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 2 valid CEPs for cetirizine, filing since 2005. 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 one active US DMF and 2 valid CEPs for cetirizine, filing since 2012. 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
03 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and 4 valid CEPs for cetirizine, filing since 2000. 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 2 active US DMFs and 2 valid CEPs for cetirizine, filing since 2016. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for cetirizine, filing since 2007. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
Holds 2 active US DMFs and one valid CEP for cetirizine, filing since 2024.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for cetirizine, filing since 2006. Its 2024 FDA inspection closed as VAI.
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for cetirizine, filing since 2024. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for cetirizine, filing since 2007.
Last FDA inspection
Not established
GMP recognised in
Not established
Holds 2 active US DMFs for cetirizine, filing since 2007. Its 2022 FDA inspection closed as VAI.
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for cetirizine, filing since 2004. 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 cetirizine, filing since 2008. Its 2024 FDA inspection closed as OAI, and its GMP is recognised in 1 market.
Last FDA inspection
2024 · OAI
GMP recognised in
1 markets
9 more manufacturers in India hold filings for cetirizine
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 Cetirizine 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.