Ranked API manufacturers
01 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 erlotinib, filing since 2012. 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
02 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and one valid CEP for erlotinib, filing since 2013. 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
03 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for erlotinib, filing since 2012. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 13 markets.
Last FDA inspection
2022 · NAI
GMP recognised in
13 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for erlotinib, filing since 2015. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 14 markets.
Last FDA inspection
2025 · NAI
GMP recognised in
14 markets
05 Canada
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for erlotinib, filing since 2013. 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
06 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for erlotinib, filing since 2015. 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
07 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for erlotinib, filing since 2016. 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 2 active US DMFs for erlotinib, filing since 2020. 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
09 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for erlotinib, filing since 2008. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
15 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for erlotinib, filing since 2015. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for erlotinib, filing since 2012. Its 2025 FDA inspection closed as NAI.
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
12 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for erlotinib, filing since 2015. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
13 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for erlotinib, filing since 2018. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
Registered with SFDA (Saudi Arabia) for erlotinib.
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile Registered with DAV (Vietnam) for erlotinib. Its GMP is recognised in 2 markets.
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 16 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for erlotinib. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 13 more manufacturers hold filings for erlotinib
The names are listed below. Ask Fred about the filings, inspection history and GMP
certificates on record for each manufacturer.
Chat with Fred, your AI analyst Contract manufacturers (6)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (52)
How this list is built
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.
Every factor appears on the card it produced.
Read the full method.
- Active US DMFs
- FDA, List of Drug Master Files
- Valid CEPs
- EDQM certificate database
- Inspection outcomes
- FDA inspection classifications
- GMP certificates
- EudraGMDP and national regulators
- Price band
-
Customs export unit values for 2023. These are export values rather than
contract prices for regulated-market grade material, which are higher.