Molecules / Sitagliptin

Sitagliptin API manufacturers

CAS 486460-32-6 ATC A10BH01 · DPP-4 inhibitors Updated 9 July 2026
67
manufacturers with an active filing 51 of them hold a US DMF or a CEP
$335.00
median export price per kg $230.66 to $461.57 · 40 exporters · 2025
172
shortage records on file across 9 countries
1,215
finished-dose makers across 54 regulators
Showing 20 of 67 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Harman Finochem

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

Holds one active US DMF and one valid CEP for sitagliptin, filing since 2016. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
3 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
05

Torrent Pharmaceuticals

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

Holds one active US DMF and one valid CEP for sitagliptin, filing since 2018. Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 20 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2026 · NAI
GMP recognised in
20 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
06

Lee Pharma

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

Holds 2 active US DMFs and one valid CEP for sitagliptin, filing since 2020. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 6 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
6 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
08

Laurus Labs

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

Holds 2 active US DMFs and one valid CEP for sitagliptin, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
13 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
11

Honour Lab

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

Holds 2 active US DMFs and one valid CEP for sitagliptin, filing since 2016. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2019 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
13

Apotex

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

Holds one active US DMF for sitagliptin, filing since 2010. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Lupin

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

Holds one active US DMF for sitagliptin, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Ruyuan Hec Pharm

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

Holds 3 active US DMFs for sitagliptin, filing since 2016. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
3 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
16

Glenmark Pharmaceuticals s.r.o

Czech Republic
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for sitagliptin. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 40 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
40 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
17

Mankind Pharma

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

Holds 2 active US DMFs for sitagliptin, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 14 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
14 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
18

Micro Labs

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

Holds 4 valid CEPs for sitagliptin, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 20 markets.

US DMF
None on file
CEP
4 valid
Last FDA inspection
2025 · VAI
GMP recognised in
20 markets
How this listing is sourced EDQM certificate database
EDQM certificate database
View profile
19

Shandong New Time Pharmaceutical

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

Holds one active US DMF for sitagliptin, filing since 2022. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
20

Zydus Lifesciences

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

Holds 3 active US DMFs for sitagliptin, filing since 2014. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

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

64 more manufacturers hold filings for sitagliptin

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

Macleods PharmaceuticalsTorrent PharmaceuticalsLee PharmaMSN Life SciencesLaurus LabsMorepen LaboratoriesAmi LifesciencesHonour LabIOL Chemicals and PharmaceuticalsApotexLupinRuyuan Hec PharmGlenmark Pharmaceuticals s.r.oMankind PharmaMicro LabsShandong New Time PharmaceuticalZydus Lifesciences
Open the full list with a free account

Contract manufacturers (18)

Morepen Laboratories India Hikal India Bajaj Healthcare India Viwit Pharmaceutical China Chengda Pharmaceuticals China Corona Remedies India Finecure pharmaceuticals India zhejiang jiuzhou pharmaceutical China Baroque Pharmaceuticals India Hunan Jiudian Hongyang Pharmaceutical China Next Wave India India Bangkok Lab And Cosmetics Public Thailand Chemex Global India Grupo Azevedos Portugal Pharmaline 3 Lebanon Pharmazac Greece Polpharma Group Poland Simson Pharma India

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

Finished-dose makers (97)

Zentiva, k.s Czech Republic Hetero India Natco Pharma India Organon Pharma (Uk) United Kingdom Pharmascience Canada Taro Pharmaceuticals Israel Sandoz Switzerland Olpha Latvia Incepta Pharmaceuticals Bangladesh Viatris United States Mylan Pharmaceuticals United States Ajanta Pharma India Boehringer Ingelheim Pharma Gmbh Germany Teva Israel Cipla India Inventia Healthcare India Getz Pharma Pakistan Towa Pharmaceutical Europe, S.L Spain Exemed Pharmaceuticals India MSN Laboratories India

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 2025. These are export values rather than contract prices for regulated-market grade material, which are higher.

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Also on this molecule

Price history 4 yrs Shortages 172 Recalls 10 Finished dose 97 Contract mfrs 18

By country

India 29

Export price by year

Year Median Exporters
2025 $335.00 40
2024 $375.00 55
2023 $500.00 59
2022 $699.96 38

US dollars per kilogram, customs export unit values.