Ranked India-based API manufacturers
01 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 4 active US DMFs and 2 valid CEPs for sitagliptin, filing since 2019. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
02 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.
Last FDA inspection
2025 · NAI
GMP recognised in
3 markets
03 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 5 active US DMFs and 2 valid CEPs for sitagliptin, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
29 markets
04 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and 6 valid CEPs for sitagliptin, filing since 2016. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
05 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.
Last FDA inspection
2026 · NAI
GMP recognised in
20 markets
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.
Last FDA inspection
2025 · NAI
GMP recognised in
6 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 active US DMFs and 2 valid CEPs for sitagliptin, filing since 2019. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
4 markets
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.
Last FDA inspection
2025 · VAI
GMP recognised in
13 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 2 valid CEPs for sitagliptin, filing since 2019. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2023 · NAI
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 2 valid CEPs for sitagliptin, filing since 2022. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
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.
Last FDA inspection
2019 · VAI
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for sitagliptin, filing since 2024. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2019 · VAI
GMP recognised in
1 markets
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.
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
14 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.
Last FDA inspection
2025 · VAI
GMP recognised in
14 markets
15 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.
Last FDA inspection
2025 · VAI
GMP recognised in
20 markets
16 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.
Last FDA inspection
2025 · VAI
GMP recognised in
25 markets
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.