Clavulanic Acid | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Clavulanic Acid
South Africa

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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Clavulanic Acid

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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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

FINISHED DOSAGE FORMULATIONS

641 FDF Dossiers, 73 FDA Orange Book, 337 Europe, 105 South Africa, 126 Listed Dossiers

641 FDF Dossiers
73 FDA Orange Book
337 Europe
105 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TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML, FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML, TABLET;ORAL -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EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 14 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
14 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

309 Finished Drug Prices, 5 Annual Reports

309 Finished Drug Prices
5 Annual Reports

MARKET PLACE

49 APIs, 9 FDF Dossiers

49 APIs
9 FDF Dossiers

REF. STANDARDS & IMPURITIES

4 EDQM, 4 Others

4 EDQM
4 Others

$ API Ref.Price (USD/KG) : 79 Xls

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105 All

01 4Pharmacare Limited, Woodmead

02 4APOTHECON LABS cc

03 2Activo Health (Pty) Ltd

04 3Actor Pharma (Pty) Ltd

05 6Adcock Ingram Limited

06 1Astellas Pharma (Pty) Ltd

07 2Aurobindo Pharma (Pty) Ltd

08 3Aurogen South Africa (Pty) Ltd

09 2Austell Laboratories (Pty) Ltd

10 1Austell Pharmaceuticals (Pty) Ltd

11 5Biotech Laboratories (Pty) Ltd

12 10Camox Pharmaceuticals (Pty) Ltd

13 5Cipla Medpro (Pty) Ltd

14 11Glaxosmithkline South Africa (Pty) Ltd - Cape Town

15 2Gulf Drug Company (Pty) Ltd

16 1Mylan (Pty) Ltd

17 3Ranbaxy Pharmaceuticals (Pty) Ltd

18 2Ranbaxy S.A (Pty) Ltd

19 22Sandoz SA (Pty) Ltd

20 4Sandoz SA Pty Ltd

21 3Trinity Pharma (Pty) Ltd

22 2Unichem SA (Pty) Ltd

23 3Unicorn Pharmaceuticals (Pty) Ltd

24 4Xixia Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

105 All

01 14Clavulanic Acid

02 85Clavulanic acid

03 6Potassium Clavulanate

filter Dosage Form Reset all filters

105 All

01 1DSP

02 6FCT

03 1INH

04 13INJ

05 1LIQ

06 1PWD

07 2SOL

08 32SUS

09 2SYR

10 46TAB

filter Brand Name Reset all filters

105 All

01 2APOCLAV 0,6 G

02 2APOCLAV 1,2 G

03 1Actimentin 1000

04 2Actimentin 600 BD

05 1Adco Amoclav 625

06 1Adco Amoclav Forte Suspension

07 1Adco Amoxyclav BD

08 1Adco-Amoclav 375

09 1Adco-Amoclav BD

10 1Adco-amoclav s

11 1Amoclan

12 1Amoclan BID Tablets

13 1Amoclan Forte

14 1Amoclan S

15 1Amoclan SF

16 1Apex Clavutin 375 mg Tablets

17 1Apex Clavutin 625 mg Tablets

18 1Apex Clavutin SF

19 1Augmaxcil Injection

20 1Augspec 1g

21 1Auro Amoxiclav 1000 mg

22 1Auro Amoxiclav 375 mg

23 1Auro Amoxiclav 625 mg

24 1Auro-Amoxiclav 125-31.25 mg/5ml

25 1Auro-Amoxiclav 250-62.5 mg/5ml

26 1Austell Co-Amoxiclav BD S

27 2Austell Co-Amoxiclav BD SF

28 2Austell Co-Amoxiclav ES 600

29 1Austell-Co-Amoxyclav 625 mg

30 1Austell-Co-amoxiclav 375 mg

31 1BINDOCLAV 1000 mg

32 1BINDOCLAV 375 mg

33 1BINDOCLAV 625 mg

34 1Betaclav 1000

35 1Betaclav 375

36 1Betaclav 625

37 1Bio-Amoksiklav 1000

38 1Bio-Amoksiklav 375

39 1Bio-Amoksiklav 625

40 1Bio-Amoksiklav S

41 1Bio-Amoksiklav SF

42 2Camox Co-Amoxiclav ES 600

43 1Clamentin 1 000 mg

44 2Clamentin 375

45 1Clamentin Iv

46 1Clamentin S

47 1Clamentin SF

48 1Clavumox S

49 1Clavumox Sf

50 1Co Maug 1g

51 1Co-Amoxiclav 1000 SR Sandoz

52 1Co-Amoxyclav BD Austell

53 2Co-Amoxyclav ES Sandoz

54 1Curam BD Suspension

55 1Curam 1000

56 1Curam 625

57 1Curam BD Suspension

58 2Curam ES

59 1Forcid Solutab 875/125

60 1Gulf Amoxy Co 1000/200

61 1Gulf Amoxy Co 500/100

62 1KLAVIMAXCIL 1000 DISP TABLET

63 1Kivexa

64 1Myclav 375

65 1Myclav 625

66 1Naramig

67 1RANCLAV 625

68 1Ranclav 1g

69 1Ranclav 375 Tablets

70 1Ranclav 625 Tablets

71 1Ranclav forte SUSP

72 2Retrovir

73 1Sandoz Co-Amoxyclav

74 1Sandoz Co-Amoxyclav 1.2G (20Ml)

75 1Sandoz Co-Amoxyclav 1.2G 20Ml

76 1Sandoz Co-Amoxyclav 0.6G 20Ml

77 1Sandoz Co-Amoxyclav 0.6G/10Ml

78 2Sandoz Co-Amoxyclav 1000

79 2Sandoz Co-Amoxyclav 375

80 3Sandoz Co-Amoxyclav 625

81 1Sandoz Co-Amoxyclav BD Suspension

82 1Sandoz Co-Amoxyclav S

83 1Sandoz Co-Amoxyclav Sf

84 1Sandoz Co-amoxyclav BD Suspension

85 2Stiemycin

86 3Trizivar

87 1Ventolin CFC-Free 200

88 1Ventolin Syrup

List of Suppliers

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01

Pharmacare Limited, Woodmead

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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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Pharmacare Limited, Woodmead

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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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Pharmacare Limited, Woodmead

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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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Pharmacare Limited, Woodmead

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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

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Activo Health (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Clavulanic acid

Brand Name : Actimentin 600 BD

Dosage Form : SUS

Dosage Strength : 42.9mg/5ml

Packaging : 50X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Activo Health (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Clavulanic acid

Brand Name : Actimentin 600 BD

Dosage Form : SUS

Dosage Strength : 42.9mg/5ml

Packaging : 100X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Actor Pharma (Pty) Ltd

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Actor Pharma (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Potassium Clavulanate

Brand Name : BINDOCLAV 375 mg

Dosage Form : TAB

Dosage Strength : 125mg

Packaging : 15X1mg

Approval Date :

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Regulatory Info : Generic

Registration Country : South Africa

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Actor Pharma (Pty) Ltd

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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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Actor Pharma (Pty) Ltd

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Actor Pharma (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Potassium Clavulanate

Brand Name : BINDOCLAV 1000 mg

Dosage Form : TAB

Dosage Strength : 125mg

Packaging : 10X1mg

Approval Date :

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Regulatory Info : Generic

Registration Country : South Africa

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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

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Regulatory Info : Generic

Registration Country : South Africa

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