ONGLYZA | Marketing Authorisations | MA | Europe | PharmaCompass.com

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ONGLYZA
Europe

AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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pharmacompass-1-m-2026-01-12

Evonik Health Care is the innovation hub for leading life science companies

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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pharmacompass-2-2026-02-09

ONGLYZA

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

20 API Suppliers, 12 USDMF, 6 EU WC, 6 NDC API, 5 Listed Suppliers, $ API Reference Price

20 API Suppliers
12 USDMF
6 EU WC
6 NDC API
5 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

62 FDF Dossiers, 30 FDA Orange Book, 23 Europe, 9 Canada

62 FDF Dossiers
30 FDA Orange Book
23 Europe
9 Canada

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TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 4 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 1 BASF, 1 Clariant, 5 Corel Pharma Chem, 6 DFE Pharma, 7 Gangwal Chemicals, 2 Ideal Cures, 1 Ingredion Pharma Solutions, 17 Kerry, 3 Keval Exports, 1 Kima Chemical, 13 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 10 Roquette, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 1 The Dow Chemical Company, 3 Vasa Pharmachem

1 Rochem International Inc
1 SPI Pharma
4 Gangwal Healthcare
2 Nanjing Well Pharmaceutical
1 Aeon Procare
5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 Ashland
1 BASF
1 Clariant
5 Corel Pharma Chem
6 DFE Pharma
7 Gangwal Chemicals
2 Ideal Cures
1 Ingredion Pharma Solutions
17 Kerry
3 Keval Exports
1 Kima Chemical
13 Microlex e.U
2 Nitika Pharmaceutical Specialities
1 Novo Excipients
1 Pharmatrans-Sanaq
3 Pluviaendo
3 Prachin Chemical
10 Roquette
3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
10 Sigachi Industries
3 Silverline Chemicals
1 The Dow Chemical Company
3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

31 Fillers, Diluents & Binders, 20 Coating Systems & Additives, 19 Direct Compression, 16 Granulation, 16 Thickeners and Stabilizers, 15 Disintegrants & Superdisintegrants, 12 Lubricants & Glidants, 8 Co-Processed Excipients, 8 Controlled & Modified Release, 6 Film Formers & Plasticizers, 5 Rheology Modifiers, 3 Parenteral, 3 Taste Masking, 3 Solubilizers, 3 Topical, 3 Chewable & Orodispersible Aids, 2 API Stability Enhancers, 2 Emulsifying Agents, 1 Surfactant & Foaming Agents

31 Fillers, Diluents & Binders
20 Coating Systems & Additives
19 Direct Compression
16 Granulation
16 Thickeners and Stabilizers
15 Disintegrants & Superdisintegrants
12 Lubricants & Glidants
8 Co-Processed Excipients
8 Controlled & Modified Release
6 Film Formers & Plasticizers
5 Rheology Modifiers
3 Parenteral
3 Taste Masking
3 Solubilizers
3 Topical
3 Chewable & Orodispersible Aids
2 API Stability Enhancers
2 Emulsifying Agents
1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 11 News #PharmaBuzz

1 Data Compilation #PharmaFlow
11 News #PharmaBuzz

GLOBAL SALES INFORMATION

8 US Medicaid Prescriptions

8 US Medicaid Prescriptions

MARKET PLACE

2 APIs

2 APIs

PATENTS & EXCLUSIVITIES

82 US Patents, 15 Health Canada Patents

82 US Patents
15 Health Canada Patents

$ API Ref.Price (USD/KG) : 11,666 Xls

Filters

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Filters

FILTER :

filter Applicant Reset all filters

19 All

01 10AstraZeneca AB (2)

02 8Astrazeneca Ab

03 1Orifarm AS

filter Active Ingredients Reset all filters

19 All

01 2Metformin Hydrochloride; Saxagliptin Hydrochloride

02 2Saxagliptin Hydrochloride

03 5Saxagliptin hydrochloride

04 2Saxagliptin hydrochloride; Dapagliflozin propylene glycol monohydrate

05 4Saxagliptin hydrochloride; Metformin hydrochloride

06 4Saxaglyptine Hydrochloride

filter Dosage Form Reset all filters

19 All

01 19Film Coated Tablet

filter Country Reset all filters

19 All

01 4Denmark

02 11Norway

03 4Spain

filter Brand Name Reset all filters

19 All

01 6Komboglyze

02 11Onglyza

03 2Qtern

List of Suppliers

Product Main Page

01

AstraZeneca AB (2)

ASPEN

Not Confirmed

AstraZeneca AB (2)

ASPEN

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Not Marketed

Registration Country : Norway

Saxagliptin hydrochloride

Brand Name : Onglyza

Dosage Form : Film Coated Tablet

Dosage Strength : 2.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

AstraZeneca AB (2)

ASPEN

Not Confirmed

AstraZeneca AB (2)

ASPEN

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Not Marketed

Registration Country : Norway

Saxagliptin hydrochloride

Brand Name : Onglyza

Dosage Form : Film Coated Tablet

Dosage Strength : 2.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Astrazeneca Ab

ASPEN

Not Confirmed

Astrazeneca Ab

ASPEN

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Saxaglyptine Hydrochloride

Brand Name : Onglyza

Dosage Form : Film Coated Tablet

Dosage Strength : 5MG

Packaging :

Approval Date : 13-11-2009

Application Number : 9545006

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Astrazeneca Ab

ASPEN

Not Confirmed

Astrazeneca Ab

ASPEN

Not Confirmed

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Regulatory Info : Authorized

Registration Country : Spain

Saxaglyptine Hydrochloride

Brand Name : Onglyza

Dosage Form : Film Coated Tablet

Dosage Strength : 5MG

Packaging :

Approval Date : 18-07-2024

Application Number : 09545006IP

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Astrazeneca Ab

ASPEN

Not Confirmed

Astrazeneca Ab

ASPEN

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Saxaglyptine Hydrochloride

Brand Name : Onglyza

Dosage Form : Film Coated Tablet

Dosage Strength : 5MG

Packaging :

Approval Date : 13-11-2009

Application Number : 9545007

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Astrazeneca Ab

ASPEN

Not Confirmed

Astrazeneca Ab

ASPEN

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Saxaglyptine Hydrochloride

Brand Name : Onglyza

Dosage Form : Film Coated Tablet

Dosage Strength : 2.5MG

Packaging :

Approval Date : 22-03-2011

Application Number : 9545012

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Astrazeneca Ab

ASPEN

Not Confirmed

Astrazeneca Ab

ASPEN

Not Confirmed

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Digital Content

Regulatory Info : Prescription

Registration Country : Denmark

Metformin Hydrochloride; Saxagliptin Hydrochloride

Brand Name : Komboglyze

Dosage Form : Film Coated Tablet

Dosage Strength : 2.5mg; 1000mg

Packaging :

Approval Date : 24-10-2012

Application Number : 28104745610

Regulatory Info : Prescription

Registration Country : Denmark

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Astrazeneca Ab

ASPEN

Not Confirmed

Astrazeneca Ab

ASPEN

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Prescription

Registration Country : Denmark

Metformin Hydrochloride; Saxagliptin Hydrochloride

Brand Name : Komboglyze

Dosage Form : Film Coated Tablet

Dosage Strength : 2.5mg; 850mg

Packaging :

Approval Date : 24-10-2012

Application Number : 28104745510

Regulatory Info : Prescription

Registration Country : Denmark

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Astrazeneca Ab

ASPEN

Not Confirmed

Astrazeneca Ab

ASPEN

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Prescription

Registration Country : Denmark

Saxagliptin Hydrochloride

Brand Name : Onglyza

Dosage Form : Film Coated Tablet

Dosage Strength : 2.5mg

Packaging :

Approval Date : 28-02-2011

Application Number : 28104680910

Regulatory Info : Prescription

Registration Country : Denmark

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Astrazeneca Ab

ASPEN

Not Confirmed

Astrazeneca Ab

ASPEN

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

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Digital Content

Regulatory Info : Prescription

Registration Country : Denmark

Saxagliptin Hydrochloride

Brand Name : Onglyza

Dosage Form : Film Coated Tablet

Dosage Strength : 5mg

Packaging :

Approval Date : 01-10-2009

Application Number : 28104387208

Regulatory Info : Prescription

Registration Country : Denmark

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.