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Saxagliptin Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

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

58 FDF Dossiers, 30 FDA Orange Book, 19 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TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

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 Chewable & Orodispersible Aids, 3 Parenteral, 3 Taste Masking, 3 Solubilizers, 3 Topical, 3 Emulsifying Agents, 2 API Stability Enhancers, 2 Coloring Agents, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

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

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
12/01/2026	Metrochem API Private Limited	India	METROCHEM API PRIVATE LTD	42492	SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE	2025-09-25	Active	II	N/A
30/12/2025	Apotex Pharmachem	Canada	APOTEX PHARMACHEM INDIA PVT LTD	27201	SAXAGLIPTIN HCI WITH MANNITOL COPRECIPITATE 20%	2013-07-05	Inactive	II	N/A

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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.

Saxagliptin Hydrochloride

Saxagliptin Hydrochloride

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

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

58 FDF Dossiers

30 FDA Orange Book

19 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**

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

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 Chewable & Orodispersible Aids

3 Parenteral

3 Taste Masking

3 Solubilizers

3 Topical

3 Emulsifying Agents

2 API Stability Enhancers

2 Coloring Agents

1 Surfactant & Foaming Agents

DIGITAL CONTENT

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