Molecules / Saxagliptin

Saxagliptin API manufacturers

CAS 361442-04-8 ATC A10BH03 · DPP-4 inhibitors Updated 9 July 2026
18
manufacturers with an active filing 15 of them hold a US DMF or a CEP
$13667.00
median export price per kg $8992.50 to $15640.25 · 6 exporters · 2024
17
shortage records on file across 4 countries
102
finished-dose makers across 30 regulators
Showing 18 of 18 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for saxagliptin, filing since 2013. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Synthimed Labs

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for saxagliptin, filing since 2026. Its 2020 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2020 · NAI
GMP recognised in
15 markets
How this listing is sourced EDQM certificate database
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03

Alivus Life Sciences

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for saxagliptin, filing since 2013. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Morepen Laboratories

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for saxagliptin, filing since 2019. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Raks Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for saxagliptin, filing since 2013. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
06

CTX Lifesciences

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for saxagliptin, filing since 2024. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Apitoria Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for saxagliptin, filing since 2013. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Bristol-Myers Squibb

United States
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for saxagliptin. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 49 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
49 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
09

MSN Laboratories

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 4 active US DMFs for saxagliptin, filing since 2013. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
4 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Matrix Pharmacorp

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for saxagliptin, filing since 2013. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Zhejiang Supor Pharmaceuticals

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for saxagliptin, filing since 2022. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Wockhardt Bio

Switzerland
Makes the API

Holds one active US DMF for saxagliptin, filing since 2013. Its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

BrightGene Bio-Medical Technology

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for saxagliptin, filing since 2024. Its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Fuxin Long Rui Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for saxagliptin, filing since 2019. Its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
16

Synthetics China

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for saxagliptin, filing since 2017.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
17

Viyash Life Sciences

India
Makes the API

Registered with SFDA (Saudi Arabia) for saxagliptin. Its 2025 FDA inspection closed as VAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
18

Pharbaco

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for saxagliptin. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

15 more manufacturers hold filings for saxagliptin

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

Morepen LaboratoriesRaks PharmaCTX LifesciencesApitoria PharmaBristol-Myers SquibbMSN LaboratoriesMatrix PharmacorpZhejiang Supor PharmaceuticalsWockhardt BioBrightGene Bio-Medical TechnologyFuxin Long Rui PharmaceuticalBeijing Huikang Boyuan Chemical TechSynthetics ChinaViyash Life SciencesPharbaco
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Contract manufacturers (5)

Lee Pharma India Morepen Laboratories India CTX Lifesciences India Metrochem API India Chengdu Baishixing Science And Technology Industry China

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (34)

Glenmark Pharmaceuticals s.r.o Czech Republic Viatris United States Astrazeneca Ab Sweden Astrazeneca Pharmaceuticals Lp United States Torrent Pharmaceuticals India Amneal United States Apotex Canada Boehringer Ingelheim Pharma Gmbh Germany Zentiva, k.s Czech Republic Cipla India Exemed Pharmaceuticals India Inventia Healthcare India Macleods Pharmaceuticals India Micro Labs India Optimus Drugs India USV India Zydus Lifesciences India Akums Drugs & Pharmaceuticals India Alkem Laboratories India AstraZeneca UK United Kingdom

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators
Price band
Customs export unit values for 2024. These are export values rather than contract prices for regulated-market grade material, which are higher.

Who makes saxagliptin?

Ask Fred which manufacturers are on record for saxagliptin and what filings they hold.

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Also on this molecule

Price history 2 yrs Shortages 17 Recalls 3 Finished dose 34 Contract mfrs 5

By country

India 10 China 5

Sold in these combinations

Metformin + Saxagliptin 2 APIs

Fixed-dose combinations containing saxagliptin. Each page leads with the verified API makers of every component.

Export price by year

Year Median Exporters
2024 $13667.00 6
2022 $24779.38 5

US dollars per kilogram, customs export unit values.