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

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Ezetimibe
South Africa

munit-sa-m-2025-04-14

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

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SPI Pharma has been solving formulation challenges using superior functional materials.

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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Suanfarma, at the Core of a Better Life.

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xyz-pharma-m-2025-04-14

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Ezetimibe

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

120 API Suppliers, 29 USDMF, 11 JDMF, 17 EU WC, 64 KDMF, 18 NDC API, 49 Listed Suppliers, $ API Reference Price

120 API Suppliers
29 USDMF
11 JDMF
17 EU WC
64 KDMF
18 NDC API
49 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

20 Drugs in Development

20 Drugs in Development

INTERMEDIATES

33 Intermediate Suppliers

33 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

618 FDF Dossiers, 70 FDA Orange Book, 356 Europe, 22 Canada, 23 Australia, 43 South Africa, 104 Listed Dossiers

618 FDF Dossiers
70 FDA Orange Book
356 Europe
22 Canada
23 Australia
43 South Africa
104 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 10MG, TABLET;ORAL - 10MG;10MG, TABLET;ORAL - 10MG;20MG, TABLET;ORAL - 10MG;40MG, TABLET;ORAL - 10MG;80MG

TABLET;ORAL - EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 10MG
TABLET;ORAL - 10MG;10MG
TABLET;ORAL - 10MG;20MG
TABLET;ORAL - 10MG;40MG
TABLET;ORAL - 10MG;80MG

RELATED EXCIPIENT COMPANIES

2 Minakem, 6 SPI Pharma, 6 DKSH, 6 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 6 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pramukh Pharmachem, 1 Zeal MediPharma, 1 ACG Worldwide, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 10 Corel Pharma Chem, 7 DFE Pharma, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 NEWEDGE Overseas, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 6 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 12 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

65 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 40 Disintegrants & Superdisintegrants, 29 Direct Compression, 27 Granulation, 24 Controlled & Modified Release, 21 Lubricants & Glidants, 19 Thickeners and Stabilizers, 11 Co-Processed Excipients, 10 Chewable & Orodispersible Aids, 9 Taste Masking, 9 Solubilizers, 9 Film Formers & Plasticizers, 6 API Stability Enhancers, 5 Coloring Agents, 5 Rheology Modifiers, 5 Empty Capsules, 4 Emulsifying Agents, 4 Parenteral, 4 Vegetarian Capsules, 2 Topical, 1 Surfactant & Foaming Agents

65 Fillers, Diluents & Binders
47 Coating Systems & Additives
40 Disintegrants & Superdisintegrants
29 Direct Compression
27 Granulation
24 Controlled & Modified Release
21 Lubricants & Glidants
19 Thickeners and Stabilizers
11 Co-Processed Excipients
10 Chewable & Orodispersible Aids
9 Taste Masking
9 Solubilizers
9 Film Formers & Plasticizers
6 API Stability Enhancers
5 Coloring Agents
5 Rheology Modifiers
5 Empty Capsules
4 Emulsifying Agents
4 Parenteral
4 Vegetarian Capsules
2 Topical
1 Surfactant & Foaming Agents

DIGITAL CONTENT

111 News #PharmaBuzz

111 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 329 Regulatory FDF Prices, 38 Annual Reports

3 US Medicaid Prescriptions
329 Regulatory FDF Prices
38 Annual Reports

MARKET PLACE

20 APIs, 5 FDF Dossiers

20 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

19 US Patents, 3 US Exclusivities, 2 Health Canada Patents

19 US Patents
3 US Exclusivities
2 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 2 Others

2 USP
2 Others

ANALYTICAL

6 BioAnalytical Methods

6 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 1,302 Xls

Filters

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43 All

01 3Pharmacare Limited, Woodmead

02 2Abbott Laboratories SA (Pty) Ltd

03 1Accord Healthcare (Pty) Ltd

04 1Adcock Ingram Limited

05 6Ascend Laboratories (Pty) Ltd

06 1Austell Pharmaceuticals (Pty) Ltd

07 4Cipla Medpro (Pty) Ltd

08 4Forrester Pharma (Pty) Ltd

09 7Organon South Africa (Pty) Ltd

10 4Pharma Dynamics (Pty) Ltd

11 4Ranbaxy Pharmaceuticals (Pty) Ltd

12 2Sandoz SA (Pty) Ltd

13 1Teva Pharmaceuticals (Pty) Ltd

14 2Trinity Pharma (Pty) Ltd

15 1Zydus Healthcare SA (Pty) Ltd

filter Active Ingredients Reset all filters

43 All

01 3EZETIMIBE

02 40Ezetimibe

filter Dosage Form Reset all filters

43 All

01 7FCT

02 33TAB

03 1TABS

04 2Tab

filter Brand Name Reset all filters

43 All

01 1EZETIMIBE 10 TEVA

02 1Ezentia

03 1Ezesim 10/10

04 1Ezesim 10/20

05 1Ezesim 10/40

06 1Ezetimibe 10 Unicorn

07 1Ezetimibe simvastatin 10mg/10 mg Alkem

08 1Ezetimibe simvastatin 10mg/20 mg Alkem

09 1Ezetimibe simvastatin 10mg/40 mg Alkem

10 1Ezetrol

11 1Ezimva 10/10

12 1Ezimva 10/20

13 1Ezimva 10/40

14 1Ezorb

15 1INEGY 10/10

16 1INEGY 10/20

17 1INEGY 10/40

18 1Liptruzet 10/10

19 1Liptruzet 10/20

20 1Liptruzet 10/40

21 1Lypstaplus 10 mg/10 mg

22 1Lypstaplus 20 mg/10 mg

23 1MEZIBE 10

24 1MEZIBE PLUS 10/10

25 1MEZIBE PLUS 10/20

26 1MEZIBE PLUS 10/40

27 1Mibitez

28 1Nitasol

29 1Reguchole 10/10mg

30 1Reguchole 10/20mg

31 1Reguchole 10/5mg

32 1Rosuzet 10 mg/10 mg

33 1Rosuzet 20 mg/10 mg

34 1Rosuzet 40 mg/10 mg

35 1Rosuzet 5 mg/10 mg

36 1Tactus 10mg

37 1Toleze 10

38 1Trezecol 10mg

39 1Tryzetor

40 1Tryzetor Plus 10/10 mg

41 1Tryzetor Plus 10/20 mg

42 1Tryzetor Plus 10/40 mg

43 1Zytezo

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

Drug Discovery Chemistry

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Reguchole 10/5mg

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

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

Pharmacare Limited, Woodmead

Drug Discovery Chemistry

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Reguchole 10/10mg

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Pharmacare Limited, Woodmead

Drug Discovery Chemistry

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Reguchole 10/20mg

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

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04

Abbott Laboratories SA (Pty) Ltd

Drug Discovery Chemistry

Not Confirmed

Abbott Laboratories SA (Pty) Ltd

Drug Discovery Chemistry

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Lypstaplus 20 mg/10 mg

Dosage Form : Tab

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Abbott Laboratories SA (Pty) Ltd

Drug Discovery Chemistry

Not Confirmed

Abbott Laboratories SA (Pty) Ltd

Drug Discovery Chemistry

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Lypstaplus 10 mg/10 mg

Dosage Form : Tab

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

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Corporate PDF

06

Accord Healthcare (Pty) Ltd

Drug Discovery Chemistry

Not Confirmed

Accord Healthcare (Pty) Ltd

Drug Discovery Chemistry

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Trezecol 10mg

Dosage Form : TABS

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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07

Adcock Ingram Limited

Drug Discovery Chemistry

Not Confirmed

Adcock Ingram Limited

Drug Discovery Chemistry

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Toleze 10

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Corporate PDF

08

Ascend Laboratories (Pty) Ltd

Drug Discovery Chemistry

Not Confirmed

Ascend Laboratories (Pty) Ltd

Drug Discovery Chemistry

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Ezetimibe simvastatin 10mg/10 mg Alkem

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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09

Ascend Laboratories (Pty) Ltd

Drug Discovery Chemistry

Not Confirmed

Ascend Laboratories (Pty) Ltd

Drug Discovery Chemistry

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Ezetimibe simvastatin 10mg/20 mg Alkem

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Ascend Laboratories (Pty) Ltd

Drug Discovery Chemistry

Not Confirmed

Ascend Laboratories (Pty) Ltd

Drug Discovery Chemistry

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Ezetimibe simvastatin 10mg/40 mg Alkem

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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