Nifedipine | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Nifedipine
South Africa

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

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Midas Pharma provides expertise in developing and supplying APIs, finished products, and intermediates.

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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

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xyz-pharma-m-2025-01-06

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Nifedipine

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

58 API Suppliers, 38 USDMF, 11 CEP/COS, 7 JDMF, 6 EU WC, 7 KDMF, 18 NDC API, 17 Listed Suppliers, $ API Reference Price

58 API Suppliers
38 USDMF
11 CEP/COS
7 JDMF
6 EU WC
7 KDMF
18 NDC API
17 Listed Suppliers
$ API Reference Price

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

272 FDF Dossiers, 75 FDA Orange Book, 100 Europe, 18 Canada, 4 Australia, 31 South Africa, 44 Listed Dossiers

272 FDF Dossiers
75 FDA Orange Book
100 Europe
18 Canada
4 Australia
31 South Africa
44 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CAPSULE;ORAL - 10MG, CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 90MG, TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 90MG **Federal Register determination that product was not discontinued or withdrawn for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, 6 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 5 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, 1 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, 32 Direct Compression, 28 Thickeners and Stabilizers, 23 Film Formers & Plasticizers, 23 Granulation, 21 Parenteral, 20 Taste Masking, 20 Solubilizers, 20 Topical, 19 Co-Processed Excipients, 17 Lubricants & Glidants, 12 Disintegrants & Superdisintegrants, 9 Empty Capsules, 8 Chewable & Orodispersible Aids, 7 Emulsifying Agents, 6 API Stability Enhancers, 6 Rheology Modifiers, 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
32 Direct Compression
28 Thickeners and Stabilizers
23 Film Formers & Plasticizers
23 Granulation
21 Parenteral
20 Taste Masking
20 Solubilizers
20 Topical
19 Co-Processed Excipients
17 Lubricants & Glidants
12 Disintegrants & Superdisintegrants
9 Empty Capsules
8 Chewable & Orodispersible Aids
7 Emulsifying Agents
6 API Stability Enhancers
6 Rheology Modifiers
5 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 19 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
19 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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31 All

01 1Pharmacare Limited, Woodmead

02 3Adcock Ingram Limited

03 7Bayer (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

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31 All

01 31Nifedipine

filter Dosage Form Reset all filters

31 All

01 9CAP

02 2FCT

03 1SRC

04 1SRT

05 18TAB

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31 All

01 1Adalat Retard 10Mg

02 2Adalat Retard 20Mg

03 1Adalat Xl Tabs 30Mg 28S

04 1Adalat Xl Tabs 60Mg 28S

05 1Adco Vascard 20 Sr

06 1Adco-Vascard 30 SR

07 1Adco-Vascard 60

08 1Bio Nifedipine XL 30

09 1Bio Nifedipine XL 60

10 1Bio-Nifedipine 10

11 1Bio-Nifedipine 5

12 1Cardifen

13 1Cardifen-10

14 1Cardifen-5

15 1Cipalat Retard

16 1Cipalat XR 30

17 1Cipalat XR 60

18 1Fedaloc 30Mg SR

19 1Fedaloc 60 mg SR

20 1Fidocare 30 XL

21 1Fidocare 60 XL

22 1Gitsalat 30

23 1Gitsalat 60

24 1Macorel 30 Sr

25 1Macorel 60 SR

26 1Nifedalat 10 mg

27 1Nifedalat 20 SR

28 1Rolab-Nifedipine

29 1Spec Nifedipine 30 Sr

30 1Spec Nifedipine 60 Sr

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

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Digital Content

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

Portfolio PDF

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

Portfolio PDF

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03

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 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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Digital Content

Corporate PDF

04

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 30 SR

Dosage Form : SRC

Dosage Strength : 30mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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Corporate PDF

05

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 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

Portfolio PDF

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07

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 60

Dosage Form : TAB

Dosage Strength : 60mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

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08

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 Retard 20Mg

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

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 Tabs 30Mg 28S

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

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 Tabs 60Mg 28S

Dosage Form : TAB

Dosage Strength : 60mg

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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