Molecules / Sitagliptin / India

Sitagliptin API manufacturers in India

CAS 486460-32-6 ATC A10BH01 Updated 9 July 2026
29
India-based manufacturers with an active filing of 67 worldwide
$335.00
median export price per kg, all origins $230.66 to $461.57 · 40 exporters · 2025
Showing 16 of 29 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based 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
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
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
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
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
13

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
14

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
15

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
16

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

13 more manufacturers in India 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.

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How this list is built

This page filters the worldwide Sitagliptin manufacturer list to companies based in India. 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. Read the full method.

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