Potassium Clavulanate | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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

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Potassium Clavulanate

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

44 API Suppliers, 25 USDMF, 34 CEP/COS, 61 KDMF, 14 NDC API, 11 Listed Suppliers, $ API Reference Price

44 API Suppliers
25 USDMF
34 CEP/COS
61 KDMF
14 NDC API
11 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

632 FDF Dossiers, 73 FDA Orange Book, 337 Europe, 96 South Africa, 126 Listed Dossiers

632 FDF Dossiers
73 FDA Orange Book
337 Europe
96 South Africa
126 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML, FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML, TABLET;ORAL - 875MG;EQ 125MG BASE, FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML, FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML, FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML
FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML
TABLET;ORAL - 875MG;EQ 125MG BASE
FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML
FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML
FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML
TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Evonik, 5 Rochem International Inc, 13 SPI Pharma, 2 Seqens, 14 DKSH, 1 Pharm-RX Chemical, 5 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 31 BASF, 2 Clariant, 11 Corel Pharma Chem, 4 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 17 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 16 Roquette, 12 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

64 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 38 Disintegrants & Superdisintegrants, 35 Direct Compression, 35 Thickeners and Stabilizers, 32 Controlled & Modified Release, 31 Solubilizers, 27 Granulation, 22 Topical, 21 Taste Masking, 21 Film Formers & Plasticizers, 18 Parenteral, 18 Lubricants & Glidants, 15 Chewable & Orodispersible Aids, 14 Co-Processed Excipients, 10 Rheology Modifiers, 9 Emulsifying Agents, 7 API Stability Enhancers, 6 Surfactant & Foaming Agents, 5 Empty Capsules, 4 Coloring Agents, 4 Vegetarian Capsules

64 Fillers, Diluents & Binders
51 Coating Systems & Additives
38 Disintegrants & Superdisintegrants
35 Direct Compression
35 Thickeners and Stabilizers
32 Controlled & Modified Release
31 Solubilizers
27 Granulation
22 Topical
21 Taste Masking
21 Film Formers & Plasticizers
18 Parenteral
18 Lubricants & Glidants
15 Chewable & Orodispersible Aids
14 Co-Processed Excipients
10 Rheology Modifiers
9 Emulsifying Agents
7 API Stability Enhancers
6 Surfactant & Foaming Agents
5 Empty Capsules
4 Coloring Agents
4 Vegetarian Capsules

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 16 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
16 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

309 Finished Drug Prices, 5 Annual Reports

309 Finished Drug Prices
5 Annual Reports

MARKET PLACE

50 APIs, 9 FDF Dossiers

50 APIs
9 FDF Dossiers

REF. STANDARDS & IMPURITIES

4 EDQM, 4 Others

4 EDQM
4 Others

$ API Ref.Price (USD/KG) : 102 Xls

Filters

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96 All

01 4Pharmacare Limited, Woodmead

02 3APOTHECON LABS cc

03 3Actor Pharma (Pty) Ltd

04 6Adcock Ingram Limited

05 1Astellas Pharma (Pty) Ltd

06 5Aurobindo Pharma (Pty) Ltd

07 2Austell Laboratories (Pty) Ltd

08 1Austell Pharmaceuticals (Pty) Ltd

09 5Biotech Laboratories (Pty) Ltd

10 10Camox Pharmaceuticals (Pty) Ltd

11 5Cipla Medpro (Pty) Ltd

12 11Glaxosmithkline South Africa (Pty) Ltd - Cape Town

13 2Gulf Drug Company (Pty) Ltd

14 1Mylan (Pty) Ltd

15 6Ranbaxy Pharmaceuticals (Pty) Ltd

16 2Ranbaxy S.A (Pty) Ltd

17 17Sandoz SA (Pty) Ltd

18 4Sandoz SA Pty Ltd

19 2Trinity Pharma (Pty) Ltd

20 2Unichem SA (Pty) Ltd

21 4Xixia Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

96 All

01 12Clavulanic Acid

02 78Clavulanic acid

03 6Potassium Clavulanate

filter Dosage Form Reset all filters

96 All

01 1DSP

02 6FCT

03 1INH

04 12INJ

05 1LIQ

06 1PWD

07 2SOL

08 25SUS

09 1SUSP

10 2SYR

11 44TAB

filter Brand Name Reset all filters

96 All

01 2APOCLAV 0,6 G

02 1APOCLAV 1,2 G

03 1Actimentin 1000

04 1Adco Amoclav 625

05 1Adco Amoclav Forte Suspension

06 1Adco Amoxyclav BD

07 1Adco-Amoclav 375

08 1Adco-Amoclav Bd

09 1Adco-amoclav s

10 1Amoclan

11 1Amoclan BID Tablets

12 1Amoclan Forte

13 1Amoclan S

14 1Amoclan SF

15 1Apex Clavutin 375 mg Tablets

16 1Apex Clavutin 625 mg Tablets

17 1Apex Clavutin SF

18 1Augmaxcil Injection

19 1Augspec 1g

20 1Auro Amoxiclav 1000 mg

21 1Auro Amoxiclav 375 mg

22 1Auro Amoxiclav 625 mg

23 1Auro-Amoxiclav 125-31.25 mg/5ml

24 1Auro-Amoxiclav 250-62.5 mg/5ml

25 1Austell Co-Amoxiclav BD S

26 2Austell Co-Amoxiclav BD SF

27 2Austell Co-Amoxiclav ES 600

28 1Austell-Co-Amoxyclav 625 mg

29 1Austell-Co-amoxiclav 375 mg

30 1BINDOCLAV 1000 mg

31 1BINDOCLAV 375 mg

32 1BINDOCLAV 625 mg

33 1Betaclav 1000

34 1Betaclav 375

35 1Betaclav 625

36 1Bio-Amoksiklav 1000

37 1Bio-Amoksiklav 375

38 1Bio-Amoksiklav 625

39 1Bio-Amoksiklav S

40 1Bio-Amoksiklav SF

41 2Camox Co-Amoxiclav ES 600

42 1Clamentin 1 000 mg

43 2Clamentin 375

44 1Clamentin Iv

45 1Clamentin S

46 1Clamentin Sf

47 1Clavumox S

48 1Clavumox Sf

49 1Co-Amoxyclav BD Austell

50 1Curam BD Suspension

51 1Curam 1000

52 1Curam 625

53 1Curam BD Suspension

54 1Forcid Solutab 875/125

55 1Gulf Amoxy Co 1000/200

56 1Gulf Amoxy Co 500/100

57 1KLAVIMAXCIL 1000 DISP TABLET

58 1Kivexa

59 1Myclav 375

60 1Myclav 625

61 1Naramig

62 1RANCLAV 625

63 1Ranclav 1g

64 1Ranclav 375 Tablets

65 1Ranclav 625 Tablets

66 1Ranclav forte SUSP

67 2Retrovir

68 1Sandoz Co-Amoxyclav

69 1Sandoz Co-Amoxyclav 1.2G (20Ml)

70 1Sandoz Co-Amoxyclav 1.2G 20Ml

71 1Sandoz Co-Amoxyclav 0.6G 20Ml

72 1Sandoz Co-Amoxyclav 0.6G/10Ml

73 2Sandoz Co-Amoxyclav 1000

74 2Sandoz Co-Amoxyclav 375

75 3Sandoz Co-Amoxyclav 625

76 1Sandoz Co-Amoxyclav BD Suspension

77 1Sandoz Co-Amoxyclav S

78 1Sandoz Co-Amoxyclav Sf

79 1Sandoz Co-amoxyclav BD Suspension

80 2Stiemycin

81 3Trizivar

82 1Ventolin CFC-Free 200

83 1Ventolin Syrup

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Clavulanic acid

Brand Name : Augmaxcil Injection

Dosage Form : INJ

Dosage Strength : 200mg/20ml

Packaging : 20X1mg/20ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Pharmacare Limited, Woodmead

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Clavulanic acid

Brand Name : Clavumox S

Dosage Form : SUS

Dosage Strength : 31.25mg/5ml

Packaging : 100X1mg/ 5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Pharmacare Limited, Woodmead

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Clavulanic acid

Brand Name : Clavumox Sf

Dosage Form : SUS

Dosage Strength : 62.5mg/5ml

Packaging : 100X1mg/ 5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Pharmacare Limited, Woodmead

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Clavulanic acid

Brand Name : Clamentin Iv

Dosage Form : INJ

Dosage Strength : 200mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

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05

Actor Pharma (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Potassium Clavulanate

Brand Name : BINDOCLAV 375 mg

Dosage Form : TAB

Dosage Strength : 125mg

Packaging : 15X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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06

Actor Pharma (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Potassium Clavulanate

Brand Name : BINDOCLAV 625 mg

Dosage Form : TAB

Dosage Strength : 125mg

Packaging : 15X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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07

Actor Pharma (Pty) Ltd

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Actor Pharma (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Potassium Clavulanate

Brand Name : BINDOCLAV 1000 mg

Dosage Form : TAB

Dosage Strength : 125mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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08

Adcock Ingram Limited

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Adcock Ingram Limited

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Regulatory Info : Generic

Registration Country : South Africa

Clavulanic acid

Brand Name : Adco-Amoclav Bd

Dosage Form : TAB

Dosage Strength : 125mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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09

Adcock Ingram Limited

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Adcock Ingram Limited

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Regulatory Info : Generic

Registration Country : South Africa

Clavulanic Acid

Brand Name : Adco Amoxyclav BD

Dosage Form : TAB

Dosage Strength : 125mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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10

Adcock Ingram Limited

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Adcock Ingram Limited

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Regulatory Info : Generic

Registration Country : South Africa

Clavulanic acid

Brand Name : Adco-Amoclav 375

Dosage Form : TAB

Dosage Strength : 125mg

Packaging : 15X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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