Ranked India-based API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 2 valid CEPs for duloxetine, filing since 2007. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and 2 valid CEPs for duloxetine, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
19 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 2 valid CEPs for duloxetine, filing since 2008. 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
04 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 2 valid CEPs for duloxetine, filing since 2011. 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 duloxetine, 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
06 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 4 valid CEPs for duloxetine, filing since 2010. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for duloxetine, filing since 2022. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.
Last FDA inspection
2024 · NAI
GMP recognised in
15 markets
08 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for duloxetine, filing since 2007. 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
09 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for duloxetine, filing since 2008. 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
10 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for duloxetine, filing since 2011. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
6 markets
11 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 duloxetine, filing since 2011. Its GMP is recognised in 21 markets.
Last FDA inspection
Not established
GMP recognised in
21 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for duloxetine, filing since 2024. 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
13 India
Makes the APIFinished dose
Holds 2 valid CEPs for duloxetine, filing since 2022. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 2 valid CEPs for duloxetine, filing since 2008. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for duloxetine, filing since 2008.
Last FDA inspection
Not established
GMP recognised in
Not established
12 more manufacturers in India hold filings for duloxetine
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 Duloxetine 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.