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Drug Approvals by the Medicines Control Council in South Africa containing Vardenafil HCl. Original Data : South African Medicines Price Registry

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Product

Vardenafil HCl
South Africa

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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Vardenafil HCl

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 6 USDMF, 5 CEP/COS, 2 JDMF, 8 EU WC, 2 KDMF, 13 NDC API, 21 Listed Suppliers, $ API Reference Price

27 API Suppliers
6 USDMF
5 CEP/COS
2 JDMF
8 EU WC
2 KDMF
13 NDC API
21 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

102 FDF Dossiers, 32 FDA Orange Book, 39 Europe, 6 Canada, 5 South Africa, 20 Listed Dossiers

102 FDF Dossiers
32 FDA Orange Book
39 Europe
6 Canada
5 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TABLET, ORALLY DISINTEGRATING;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or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, 14 SPI Pharma, 2 Seqens, 3 DKSH, 7 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 The Dow Chemical Company, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 42 Fillers, Diluents & Binders, 24 Controlled & Modified Release, 22 Direct Compression, 17 Thickeners and Stabilizers, 16 Taste Masking, 14 Chewable & Orodispersible Aids, 14 Film Formers & Plasticizers, 11 Granulation, 11 Lubricants & Glidants, 11 Co-Processed Excipients, 8 Parenteral, 7 Topical, 6 Disintegrants & Superdisintegrants, 5 Empty Capsules, 5 API Stability Enhancers, 5 Solubilizers, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Emulsifying Agents, 2 Rheology Modifiers, 1 Soft Gelatin

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

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 26 Finished Drug Prices, 2 Annual Reports

1 US Medicaid Prescriptions
26 Finished Drug 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

2 USP, 11 Others

2 USP
11 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 2,164 Xls

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filter Applicant Reset all filters

5 All

01 3Bayer (Pty) Ltd

02 2Macleods Pharmaceuticals SA (Pty) Ltd

filter Active Ingredients Reset all filters

5 All

01 3Vardenafil

02 2vardenafil

filter Dosage Form Reset all filters

5 All

01 2FCT

02 3TAB

filter Brand Name Reset all filters

5 All

01 2Levitra 20

02 1Levitra ODT 10

03 1VARFYDO 10 MG FC

04 1VARFYDO 20 MG FC

FDF Dossiers
FDA Orange Book
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Canada
South Africa
Listed Dossiers

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01

Bayer (Pty) Ltd

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Bayer (Pty) Ltd

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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

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02

Bayer (Pty) Ltd

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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

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03

Bayer (Pty) Ltd

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Bayer (Pty) Ltd

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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

04

Macleods Pharmaceuticals SA (Pty) Ltd

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Macleods Pharmaceuticals SA (Pty) Ltd

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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

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05

Macleods Pharmaceuticals SA (Pty) Ltd

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Macleods Pharmaceuticals SA (Pty) Ltd

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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

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