Saxagliptin Hydrochloride | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Saxagliptin Hydrochloride
Europe

Evonik

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

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With Fermion, start the journey of your innovative API.

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Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

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Temad- We think of world-class quality.

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Saxagliptin Hydrochloride

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CHEMISTRY
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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

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

47 FDF Dossiers, 30 FDA Orange Book, 8 Europe, 9 Canada

47 FDF Dossiers
30 FDA Orange Book
8 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TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 5 DKSH, 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
5 DKSH
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, 22 Coating Systems & Additives, 19 Direct Compression, 18 Thickeners and Stabilizers, 16 Granulation, 15 Disintegrants & Superdisintegrants, 12 Lubricants & Glidants, 8 Co-Processed Excipients, 8 Controlled & Modified Release, 7 Rheology Modifiers, 6 Film Formers & Plasticizers, 3 Parenteral, 3 Taste Masking, 3 Solubilizers, 3 Topical, 3 Emulsifying Agents, 3 Chewable & Orodispersible Aids, 2 API Stability Enhancers, 2 Coloring Agents, 1 Surfactant & Foaming Agents

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

DIGITAL CONTENT

11 News #PharmaBuzz

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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FILTER :

filter Applicant Reset all filters

8 All

01 8Astrazeneca Ab

filter Active Ingredients Reset all filters

8 All

01 2Dapagliflozin Propanediol Monohydrate; Metformin Hydrochloride; Saxagliptin Hydrochloride

02 2Metformin Hydrochloride; Saxagliptin Hydrochloride

03 4Saxaglyptine Hydrochloride

filter Dosage Form Reset all filters

8 All

01 6Film Coated Tablet

02 2Modified Release Tablet

filter Country Reset all filters

8 All

01 4Spain

02 4Sweden

filter Brand Name Reset all filters

8 All

01 2Komboglyze

02 4Onglyza

03 2Qtrilmet

List of Suppliers

Product Main Page

01

Astrazeneca Ab

FNCE

Not Confirmed

Astrazeneca Ab

FNCE

Not Confirmed

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Dapagliflozin Propanediol Monohydrate; Metformin Hydrochloride; Saxagliptin Hydrochloride

Brand Name : Qtrilmet

Dosage Form : Modified Release Tablet

Dosage Strength : 1000mg;2.5mg;5mg

Packaging :

Approval Date : 11/11/2019

Application Number : 20180628000027

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Astrazeneca Ab

FNCE

Not Confirmed

Astrazeneca Ab

FNCE

Not Confirmed

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Dapagliflozin Propanediol Monohydrate; Metformin Hydrochloride; Saxagliptin Hydrochloride

Brand Name : Qtrilmet

Dosage Form : Modified Release Tablet

Dosage Strength : 850mg;2.5mg;5mg

Packaging :

Approval Date : 11/11/2019

Application Number : 20180628000010

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Astrazeneca Ab

FNCE

Not Confirmed

Astrazeneca Ab

FNCE

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Metformin Hydrochloride; Saxagliptin Hydrochloride

Brand Name : Komboglyze

Dosage Form : Film Coated Tablet

Dosage Strength : 2.5mg;1000mg

Packaging :

Approval Date : 24/11/2011

Application Number : 20100907000050

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Astrazeneca Ab

FNCE

Not Confirmed

Astrazeneca Ab

FNCE

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Metformin Hydrochloride; Saxagliptin Hydrochloride

Brand Name : Komboglyze

Dosage Form : Film Coated Tablet

Dosage Strength : 2.5mg;850mg

Packaging :

Approval Date : 24/11/2011

Application Number : 20100907000043

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Astrazeneca Ab

FNCE

Not Confirmed

Astrazeneca Ab

FNCE

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 : Authorized

Registration Country : Spain

Saxaglyptine Hydrochloride

Brand Name : Onglyza

Dosage Form : Film Coated Tablet

Dosage Strength : 5MG

Packaging :

Approval Date : 2009-11-13

Application Number : 09545006

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Astrazeneca Ab

FNCE

Not Confirmed

Astrazeneca Ab

FNCE

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 : 2024-07-18

Application Number : 09545006IP

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Astrazeneca Ab

FNCE

Not Confirmed

Astrazeneca Ab

FNCE

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 : Authorized

Registration Country : Spain

Saxaglyptine Hydrochloride

Brand Name : Onglyza

Dosage Form : Film Coated Tablet

Dosage Strength : 5MG

Packaging :

Approval Date : 2009-11-13

Application Number : 09545007

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Astrazeneca Ab

FNCE

Not Confirmed

Astrazeneca Ab

FNCE

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 : Authorized

Registration Country : Spain

Saxaglyptine Hydrochloride

Brand Name : Onglyza

Dosage Form : Film Coated Tablet

Dosage Strength : 2.5MG

Packaging :

Approval Date : 2011-03-22

Application Number : 09545012

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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