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 4 valid CEPs for azithromycin, filing since 2005. 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
02 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for azithromycin, filing since 2012. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for azithromycin, filing since 2020. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.
Last FDA inspection
2023 · NAI
GMP recognised in
3 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for azithromycin, filing since 2020. 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
Holds 4 active US DMFs for azithromycin, filing since 2005. 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 azithromycin, filing since 2016. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for azithromycin, filing since 2013.
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 azithromycin, filing since 2013. 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
7 more manufacturers in India hold filings for azithromycin
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 Azithromycin 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.