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Drug Approvals by the Medicines Control Council in South Africa containing NCGC00024983-04. Original Data : South African Medicines Price Registry

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Product

NCGC00024983-04
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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NCGC00024983-04

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

58 API Suppliers, 38 USDMF, 9 CEP/COS, 7 JDMF, 4 EU WC, 7 KDMF, 19 NDC API, 18 Listed Suppliers, $ API Reference Price

58 API Suppliers
38 USDMF
9 CEP/COS
7 JDMF
4 EU WC
7 KDMF
19 NDC API
18 Listed Suppliers
$ API Reference Price

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

273 FDF Dossiers, 75 FDA Orange Book, 100 Europe, 18 Canada, 8 Australia, 32 South Africa, 40 Listed Dossiers

273 FDF Dossiers
75 FDA Orange Book
100 Europe
18 Canada
8 Australia
32 South Africa
40 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 10MG, CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 90MG, TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 10MG
CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 30MG
TABLET, EXTENDED RELEASE;ORAL - 60MG
TABLET, EXTENDED RELEASE;ORAL - 90MG
TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik, 2 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 12 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 26 BASF, 1 Clariant, 12 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 3 Finar, 8 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 24 Roquette, 10 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

81 Fillers, Diluents & Binders, 63 Coating Systems & Additives, 40 Controlled & Modified Release, 33 Direct Compression, 28 Thickeners and Stabilizers, 23 Film Formers & Plasticizers, 23 Granulation, 21 Parenteral, 21 Solubilizers, 20 Topical, 20 Taste Masking, 19 Co-Processed Excipients, 17 Lubricants & Glidants, 13 Disintegrants & Superdisintegrants, 9 Empty Capsules, 8 Chewable & Orodispersible Aids, 7 Emulsifying Agents, 6 Rheology Modifiers, 6 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

81 Fillers, Diluents & Binders
63 Coating Systems & Additives
40 Controlled & Modified Release
33 Direct Compression
28 Thickeners and Stabilizers
23 Film Formers & Plasticizers
23 Granulation
21 Parenteral
21 Solubilizers
20 Topical
20 Taste Masking
19 Co-Processed Excipients
17 Lubricants & Glidants
13 Disintegrants & Superdisintegrants
9 Empty Capsules
8 Chewable & Orodispersible Aids
7 Emulsifying Agents
6 Rheology Modifiers
6 API Stability Enhancers
5 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 106 Finished Drug Prices, 10 Annual Reports

2 US Medicaid Prescriptions
106 Finished Drug Prices
10 Annual Reports

MARKET PLACE

20 APIs, 16 FDF Dossiers

20 APIs
16 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 15 Others

3 EDQM
3 USP
15 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 81 Xls

Filters

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Filters

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32 All

01 1Pharmacare Limited, Woodmead

02 3Adcock Ingram Limited

03 8Bayer (Pty) Ltd

04 6Biotech Laboratories (Pty) Ltd

05 3Cipla Medpro (Pty) Ltd

06 2Litha Pharma (Pty) Ltd

07 2Pharma Dynamics (Pty) Ltd

08 3Sandoz SA (Pty) Ltd

09 4Specpharm (Pty) Ltd

filter Active Ingredients Reset all filters

32 All

01 32Nifedipine

filter Dosage Form Reset all filters

32 All

01 9CAP

02 2FCT

03 1SRC

04 1SRT

05 19TAB

filter Brand Name Reset all filters

32 All

01 1Adalat Retard 10Mg

02 1Adalat Retard 20

03 1Adalat Retard 20Mg

04 1Adalat XL 60

05 2Adalat XL 30

06 1Adco Vascard 20 SR

07 1Adco-Vascard 30 SR

08 1Adco-Vascard 60

09 1Bio Nifedipine XL 30

10 1Bio Nifedipine XL 60

11 1Bio-Nifedipine 10

12 1Bio-Nifedipine 5

13 1Cardifen

14 1Cardifen-10

15 1Cardifen-5

16 1Cipalat Retard

17 1Cipalat XR 30

18 1Cipalat XR 60

19 1Fedaloc 30Mg SR

20 1Fedaloc 60 mg SR

21 1Fidocare 30 XL

22 1Fidocare 60 XL

23 1Gitsalat 30

24 1Gitsalat 60

25 1Macorel 30 Sr

26 1Macorel 60 SR

27 1Nifedalat 10 mg

28 1Nifedalat 20 SR

29 1Rolab-Nifedipine

30 1Spec Nifedipine 30 Sr

31 1Spec Nifedipine 60 Sr

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Cardifen

Dosage Form : CAP

Dosage Strength : 10mg

Packaging : 250X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

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Product Web Link

Digital Content

Corporate PDF

02

Adcock Ingram Limited

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Adcock Ingram Limited

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Adco-Vascard 60

Dosage Form : CAP

Dosage Strength : 60mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Adcock Ingram Limited

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Adcock Ingram Limited

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Adco Vascard 20 SR

Dosage Form : CAP

Dosage Strength : 20mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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04

Adcock Ingram Limited

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Adcock Ingram Limited

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Adco-Vascard 30 SR

Dosage Form : SRC

Dosage Strength : 30mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Corporate PDF

05

Bayer (Pty) Ltd

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Bayer (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Adalat Retard 20Mg

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

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06

Bayer (Pty) Ltd

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Bayer (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Gitsalat 30

Dosage Form : TAB

Dosage Strength : 30mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Bayer (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Gitsalat 60

Dosage Form : TAB

Dosage Strength : 60mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Bayer (Pty) Ltd

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Bayer (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Adalat Retard 20

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

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09

Bayer (Pty) Ltd

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Bayer (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Adalat XL 30

Dosage Form : TAB

Dosage Strength : 30mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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10

Bayer (Pty) Ltd

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Bayer (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Adalat XL 30

Dosage Form : TAB

Dosage Strength : 30mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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