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

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Metformin HCl
South Africa

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Metformin HCl

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

181 API Suppliers, 57 USDMF, 40 CEP/COS, 13 JDMF, 30 EU WC, 101 KDMF, 40 NDC API, 46 Listed Suppliers, $ API Reference Price

181 API Suppliers
57 USDMF
40 CEP/COS
13 JDMF
30 EU WC
101 KDMF
40 NDC API
46 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

669 Drugs in Development

669 Drugs in Development

FINISHED DOSAGE FORMULATIONS

2260 FDF Dossiers, 447 FDA Orange Book, 836 Europe, 140 Canada, 136 Australia, 150 South Africa, 551 Listed Dossiers

2260 FDF Dossiers
447 FDA Orange Book
836 Europe
140 Canada
136 Australia
150 South Africa
551 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TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;1GM, TABLET;ORAL - 2.5MG;500MG, TABLET;ORAL - 2.5MG;850MG, TABLET;ORAL - EQ 12.5MG BASE;1GM,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- EQ 12.5MG BASE;500MG, TABLET;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 150MG;1GM, TABLET, EXTENDED RELEASE;ORAL - 150MG;500MG, TABLET, EXTENDED RELEASE;ORAL -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 **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**, 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 **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**
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, 13 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 12 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 6 Kirsch Pharma, 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 CD Formulation, 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, 26 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

108 Fillers, Diluents & Binders, 63 Coating Systems & Additives, 57 Direct Compression, 54 Thickeners and Stabilizers, 52 Disintegrants & Superdisintegrants, 52 Controlled & Modified Release, 48 Solubilizers, 46 Granulation, 42 Taste Masking, 40 Film Formers & Plasticizers, 39 Topical, 32 Parenteral, 30 Lubricants & Glidants, 25 Chewable & Orodispersible Aids, 16 Co-Processed Excipients, 15 Emulsifying Agents, 15 Rheology Modifiers, 11 API Stability Enhancers, 8 Surfactant & Foaming Agents, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

108 Fillers, Diluents & Binders
63 Coating Systems & Additives
57 Direct Compression
54 Thickeners and Stabilizers
52 Disintegrants & Superdisintegrants
52 Controlled & Modified Release
48 Solubilizers
46 Granulation
42 Taste Masking
40 Film Formers & Plasticizers
39 Topical
32 Parenteral
30 Lubricants & Glidants
25 Chewable & Orodispersible Aids
16 Co-Processed Excipients
15 Emulsifying Agents
15 Rheology Modifiers
11 API Stability Enhancers
8 Surfactant & Foaming Agents
5 Empty Capsules
5 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 376 News #PharmaBuzz

1 Data Compilation #PharmaFlow
376 News #PharmaBuzz

GLOBAL SALES INFORMATION

96 US Medicaid Prescriptions, 314 Regulatory FDF Prices, 58 Annual Reports

96 US Medicaid Prescriptions
314 Regulatory FDF Prices
58 Annual Reports

MARKET PLACE

93 APIs, 51 FDF Dossiers

93 APIs
51 FDF Dossiers

PATENTS & EXCLUSIVITIES

656 US Patents, 54 US Exclusivities, 156 Health Canada Patents

656 US Patents
54 US Exclusivities
156 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 17 Others

3 EDQM
1 USP
17 Others

ANALYTICAL

2 BioAnalytical Methods, 1 Analytical Methods

2 BioAnalytical Methods
1 Analytical Methods

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

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150 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 2Innovata Pharmaceuticals (Pty) Ltd

18 2Kiara Health (PTY) LTD

19 3MSD (Pty) Ltd

20 5Macleods Pharmaceuticals SA (Pty) Ltd

21 2Medivision (Pty) Ltd

22 19Merck (Pty) Ltd

23 7Mylan (Pty) Ltd

24 3Novagen Pharma (Pty) Ltd

25 8Novartis South Africa (Pty) Ltd

26 3Pharmacorp (Pty) Ltd

27 7Ranbaxy Pharmaceuticals (Pty) Ltd

28 2Sandoz SA (Pty) Ltd

29 5Strides Pharma SA (Pty) Ltd

30 1Teva Pharmaceuticals (Pty) Ltd

31 6Trinity Pharma (Pty) Ltd

32 2Unicorn Pharmaceuticals (Pty) Ltd

33 4Unimed Healthcare (Pty) Ltd

34 5Viatris Healthcare (Pty) Ltd

35 8Zydus Healthcare SA (Pty) Ltd

filter Active Ingredients Reset all filters

150 All

01 7METFORMIN HYDROCHLORIDE

02 26Metformin

03 1Metformin 850 mg

04 4Metformin HCL

05 7Metformin HCl

06 9Metformin Hcl

07 69Metformin Hydrochloride

08 6Metformin Hydrochloride 500 mg

09 1Metformin Hydrochloride 850 mg

10 15Metformin hydrochloride

11 3metformin

12 2metformin hydrochloride

filter Dosage Form Reset all filters

150 All

01 2ERT

02 53FCT

03 95TAB

filter Brand Name Reset all filters

150 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 1Bigsens 1000

09 1Bigsens 500

10 1Bigsens 850

11 2Bigsens XR

12 1Bigsens XR 1 000

13 1Cadbower XR 1000

14 3Cadbower XR 500

15 1Carbuce 1000

16 1Carbuce 500

17 1Carbuce 850

18 1Carbuce XR 1000

19 1Carbuce XR 500

20 1Diabetmin Retard 850

21 1Diaformin 500 mg Tablets

22 1Diaformin Forte 850 mg Tablets

23 2Diamin-500

24 2Diamin-850

25 1Diaphage 1000

26 1Diaphage 500

27 1Diaphage 850

28 3Forminal 500

29 2Forminal 850

30 1Fortese 1g

31 1Fortese XR 500

32 2Galvus Met 50 Mg/1000Mg

33 2Galvus Met 50 Mg/850 Mg

34 1Gluconorm 500

35 1Gluconorm 850

36 5Glucophage

37 1Glucophage 1000 mg

38 2Glucophage XR 1000 mg

39 2Glucophage XR 750 mg

40 1Glucophage Xr

41 2Glucophage Xr 500 mg

42 1Glucotrin XR 1000

43 1Glucotrin XR 500

44 2Glucovance 250Mg/1.25Mg

45 2Glucovance 500Mg/2.5Mg

46 2Glucovance 500Mg/5Mg

47 2Jalramet 50/1000mg

48 2Jalramet 50/850mg

49 1Janumet 50/1000 mg

50 1Janumet 50/500 mg

51 1Janumet 50/850 mg

52 1METFORMIN TEVA ER 1 000MG

53 1METPLITIN CO 50/1 000

54 1METPLITIN CO 50/850

55 1METSITAG 50/1 000

56 1METSITAG 50/500

57 1Macloglymin 1000 mg

58 1Macloglymin 500 mg

59 1Macloglymin 850 mg

60 1Mengen 1000 mg

61 1Mengen 500 mg

62 1Mengen 850 mg

63 1Metchek 500

64 1Metchek 850

65 1Metforal 500

66 1Metforal 850

67 1Metformin 1000 XR Adco

68 1Metformin 1000 mg PharmC

69 1Metformin 1g Alkem

70 2Metformin 500 Biotech

71 1Metformin 500 mg PharmC

72 1Metformin 850 Biotech

73 1Metformin 850 mg PharmC

74 2Metformin Alkem 500 mg

75 3Metformin Alkem 850 mg

76 2Metformin Ascendis 500

77 2Metformin Ascendis 850

78 1Metformin HCl 500 FC Kiara

79 1Metformin HCl 850 FC Kiara

80 1Metformin XR 500mg Accord

81 1Metored 1000

82 1Metored 500

83 1Metored 850

84 1Metphage 500 Mg

85 1Metphage 850 Mg

86 2Mylan Metformin

87 1Mylan Metformin 1000 mg

88 6Mylan Metformin 500

89 3Mylan Metformin 850

90 1Romidab 1000 mg Tablets

91 1Romidab 500 mg Tablets

92 1Romidab 850 mg Tablets

93 1Salumet 50/1 000

94 1Salumet 50/500

95 1Sandoz Metformin Hcl 500

96 1Sandoz Metformin Hcl 850

97 1Synglutra 10/1000

98 1Synglutra 5/1000

99 1Synjardy 12,5/1000 mg

100 1Synjardy 12,5/500 mg

101 1Synjardy 12,5/850 mg

102 1Synjardy 5/1000 mg

103 1Synjardy 5/500 mg

104 1Synjardy 5/850 mg

105 2VILEPTIN CO 50/1 000

106 2VILEPTIN CO 50/850

107 1Vildamet 50/ 1000

108 1Vildamet 50/ 850

109 2Xigduo XR

Granules Metformin

List of Suppliers

Product Main Page

01

Sanofi Aventis South Africa (Pty) Ltd

CPhI WW Frankfurt

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

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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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Corporate PDF

03

Pharmacare Limited, Woodmead

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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

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04

Accord Healthcare (Pty) Ltd

PackExpo

Not Confirmed

Accord Healthcare (Pty) Ltd

PackExpo

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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

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Corporate PDF

05

Accord Healthcare (Pty) Ltd

PackExpo

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Accord Healthcare (Pty) Ltd

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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

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06

Accord Healthcare (Pty) Ltd

PackExpo

Not Confirmed

Accord Healthcare (Pty) Ltd

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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

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Adcock Ingram Limited

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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

PackExpo

Not Confirmed

Adcock Ingram Limited

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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

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09

Adcock Ingram Limited

PackExpo

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Adcock Ingram Limited

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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

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10

Arrow Pharma South Africa (Pty) Ltd

PackExpo

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Arrow Pharma South Africa (Pty) Ltd

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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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