Metformin Hydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Metformin Hydrochloride
South Africa

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Metformin Hydrochloride

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

179 API Suppliers, 57 USDMF, 43 CEP/COS, 13 JDMF, 31 EU WC, 99 KDMF, 39 NDC API, 46 Listed Suppliers, $ API Reference Price

179 API Suppliers
57 USDMF
43 CEP/COS
13 JDMF
31 EU WC
99 KDMF
39 NDC API
46 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

33 Drugs in Development

33 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1938 FDF Dossiers, 427 FDA Orange Book, 534 Europe, 134 Canada, 136 Australia, 140 South Africa, 567 Listed Dossiers

1938 FDF Dossiers
427 FDA Orange Book
534 Europe
134 Canada
136 Australia
140 South Africa
567 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;1GM, TABLET;ORAL - 2.5MG;500MG, TABLET;ORAL - 2.5MG;850MG, TABLET;ORAL - EQ 12.5MG BASE;1GM, TABLET;ORAL - EQ 12.5MG BASE;500MG, TABLET;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 150MG;1GM, TABLET, EXTENDED RELEASE;ORAL - 150MG;500MG, TABLET, EXTENDED RELEASE;ORAL - 50MG;1GM, TABLET, EXTENDED RELEASE;ORAL - 50MG;500MG, TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION, EXTENDED RELEASE;ORAL - 500MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 500MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 1GM, TABLET, EXTENDED RELEASE;ORAL - 500MG, TABLET;ORAL - 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 850MG;EQ 15MG BASE, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 15MG BASE, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 30MG BASE, TABLET;ORAL - 1GM;EQ 50MG BASE, TABLET;ORAL - 500MG;EQ 50MG BASE, TABLET;ORAL - 500MG;1MG, TABLET;ORAL - 500MG;2MG

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 2.5MG;1GM
TABLET;ORAL - 2.5MG;500MG
TABLET;ORAL - 2.5MG;850MG
TABLET;ORAL - EQ 12.5MG BASE;1GM
TABLET;ORAL - EQ 12.5MG BASE;500MG
TABLET;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 150MG;1GM
TABLET, EXTENDED RELEASE;ORAL - 150MG;500MG
TABLET, EXTENDED RELEASE;ORAL - 50MG;1GM
TABLET, EXTENDED RELEASE;ORAL - 50MG;500MG
TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FOR SUSPENSION, EXTENDED RELEASE;ORAL - 500MG/5ML
TABLET, EXTENDED RELEASE;ORAL - 1GM
TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;ORAL - 500MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 1GM
TABLET, EXTENDED RELEASE;ORAL - 500MG
TABLET;ORAL - 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 850MG;EQ 15MG BASE
TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 15MG BASE
TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 30MG BASE
TABLET;ORAL - 1GM;EQ 50MG BASE
TABLET;ORAL - 500MG;EQ 50MG BASE
TABLET;ORAL - 500MG;1MG
TABLET;ORAL - 500MG;2MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 2 Minakem, 8 Evonik, 7 Rochem International Inc, 23 SPI Pharma, 19 DKSH, 2 Pharm-RX Chemical, 9 Faran Shimi Pharmaceutical, 13 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 12 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 1 ACG Worldwide, 12 Actylis, 3 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Ashland, 1 Avesta Pharma, 38 BASF, 1 Bioplus Life Sciences, 2 Clariant, 27 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 39 Kerry, 5 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 5 Lubrizol Life Science Health, 22 Microlex e.U, 2 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 11 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 35 Roquette, 14 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 3 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

123 Fillers, Diluents & Binders, 65 Coating Systems & Additives, 56 Controlled & Modified Release, 53 Thickeners and Stabilizers, 52 Disintegrants & Superdisintegrants, 51 Direct Compression, 48 Solubilizers, 42 Taste Masking, 41 Granulation, 40 Film Formers & Plasticizers, 39 Topical, 30 Parenteral, 30 Lubricants & Glidants, 24 Co-Processed Excipients, 23 Chewable & Orodispersible Aids, 14 Emulsifying Agents, 14 Rheology Modifiers, 10 API Stability Enhancers, 6 Surfactant & Foaming Agents, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

123 Fillers, Diluents & Binders
65 Coating Systems & Additives
56 Controlled & Modified Release
53 Thickeners and Stabilizers
52 Disintegrants & Superdisintegrants
51 Direct Compression
48 Solubilizers
42 Taste Masking
41 Granulation
40 Film Formers & Plasticizers
39 Topical
30 Parenteral
30 Lubricants & Glidants
24 Co-Processed Excipients
23 Chewable & Orodispersible Aids
14 Emulsifying Agents
14 Rheology Modifiers
10 API Stability Enhancers
6 Surfactant & Foaming Agents
5 Empty Capsules
5 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 372 News #PharmaBuzz

1 Data Compilation #PharmaFlow
372 News #PharmaBuzz

GLOBAL SALES INFORMATION

87 US Medicaid Prescriptions, 494 Regulatory FDF Prices, 25 Annual Reports

87 US Medicaid Prescriptions
494 Regulatory FDF Prices
25 Annual Reports

MARKET PLACE

91 APIs, 51 FDF Dossiers

91 APIs
51 FDF Dossiers

PATENTS & EXCLUSIVITIES

610 US Patents, 54 US Exclusivities, 17 Health Canada Patents

610 US Patents
54 US Exclusivities
17 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 7 Others

3 EDQM
1 USP
7 Others

ANALYTICAL

2 BioAnalytical Methods, 1 Analytical Methods

2 BioAnalytical Methods
1 Analytical Methods

$ API Ref.Price (USD/KG) : 4 Xls

Filters

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Filters

FILTER :

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140 All

01 1Sanofi Aventis South Africa (Pty) Ltd

02 2Pharmacare Limited, Woodmead

03 3Accord Healthcare (Pty) Ltd

04 3Adcock Ingram Limited

05 2Arrow Pharma South Africa (Pty) Ltd

06 8Ascend Laboratories (Pty) Ltd

07 2Astrazeneca Pharmaceuticals (Pty) Ltd- Bryanston

08 3Aurogen South Africa (Pty) Ltd

09 4Austell Laboratories (Pty) Ltd

10 3Biotech Laboratories (Pty) Ltd

11 2Camox Pharmaceuticals (Pty) Ltd

12 5Cipla Medpro (Pty) Ltd

13 4Dezzo Trading 392 (Pty) Limited T/A Indo Pharma

14 2Dr Reddy's Laboratories (Pty) Ltd

15 6Gulf Drug Company (Pty) Ltd

16 6Ingelheim Pharmaceuticals (Pty) Ltd

17 2Kiara Health (PTY) LTD

18 3MSD (Pty) Ltd

19 5Macleods Pharmaceuticals SA (Pty) Ltd

20 2Medivision (Pty) Ltd

21 19Merck (Pty) Ltd

22 12Mylan (Pty) Ltd

23 3Novagen Pharma (Pty) Ltd

24 8Novartis South Africa (Pty) Ltd

25 3Pharmacorp (Pty) Ltd

26 7Ranbaxy Pharmaceuticals (Pty) Ltd

27 2Sandoz SA (Pty) Ltd

28 5Strides Pharma SA (Pty) Ltd

29 1Teva Pharmaceuticals (Pty) Ltd

30 6Trinity Pharma (Pty) Ltd

31 2Unicorn Pharmaceuticals (Pty) Ltd

32 4Unimed Healthcare (Pty) Ltd

filter Active Ingredients Reset all filters

140 All

01 7METFORMIN HYDROCHLORIDE

02 26Metformin

03 1Metformin 850 mg

04 7Metformin HCl

05 9Metformin Hcl

06 61Metformin Hydrochloride

07 6Metformin Hydrochloride 500 mg

08 3Metformin Hydrochloride 850 mg

09 15Metformin hydrochloride

10 3metformin

11 2metformin hydrochloride

filter Dosage Form Reset all filters

140 All

01 2ERT

02 44FCT

03 94TAB

filter Brand Name Reset all filters

140 All

01 1Accord Metformin 500

02 1Accord Metformin 850

03 1Amaryl Combi 2/500

04 1Arrow Metformin 500

05 1Arrow Metformin 850

06 2Austell Metformin 500 mg Tablets

07 2Austell Metformin 850 mg Tablets

08 1Cadbower XR 1000

09 3Cadbower XR 500

10 1Carbuce 1000

11 1Carbuce 500

12 1Carbuce 850

13 1Carbuce XR 1000

14 1Carbuce XR 500

15 1Diabetmin Retard 850

16 1Diaformin 500 mg Tablets

17 1Diaformin Forte 850 mg Tablets

18 2Diamin-500

19 2Diamin-850

20 1Diaphage 1000

21 1Diaphage 500

22 1Diaphage 850

23 3Forminal 500

24 2Forminal 850

25 1Fortese 1g

26 1Fortese XR 500

27 2Galvus Met 50 Mg/1000Mg

28 2Galvus Met 50 Mg/850 Mg

29 1Gluconorm 500

30 1Gluconorm 850

31 5Glucophage

32 1Glucophage 1000 mg

33 2Glucophage XR 1000 mg

34 2Glucophage XR 750 mg

35 1Glucophage Xr

36 2Glucophage Xr 500 mg

37 1Glucotrin XR 1000

38 1Glucotrin XR 500

39 2Glucovance 250Mg/1.25Mg

40 2Glucovance 500Mg/2.5Mg

41 2Glucovance 500Mg/5Mg

42 2Jalramet 50/1000mg

43 2Jalramet 50/850mg

44 1Janumet 50/1000 mg

45 1Janumet 50/500 mg

46 1Janumet 50/850 mg

47 1METFORMIN TEVA ER 1 000MG

48 1METPLITIN CO 50/1 000

49 1METPLITIN CO 50/850

50 1METSITAG 50/1 000

51 1METSITAG 50/500

52 1Macloglymin 1000 mg

53 1Macloglymin 500 mg

54 1Macloglymin 850 mg

55 1Mengen 1000 mg

56 1Mengen 500 mg

57 1Mengen 850 mg

58 1Metchek 500

59 1Metchek 850

60 1Metforal 500

61 1Metforal 850

62 1Metformin 1000 XR Adco

63 1Metformin 1000 mg PharmC

64 1Metformin 1g Alkem

65 2Metformin 500 Biotech

66 1Metformin 500 mg PharmC

67 1Metformin 850 Biotech

68 1Metformin 850 mg PharmC

69 2Metformin Alkem 500 mg

70 3Metformin Alkem 850 mg

71 2Metformin Ascendis 500

72 2Metformin Ascendis 850

73 1Metformin HCl 500 FC Kiara

74 1Metformin HCl 850 FC Kiara

75 1Metformin XR 500mg Accord

76 1Metored 1000

77 1Metored 500

78 1Metored 850

79 1Metphage 500 Mg

80 1Metphage 850 Mg

81 1Mylan Metformin 1 000 mg

82 8Mylan Metformin 500

83 3Mylan Metformin 850

84 1Romidab 1000 mg Tablets

85 1Romidab 500 mg Tablets

86 1Romidab 850 mg Tablets

87 1Sandoz Metformin Hcl 500

88 1Sandoz Metformin Hcl 850

89 1Synglutra 10/1000

90 1Synglutra 5/1000

91 1Synjardy 12,5/1000 mg

92 1Synjardy 12,5/500 mg

93 1Synjardy 12,5/850 mg

94 1Synjardy 5/1000 mg

95 1Synjardy 5/500 mg

96 1Synjardy 5/850 mg

97 2VILEPTIN CO 50/1 000

98 2VILEPTIN CO 50/850

99 2Xigduo XR

Granules Metformin

List of Suppliers

Product Main Page

01

Sanofi Aventis South Africa (Pty) Ltd

ChemOutsourcing

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

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Metformin Hydrochloride

Brand Name : Amaryl Combi 2/500

Dosage Form : TAB

Dosage Strength : 500mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Sanofi Company Banner

Portfolio PDF

Product Web Link

Digital Content

02

Pharmacare Limited, Woodmead

APGA Annual Conference

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Metformin Hydrochloride

Brand Name : Metphage 500 Mg

Dosage Form : TAB

Dosage Strength : 500mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

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Product Web Link

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Corporate PDF

03

Pharmacare Limited, Woodmead

APGA Annual Conference

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Metformin Hydrochloride

Brand Name : Metphage 850 Mg

Dosage Form : TAB

Dosage Strength : 850mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

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04

Accord Healthcare (Pty) Ltd

APGA Annual Conference

Not Confirmed

Accord Healthcare (Pty) Ltd

APGA Annual Conference

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Metformin Hydrochloride

Brand Name : Accord Metformin 850

Dosage Form : TAB

Dosage Strength : 850mg

Packaging : 60X1mg

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

APGA Annual Conference

Not Confirmed

Accord Healthcare (Pty) Ltd

APGA Annual Conference

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Metformin Hydrochloride

Brand Name : Accord Metformin 500

Dosage Form : TAB

Dosage Strength : 500mg

Packaging : 100X1mg

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

APGA Annual Conference

Not Confirmed

Accord Healthcare (Pty) Ltd

APGA Annual Conference

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Metformin HCl

Brand Name : Metformin XR 500mg Accord

Dosage Form : TAB

Dosage Strength : 500mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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07

Adcock Ingram Limited

APGA Annual Conference

Not Confirmed

Adcock Ingram Limited

APGA Annual Conference

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Regulatory Info : Generic

Registration Country : South Africa

Metformin Hydrochloride

Brand Name : Metformin 1000 XR Adco

Dosage Form : TAB

Dosage Strength : 1000mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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08

Adcock Ingram Limited

APGA Annual Conference

Not Confirmed

Adcock Ingram Limited

APGA Annual Conference

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Regulatory Info : Generic

Registration Country : South Africa

Metformin Hydrochloride

Brand Name : Metforal 850

Dosage Form : TAB

Dosage Strength : 850mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

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Corporate PDF

09

Adcock Ingram Limited

APGA Annual Conference

Not Confirmed

Adcock Ingram Limited

APGA Annual Conference

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Metformin Hydrochloride

Brand Name : Metforal 500

Dosage Form : TAB

Dosage Strength : 500mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

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10

Arrow Pharma South Africa (Pty) Ltd

APGA Annual Conference

Not Confirmed

Arrow Pharma South Africa (Pty) Ltd

APGA Annual Conference

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Metformin hydrochloride

Brand Name : Arrow Metformin 500

Dosage Form : TAB

Dosage Strength : 500mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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