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ONGLYZA
FDA Orange Book

Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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

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Sigma-Aldrich empowers scientific discovery with top-quality solutions to accelerate research, innovation, and better health worldwide.

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Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

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TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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pharmacompass-2-m-2026-04-20

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

20 API Suppliers
12 USDMF
6 EU WC
6 NDC API
5 Listed Suppliers

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

63 FDF Dossiers, 32 FDA Orange Book, 23 Europe, 8 Canada

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EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Dr. Paul Lohmann GmbH & Co. KGaA, 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, 1 Neelkanth MineChem, 2 Nitika Pharmaceutical Specialities, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Pharmachem, 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, 17 Thickeners and Stabilizers, 16 Granulation, 14 Disintegrants & Superdisintegrants, 12 Lubricants & Glidants, 9 Co-Processed Excipients, 8 Controlled & Modified Release, 6 Film Formers & Plasticizers, 5 Rheology Modifiers, 3 Taste Masking, 3 Solubilizers, 3 Topical, 3 Emulsifying Agents, 3 Chewable & Orodispersible Aids, 3 Parenteral, 2 API Stability Enhancers, 1 Surfactant & Foaming Agents

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

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 13 News #PharmaBuzz

1 Data Compilation #PharmaFlow
13 News #PharmaBuzz

GLOBAL SALES INFORMATION

8 US Medicaid Prescriptions

8 US Medicaid Prescriptions

MARKET PLACE

2 APIs

2 APIs

PATENTS & EXCLUSIVITIES

70 US Patents, 3 US Exclusivities, 15 Health Canada Patents

70 US Patents
3 US Exclusivities
15 Health Canada Patents

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32 All

01 2AMNEAL

02 11ASTRAZENECA AB

03 2AUROBINDO PHARMA

04 3DR REDDYS LABS SA

05 2GLENMARK PHARMS LTD

06 1MSN

07 5MYLAN

08 5SUN PHARM

09 1TORRENT

filter Dosage Reset all filters

32 All

01 16TABLET, EXTENDED RELEASE;ORAL

02 16TABLET;ORAL

filter Regulatory Info Reset all filters

32 All

01 18DISCN

02 14RX

filter Brand Name Reset all filters

32 All

01 2DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE

02 3KOMBIGLYZE XR

03 2ONGLYZA

04 2QTERN

05 4QTERNMET XR

06 10SAXAGLIPTIN

07 9SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

filter RLD Reset all filters

32 All

01 21No

02 11Yes

List of Suppliers

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01

AMNEAL

PEGS Boston Summit

Not Confirmed

AMNEAL

PEGS Boston Summit

Not Confirmed

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Digital Content

RLD : No

TE Code :

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE

Approval Date : 2023-07-31

Application Number : 205941

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

AMNEAL

PEGS Boston Summit

Not Confirmed

AMNEAL

PEGS Boston Summit

Not Confirmed

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Digital Content

RLD : No

TE Code :

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2023-07-31

Application Number : 205941

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

ASTRAZENECA AB

PEGS Boston Summit

Not Confirmed

ASTRAZENECA AB

PEGS Boston Summit

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : ONGLYZA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2009-07-31

Application Number : 22350

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

ASTRAZENECA AB

PEGS Boston Summit

Not Confirmed

ASTRAZENECA AB

PEGS Boston Summit

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : ONGLYZA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2009-07-31

Application Number : 22350

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

ASTRAZENECA AB

PEGS Boston Summit

Not Confirmed

ASTRAZENECA AB

PEGS Boston Summit

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : KOMBIGLYZE XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2010-11-05

Application Number : 200678

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

ASTRAZENECA AB

PEGS Boston Summit

Not Confirmed

ASTRAZENECA AB

PEGS Boston Summit

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : KOMBIGLYZE XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2010-11-05

Application Number : 200678

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

ASTRAZENECA AB

PEGS Boston Summit

Not Confirmed

ASTRAZENECA AB

PEGS Boston Summit

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : KOMBIGLYZE XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2010-11-05

Application Number : 200678

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

AUROBINDO PHARMA

PEGS Boston Summit

Not Confirmed

AUROBINDO PHARMA

PEGS Boston Summit

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE

Approval Date : 2023-07-31

Application Number : 205972

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

AUROBINDO PHARMA

PEGS Boston Summit

Not Confirmed

AUROBINDO PHARMA

PEGS Boston Summit

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

RLD : No

TE Code : AB

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2023-07-31

Application Number : 205972

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

MYLAN

PEGS Boston Summit

Not Confirmed

MYLAN

PEGS Boston Summit

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

RLD : No

TE Code : AB

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE

Approval Date : 2023-07-31

Application Number : 205980

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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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.