EXFORGE HCT | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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EXFORGE HCT
South Africa

Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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pharmacompass-1-m-2026-01-12

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Cosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.

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pharmacompass-2-m-2025-11-03

EXFORGE HCT

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

187 API Suppliers, 42 USDMF, 45 CEP/COS, 27 JDMF, 35 EU WC, 87 KDMF, 26 NDC API, 60 Listed Suppliers, $ API Reference Price

187 API Suppliers
42 USDMF
45 CEP/COS
27 JDMF
35 EU WC
87 KDMF
26 NDC API
60 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

19 Drugs in Development

19 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1709 FDF Dossiers, 470 FDA Orange Book, 898 Europe, 135 Canada, 67 South Africa, 139 Listed Dossiers

1709 FDF Dossiers
470 FDA Orange Book
898 Europe
135 Canada
67 South Africa
139 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 2.5MG BASE, TABLET;ORAL - EQ 5MG BASE, CAPSULE;ORAL - EQ 10MG BASE;20MG, CAPSULE;ORAL - EQ 10MG BASE;40MG, CAPSULE;ORAL - EQ 2.5MG BASE;10MG, CAPSULE;ORAL - EQ 5MG BASE;10MG, CAPSULE;ORAL - EQ 5MG BASE;20MG, CAPSULE;ORAL - EQ 5MG BASE;40MG, TABLET;ORAL - EQ 10MG BASE;14MG, TABLET;ORAL - EQ 2.5MG BASE;3.5MG, TABLET;ORAL - EQ 5MG BASE;7MG, TABLET;ORAL - EQ 10MG BASE;200MG, TABLET;ORAL - EQ 2.5MG BASE;200MG, TABLET;ORAL - EQ 5MG BASE;200MG, TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE, TABLET;ORAL - EQ 10MG BASE;160MG, TABLET;ORAL - EQ 10MG BASE;320MG, TABLET;ORAL - EQ 5MG BASE;160MG, TABLET;ORAL - EQ 5MG BASE;320MG, TABLET;ORAL - EQ 10MG BASE;20MG, TABLET;ORAL - EQ 10MG BASE;40MG, TABLET;ORAL - EQ 5MG BASE;20MG, TABLET;ORAL - EQ 5MG BASE;40MG, TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;320MG, TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 5MG BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 10MG BASE
TABLET;ORAL - EQ 2.5MG BASE
TABLET;ORAL - EQ 5MG BASE
CAPSULE;ORAL - EQ 10MG BASE;20MG
CAPSULE;ORAL - EQ 10MG BASE;40MG
CAPSULE;ORAL - EQ 2.5MG BASE;10MG
CAPSULE;ORAL - EQ 5MG BASE;10MG
CAPSULE;ORAL - EQ 5MG BASE;20MG
CAPSULE;ORAL - EQ 5MG BASE;40MG
TABLET;ORAL - EQ 10MG BASE;14MG
TABLET;ORAL - EQ 2.5MG BASE;3.5MG
TABLET;ORAL - EQ 5MG BASE;7MG
TABLET;ORAL - EQ 10MG BASE;200MG
TABLET;ORAL - EQ 2.5MG BASE;200MG
TABLET;ORAL - EQ 5MG BASE;200MG
TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE
TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE
TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE
TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE
TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE
TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE
TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE
TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE
TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE
TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE
TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE
TABLET;ORAL - EQ 10MG BASE;160MG
TABLET;ORAL - EQ 10MG BASE;320MG
TABLET;ORAL - EQ 5MG BASE;160MG
TABLET;ORAL - EQ 5MG BASE;320MG
TABLET;ORAL - EQ 10MG BASE;20MG
TABLET;ORAL - EQ 10MG BASE;40MG
TABLET;ORAL - EQ 5MG BASE;20MG
TABLET;ORAL - EQ 5MG BASE;40MG
TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG
TABLET;ORAL - EQ 10MG BASE;25MG;160MG
TABLET;ORAL - EQ 10MG BASE;25MG;320MG
TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG
TABLET;ORAL - EQ 5MG BASE;25MG;160MG
TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 3 Rochem International Inc, 22 SPI Pharma, 1 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 5 Kirsch Pharma, 1 Panvo Organics, 4 ACG Worldwide, 5 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Ashland, 1 Avesta Pharma, 35 BASF, 1 CD Formulation, 3 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 4 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

82 Fillers, Diluents & Binders, 52 Coating Systems & Additives, 49 Direct Compression, 48 Disintegrants & Superdisintegrants, 37 Granulation, 37 Solubilizers, 37 Thickeners and Stabilizers, 31 Lubricants & Glidants, 29 Controlled & Modified Release, 27 Topical, 25 Parenteral, 23 Chewable & Orodispersible Aids, 23 Film Formers & Plasticizers, 20 Taste Masking, 15 Co-Processed Excipients, 12 Emulsifying Agents, 10 Surfactant & Foaming Agents, 10 API Stability Enhancers, 9 Empty Capsules, 8 Rheology Modifiers, 4 Vegetarian Capsules, 2 Coloring Agents

82 Fillers, Diluents & Binders
52 Coating Systems & Additives
49 Direct Compression
48 Disintegrants & Superdisintegrants
37 Granulation
37 Solubilizers
37 Thickeners and Stabilizers
31 Lubricants & Glidants
29 Controlled & Modified Release
27 Topical
25 Parenteral
23 Chewable & Orodispersible Aids
23 Film Formers & Plasticizers
20 Taste Masking
15 Co-Processed Excipients
12 Emulsifying Agents
10 Surfactant & Foaming Agents
10 API Stability Enhancers
9 Empty Capsules
8 Rheology Modifiers
4 Vegetarian Capsules
2 Coloring Agents

DIGITAL CONTENT

44 News #PharmaBuzz

44 News #PharmaBuzz

GLOBAL SALES INFORMATION

49 US Medicaid Prescriptions, 36 Regulatory FDF Prices

49 US Medicaid Prescriptions
36 Regulatory FDF Prices

MARKET PLACE

43 APIs, 7 FDF Dossiers

43 APIs
7 FDF Dossiers

PATENTS & EXCLUSIVITIES

28 US Patents, 195 Health Canada Patents

28 US Patents
195 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 EDQM, 3 USP, 7 JP, 1 Others

5 EDQM
3 USP
7 JP
1 Others

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

Filters

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Filters

FILTER :

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67 All

01 2Sanofi Aventis South Africa (Pty) Ltd

02 4Accord Healthcare (Pty) Ltd

03 2Aurogen South Africa (Pty) Ltd

04 4Austell Pharmaceuticals (Pty) Ltd

05 1Dezzo Trading 392 (Pty) Limited T/A Indo Pharma

06 2Hetero Drugs South Africa (Pty) Ltd

07 4LHC Pharmaceuticals (Pty) Ltd

08 2Novagen Pharma (Pty) Ltd

09 9Novartis South Africa (Pty) Ltd

10 4Ranbaxy Pharmaceuticals (Pty) Ltd

11 2SMART PHARMACEUTICALS (PTY) LTD

12 17Servier Laboratories S.A. (Pty) Ltd

13 4Unichem SA (Pty) Ltd

14 2Unimed Healthcare (Pty) Ltd

15 8Viatris South Africa (Pty) Ltd

filter Active Ingredients Reset all filters

67 All

01 2AMLODIPINE BESILATE

02 2Amlodipine Besilate

03 4Amlodipine besilate

04 10Amlodipine Besilate

05 1Amlodipine Besilate 10Mg

06 1Amlodipine Besilate 5Mg

07 7Amlodipine Besilate equivalent to Amlodipine

08 12Amlodipine Besylate

09 4Amlodipine Besylate equivalent to Amlodipine

10 6Amlodipine besilate

11 10Amlodipine besylate

12 8Amlodopine Besilate Equivalent to Amlodipine

filter Dosage Form Reset all filters

67 All

01 17FCT

02 42TAB

03 7Tab

04 1Tabs

filter Brand Name Reset all filters

67 All

01 1Amlessa 4 mg/ 10 mg

02 1Amlessa 4 mg/ 5 mg

03 1Amlessa 8 mg/ 10 mg

04 1Amlessa 8 mg/ 5 mg

05 1Amlodipine 10 Kiara

06 1Amlodipine 10 Unimed

07 1Amlodipine 5 Kiara

08 1Amlodipine 5 Unimed

09 1Amlodipine Hetero 10

10 1Amlodipine Hetero 5

11 1Amlodipine Unicorn 10

12 1Amlodipine Unicorn 5

13 1Amlodipine ascendis 5

14 2Amlodipine-Winthrop

15 1Amtas 10

16 1Amtas 5

17 1Aprate 10 mg

18 1Aprate 5 mg

19 1Austell-Amlodipine 10mg

20 1Austell-Amlodipine 5mg

21 2Calbloc

22 1Co Exforge 10 Mg/160 Mg/12.5 Mg

23 1Co Exforge 10 Mg/160 Mg/25 Mg

24 1Co Exforge 10 mg/320 mg/25 mg

25 1Co Exforge 5 Mg/160 Mg/12.5 Mg

26 1Co Exforge 5 Mg/160 Mg/25 Mg

27 1Coveram 5/10

28 1Exforge

29 1Exforge 10 mg/320 mg

30 1Exforge 10Mg/160Mg Tablets

31 1Exforge 5 mg/320 mg

32 1GEMVALAZ 10/160

33 1GEMVALAZ 5/160

34 1Keysal 10 mg

35 1Keysal 5 mg

36 1MIXANVAL 10/10

37 1MIXANVAL 10/5

38 1MIXANVAL 5/10

39 1MIXANVAL 5/5

40 1Mizart Plus 40/10

41 1Mizart Plus 40/5

42 1Mizart Plus 80/10

43 1Mizart Plus 80/5

44 1NATRIXAM 1.5/10 mg

45 1NATRIXAM 1.5/5 mg

46 1Pendine 10

47 1Pendine 5

48 1Reaptan 5/10

49 1Retissor 10/10

50 1Retissor 10/5

51 1Retissor 5/10

52 1Retissor 5/5

53 1Tecarini 40/10

54 1Tecarini 40/5

55 1Tecarini 80/10

56 1Tecarini 80/5

57 1Triveram 10/5/5 mg

58 1Triveram 20/10/10 mg

59 1Triveram 20/10/5 mg

60 1Triveram 20/5/5 mg

61 1Triveram 40/10/10 mg

62 1Valvasc 10/160

63 1Valvasc 5/160

64 1Vasloc 10 mg

65 1Vasloc 5 mg

List of Suppliers

Product Main Page

01

Sanofi Aventis South Africa (Pty) Ltd

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

Contact Supplier

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Amlodipine Besilate

Brand Name : Amlodipine-Winthrop

Dosage Form : TAB

Dosage Strength : 5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Sanofi Company Banner

Portfolio PDF

Product Web Link

Digital Content

02

Sanofi Aventis South Africa (Pty) Ltd

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

Contact Supplier

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Amlodipine Besilate

Brand Name : Amlodipine-Winthrop

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Sanofi Company Banner

Portfolio PDF

Product Web Link

Digital Content

03

Accord Healthcare (Pty) Ltd

SCOPE Summit

Not Confirmed

Accord Healthcare (Pty) Ltd

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Amlodipine Besilate

Brand Name : Amtas 5

Dosage Form : TAB

Dosage Strength : 5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Accord Healthcare (Pty) Ltd

SCOPE Summit

Not Confirmed

Accord Healthcare (Pty) Ltd

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Amlodipine Besilate

Brand Name : Amtas 10

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

Accord Healthcare (Pty) Ltd

SCOPE Summit

Not Confirmed

Accord Healthcare (Pty) Ltd

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Amlodipine besilate

Brand Name : Amlodipine Unicorn 5

Dosage Form : TAB

Dosage Strength : 5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Accord Healthcare (Pty) Ltd

SCOPE Summit

Not Confirmed

Accord Healthcare (Pty) Ltd

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Amlodipine besilate

Brand Name : Amlodipine Unicorn 10

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

07

Austell Pharmaceuticals (Pty) Ltd

SCOPE Summit

Not Confirmed

Austell Pharmaceuticals (Pty) Ltd

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Post an Enquiry

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Amlodipine Besylate

Brand Name : Valvasc 5/160

Dosage Form : FCT

Dosage Strength : 5mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Austell Pharmaceuticals (Pty) Ltd

SCOPE Summit

Not Confirmed

Austell Pharmaceuticals (Pty) Ltd

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Amlodipine Besylate

Brand Name : Valvasc 10/160

Dosage Form : FCT

Dosage Strength : 10mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Aurogen South Africa (Pty) Ltd

Country

SCOPE Summit

Not Confirmed

Aurogen South Africa (Pty) Ltd

Country

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Post an Enquiry

Country

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Amlodipine Besilate

Brand Name : Aprate 5 mg

Dosage Form : TAB

Dosage Strength : 5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

10

Aurogen South Africa (Pty) Ltd

Country

SCOPE Summit

Not Confirmed

Aurogen South Africa (Pty) Ltd

Country

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Country

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Amlodipine Besilate

Brand Name : Aprate 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

Virtual Booth

Digital Content

Website

Corporate PDF

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.