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Drug Approvals by the Medicines Control Council in South Africa containing NCGC00024710-03. Original Data : South African Medicines Price Registry

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NCGC00024710-03
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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NCGC00024710-03

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 17 USDMF, 10 CEP/COS, 1 JDMF, 6 EU WC, 2 KDMF, 14 NDC API, 14 Listed Suppliers, $ API Reference Price

31 API Suppliers
17 USDMF
10 CEP/COS
1 JDMF
6 EU WC
2 KDMF
14 NDC API
14 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

3 API Suppliers

3 API Suppliers

FINISHED DOSAGE FORMULATIONS

150 FDF Dossiers, 114 FDA Orange Book, 12 Europe, 8 Canada, 6 South Africa, 10 Listed Dossiers

150 FDF Dossiers
114 FDA Orange Book
12 Europe
8 Canada
6 South Africa
10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 120MG, CAPSULE, EXTENDED RELEASE;ORAL - 180MG, CAPSULE, EXTENDED RELEASE;ORAL - 240MG, CAPSULE, EXTENDED RELEASE;ORAL - 360MG, CAPSULE, EXTENDED RELEASE;ORAL - 100MG, CAPSULE, EXTENDED RELEASE;ORAL - 200MG, CAPSULE, EXTENDED RELEASE;ORAL - 300MG

TABLET;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 120MG
CAPSULE, EXTENDED RELEASE;ORAL - 180MG
CAPSULE, EXTENDED RELEASE;ORAL - 240MG
CAPSULE, EXTENDED RELEASE;ORAL - 360MG
CAPSULE, EXTENDED RELEASE;ORAL - 100MG
CAPSULE, EXTENDED RELEASE;ORAL - 200MG
CAPSULE, EXTENDED RELEASE;ORAL - 300MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 3 Evonik, 2 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 8 DKSH, 3 Jai Radhe Sales, 1 Pharm-RX Chemical, 5 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 10 Actylis, 1 Aeon Procare, 3 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 34 BASF, 1 Bioplus Life Sciences, 1 Clariant, 16 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 2 Finar, 13 Gangwal Chemicals, 16 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 38 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 12 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 3 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

83 Fillers, Diluents & Binders, 76 Coating Systems & Additives, 48 Disintegrants & Superdisintegrants, 48 Controlled & Modified Release, 44 Direct Compression, 34 Solubilizers, 34 Thickeners and Stabilizers, 32 Granulation, 22 Taste Masking, 22 Lubricants & Glidants, 18 Parenteral, 17 Co-Processed Excipients, 17 Topical, 16 Film Formers & Plasticizers, 12 Chewable & Orodispersible Aids, 9 Empty Capsules, 9 Emulsifying Agents, 6 API Stability Enhancers, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

83 Fillers, Diluents & Binders
76 Coating Systems & Additives
48 Disintegrants & Superdisintegrants
48 Controlled & Modified Release
44 Direct Compression
34 Solubilizers
34 Thickeners and Stabilizers
32 Granulation
22 Taste Masking
22 Lubricants & Glidants
18 Parenteral
17 Co-Processed Excipients
17 Topical
16 Film Formers & Plasticizers
12 Chewable & Orodispersible Aids
9 Empty Capsules
9 Emulsifying Agents
6 API Stability Enhancers
5 Coloring Agents
5 Rheology Modifiers
4 Vegetarian Capsules
4 Surfactant & Foaming Agents

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

1 US Medicaid Prescriptions
26 Finished Drug Prices

MARKET PLACE

14 APIs, 1 FDF Dossiers

14 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 1 USP, 1 Others

4 EDQM
1 USP
1 Others

$ API Ref.Price (USD/KG) : 94 Xls

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6 All

01 5Abbott Laboratories SA (Pty) Ltd

02 1Sandoz SA (Pty) Ltd

filter Active Ingredients Reset all filters

6 All

01 1Verapamil HCL

02 4Verapamil HCl

03 1Verapamil Hydrochloride

filter Dosage Form Reset all filters

6 All

01 1SRC

02 1SRT

03 4TAB

filter Brand Name Reset all filters

6 All

01 1Tarka

02 2Tarka 180/2

03 2Tarka 240/4

04 1Verahexal 240 Sr

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Abbott Laboratories SA (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Verapamil HCl

Brand Name : Tarka 180/2

Dosage Form : TAB

Dosage Strength : 180mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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02

Abbott Laboratories SA (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Verapamil HCl

Brand Name : Tarka 180/2

Dosage Form : TAB

Dosage Strength : 180mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

Abbott Laboratories SA (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Verapamil HCl

Brand Name : Tarka 240/4

Dosage Form : TAB

Dosage Strength : 240mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

Abbott Laboratories SA (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Verapamil HCl

Brand Name : Tarka 240/4

Dosage Form : TAB

Dosage Strength : 240mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Abbott Laboratories SA (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Verapamil HCL

Brand Name : Tarka

Dosage Form : SRC

Dosage Strength : 180mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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06

Sandoz SA (Pty) Ltd

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Sandoz SA (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Verapamil Hydrochloride

Brand Name : Verahexal 240 Sr

Dosage Form : SRT

Dosage Strength : 240mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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