Ranked India-based API manufacturers
01 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and 3 valid CEPs for esomeprazole, 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
02 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 active US DMFs and 3 valid CEPs for esomeprazole, filing since 2010. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 active US DMFs and 3 valid CEPs for esomeprazole, filing since 2015. 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
04 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 8 valid CEPs for esomeprazole, filing since 2005. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 4 active US DMFs and 2 valid CEPs for esomeprazole, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
7 markets
06 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 active US DMFs and one valid CEP for esomeprazole, filing since 2008. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds 8 active US DMFs and one valid CEP for esomeprazole, filing since 2007. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
08 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 6 active US DMFs for esomeprazole, filing since 2020. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
Holds one active US DMF and one valid CEP for esomeprazole, filing since 2018. Its 2019 FDA inspection closed as NAI.
Last FDA inspection
2019 · NAI
GMP recognised in
Not established
10 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for esomeprazole, filing since 2009. 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
11 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for esomeprazole, filing since 2014. 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
Holds 6 valid CEPs for esomeprazole, filing since 2021. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
6 markets
13 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for esomeprazole, filing since 2014. Its GMP is recognised in 21 markets.
Last FDA inspection
Not established
GMP recognised in
21 markets
14 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for esomeprazole, filing since 2018. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
11 more manufacturers in India hold filings for esomeprazole
The names are listed below. The filings, inspection history and GMP certificates behind
each one are available with a free account.
Open the full list with a free account How this list is built
This page filters the worldwide Esomeprazole 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.