
1 Soft Gelatin

DIGITAL CONTENT

19 News #PharmaBuzz

19 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 26 Regulatory FDF Prices, 2 Annual Reports

1 US Medicaid Prescriptions
26 Regulatory FDF Prices
2 Annual Reports

MARKET PLACE

12 APIs

12 APIs

PATENTS & EXCLUSIVITIES

5 US Patents, 5 Health Canada Patents

5 US Patents
5 Health Canada Patents

REF. STANDARDS & IMPURITIES

11 Others

11 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 1,535 Xls

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filter Applicant Reset all filters

8 All

01 3Bayer (Pty) Ltd

02 3Bayer AG

03 2Macleods Pharmaceuticals SA (Pty) Ltd

filter Active Ingredients Reset all filters

8 All

01 6Vardenafil

02 2vardenafil

filter Dosage Form Reset all filters

8 All

01 2FCT

02 6TAB

filter Brand Name Reset all filters

8 All

01 1Levitra 5

02 2Levitra 10

03 2Levitra 20

04 1Levitra ODT 10

05 1VARFYDO 10 MG FC

06 1VARFYDO 20 MG FC

List of Suppliers

Product Main Page

01

Bayer AG

Simposio AFI

Not Confirmed

Bayer AG

Simposio AFI

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Levitra 5

Dosage Form : TAB

Dosage Strength : 5mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Bayer AG

Simposio AFI

Not Confirmed

Bayer AG

Simposio AFI

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Levitra 10

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 2X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Bayer AG

Simposio AFI

Not Confirmed

Bayer AG

Simposio AFI

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Levitra 10

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Bayer (Pty) Ltd

Simposio AFI

Not Confirmed

Bayer (Pty) Ltd

Simposio AFI

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Levitra 20

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Bayer (Pty) Ltd

Simposio AFI

Not Confirmed

Bayer (Pty) Ltd

Simposio AFI

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Levitra 20

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 2X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Bayer (Pty) Ltd

Simposio AFI

Not Confirmed

Bayer (Pty) Ltd

Simposio AFI

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Levitra ODT 10

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Macleods Pharmaceuticals SA (Pty) Ltd

Simposio AFI

Not Confirmed

Macleods Pharmaceuticals SA (Pty) Ltd

Simposio AFI

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : VARFYDO 10 MG FC

Dosage Form : FCT

Dosage Strength : 10mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Macleods Pharmaceuticals SA (Pty) Ltd

Simposio AFI

Not Confirmed

Macleods Pharmaceuticals SA (Pty) Ltd

Simposio AFI

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 : Generic

Registration Country : South Africa

Brand Name : VARFYDO 20 MG FC

Dosage Form : FCT

Dosage Strength : 20mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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