Glifage | Australian Register of Therapeutic Goods | Australia | PharmaCompass.com

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Glifage
Australia

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Glifage

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

177 API Suppliers, 57 USDMF, 43 CEP/COS, 13 JDMF, 31 EU WC, 99 KDMF, 39 NDC API, 45 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

33 Drugs in Development

33 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1957 FDF Dossiers, 425 FDA Orange Book, 534 Europe, 134 Canada, 164 Australia, 140 South Africa, 560 Listed Dossiers

1957 FDF Dossiers
425 FDA Orange Book
534 Europe
134 Canada
164 Australia
140 South Africa
560 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TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;1GM, TABLET;ORAL - 2.5MG;500MG, TABLET;ORAL - 2.5MG;850MG, TABLET;ORAL - EQ 12.5MG BASE;1GM,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- EQ 12.5MG BASE;500MG, TABLET;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 150MG;1GM, TABLET, EXTENDED RELEASE;ORAL - 150MG;500MG, TABLET, EXTENDED RELEASE;ORAL -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, 2 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 39 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 5 Lubrizol Life Science Health, 22 Microlex e.U, 2 Nanjing Bold Chemical, 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

122 Fillers, Diluents & Binders, 65 Coating Systems & Additives, 56 Controlled & Modified Release, 52 Thickeners and Stabilizers, 51 Disintegrants & Superdisintegrants, 51 Direct Compression, 48 Solubilizers, 42 Taste Masking, 41 Granulation, 40 Film Formers & Plasticizers, 38 Topical, 30 Parenteral, 29 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 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 1 Soft Gelatin

122 Fillers, Diluents & Binders
65 Coating Systems & Additives
56 Controlled & Modified Release
52 Thickeners and Stabilizers
51 Disintegrants & Superdisintegrants
51 Direct Compression
48 Solubilizers
42 Taste Masking
41 Granulation
40 Film Formers & Plasticizers
38 Topical
30 Parenteral
29 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 Coloring Agents
5 Empty Capsules
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 373 News #PharmaBuzz

1 Data Compilation #PharmaFlow
373 News #PharmaBuzz

GLOBAL SALES INFORMATION

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

3 US Medicaid Prescriptions
494 Regulatory FDF Prices
25 Annual Reports

MARKET PLACE

90 APIs, 51 FDF Dossiers

90 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 :

filter Applicant Reset all filters

164 All

01 34Alphapharm Pty Ltd

02 10Apotex Pty Ltd

03 16Arrotex Pharmaceuticals Pty Ltd

04 10Arrow Pharma Pty Ltd

05 12AstraZeneca

06 14Boehringer Ingelheim GmbH

07 4Generic Health Pty Ltd

08 6Novartis Pharmaceuticals Corporation

09 10Pharmacor Pty Limited

10 26Sandoz Pty Ltd

11 6Sun Pharma ANZ Pty Ltd

12 6Takeda Pharmaceutical

13 10WAGNER PHARMACEUTICALS PTY LTD

filter Active Ingredients Reset all filters

164 All

01 6Alogliptin; Metformin

02 6Dapagliflozin; Metformin

03 8Empagliflozin; Metformin

04 6Linagliptin; Metformin

05 82Metformin

06 6Saxagliptin; Metformin

07 44Sitagliptin + metformin

08 6Vildagliptin; Metformin

filter Dosage Form Reset all filters

164 All

01 32Tablet

02 92tablet

03 40Blank

filter Brand Name Reset all filters

164 All

01 2APO-Metformin XR 1000

02 2APO-Metformin XR 500

03 6APX-METFORMIN

04 2Blooms The Chemist Metformin 1000 mg

05 2Blooms The Chemist Metformin 500 mg

06 2Blooms The Chemist Metformin 850 mg

07 2Diabex

08 2Diabex 1000

09 2Diabex 850

10 2Diabex XR 1000

11 2Diabex XR 500

12 2Diaformin

13 2Diaformin 1000

14 2Diaformin 850

15 4Diaformin Alphapharm XR

16 6Diaformin Viatris

17 2Diaformin XR 1000

18 2FORMET 500

19 2FORMET 850

20 2Formet 1000

21 2Galvumet 50/1000

22 2Galvumet 50/500

23 2Galvumet 50/850

24 6Janumet

25 4Janumet XR

26 2Jardiamet 12.5 mg/1000 mg

27 2Jardiamet 12.5 mg/500 mg

28 2Jardiamet 5 mg/1000 mg

29 2Jardiamet 5 mg/500 mg

30 2Kombiglyze XR 2.5/1000

31 2Kombiglyze XR 5/1000

32 2Kombiglyze XR 5/500

33 2METEX XR

34 6METFORMIN-WGR

35 4METFORMIN-WGR XR

36 2Metex XR

37 4Metformin GH

38 6Metformin Sandoz

39 4Metformin Sandoz XR

40 2Nesina Met 12.5/1000

41 2Nesina Met 12.5/500

42 2Nesina Met 12.5/850

43 4Pharmacor Metformin XR

44 2SITAGLIPTIN/METFORMIN 50/1000 SUN

45 2SITAGLIPTIN/METFORMIN 50/500 SUN

46 2SITAGLIPTIN/METFORMIN 50/850 SUN

47 6SITAGLO-MET

48 2Sitagliptin/Metformin Mylan 50/1000

49 2Sitagliptin/Metformin Mylan 50/500

50 2Sitagliptin/Metformin Mylan 50/850

51 6Sitagliptin/Metformin Sandoz

52 4Sitagliptin/Metformin Sandoz XR

53 6Trajentamet

54 6Velmetia

55 2Xigduo XR 10/1000

56 2Xigduo XR 10/500

57 2Xigduo XR 5/1000

Granules Metformin

List of Suppliers

Product Main Page

01

AstraZeneca

FCE Pharma

Not Confirmed

AstraZeneca

FCE Pharma

Not Confirmed

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Regulatory Info :

Registration Country : Australia

Saxagliptin; Metformin

Brand Name : Kombiglyze XR 2.5/1000

Dosage Form : Tablet

Dosage Strength : 2.5MG

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

AstraZeneca

FCE Pharma

Not Confirmed

AstraZeneca

FCE Pharma

Not Confirmed

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Regulatory Info :

Registration Country : Australia

Saxagliptin; Metformin

Brand Name : Kombiglyze XR 5/1000

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

AstraZeneca

FCE Pharma

Not Confirmed

AstraZeneca

FCE Pharma

Not Confirmed

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Regulatory Info :

Registration Country : Australia

Saxagliptin; Metformin

Brand Name : Kombiglyze XR 5/500

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Boehringer Ingelheim GmbH

FCE Pharma

Not Confirmed

Boehringer Ingelheim GmbH

FCE Pharma

Not Confirmed

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Regulatory Info :

Registration Country : Australia

Linagliptin; Metformin

Brand Name : Trajentamet

Dosage Form : Tablet

Dosage Strength : 2.5MG

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Boehringer Ingelheim GmbH

FCE Pharma

Not Confirmed

Boehringer Ingelheim GmbH

FCE Pharma

Not Confirmed

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Regulatory Info :

Registration Country : Australia

Linagliptin; Metformin

Brand Name : Trajentamet

Dosage Form : Tablet

Dosage Strength : 2.5MG

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Boehringer Ingelheim GmbH

FCE Pharma

Not Confirmed

Boehringer Ingelheim GmbH

FCE Pharma

Not Confirmed

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Regulatory Info :

Registration Country : Australia

Linagliptin; Metformin

Brand Name : Trajentamet

Dosage Form : Tablet

Dosage Strength : 2.5MG

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Sandoz Pty Ltd

FCE Pharma

Not Confirmed

Sandoz Pty Ltd

FCE Pharma

Not Confirmed

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Regulatory Info :

Registration Country : Australia

Sitagliptin + metformin

Brand Name : Sitagliptin/Metformin Sandoz XR

Dosage Form : tablet

Dosage Strength : 100 mg + 1 g

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Product Web Link

Digital Content

08

Takeda Pharmaceutical

FCE Pharma

Not Confirmed

Takeda Pharmaceutical

FCE Pharma

Not Confirmed

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Regulatory Info :

Registration Country : Australia

Alogliptin; Metformin

Brand Name : Nesina Met 12.5/850

Dosage Form : Tablet

Dosage Strength : 12.5MG

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

09

Takeda Pharmaceutical

FCE Pharma

Not Confirmed

Takeda Pharmaceutical

FCE Pharma

Not Confirmed

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Regulatory Info :

Registration Country : Australia

Alogliptin; Metformin

Brand Name : Nesina Met 12.5/500

Dosage Form : Tablet

Dosage Strength : 12.5MG

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

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Digital Content

10

Takeda Pharmaceutical

FCE Pharma

Not Confirmed

Takeda Pharmaceutical

FCE Pharma

Not Confirmed

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Regulatory Info :

Registration Country : Australia

Alogliptin; Metformin

Brand Name : Nesina Met 12.5/1000

Dosage Form : Tablet

Dosage Strength : 12.5MG

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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