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 capecitabine, filing since 2009. 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
02 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 capecitabine, filing since 2012. 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 and one valid CEP for capecitabine, filing since 2008. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for capecitabine, filing since 2011. 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 and one valid CEP for capecitabine, filing since 2013. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2019 · VAI
GMP recognised in
2 markets
06 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for capecitabine, filing since 2010. 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
07 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for capecitabine, filing since 2021. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2025 · NAI
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for capecitabine, filing since 2011. 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 capecitabine, filing since 2011. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for capecitabine, filing since 2009. 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 capecitabine, filing since 2010. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2022 · NAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for capecitabine, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
13 Germany
Makes the APIFinished dose
Registered with SFDA (Saudi Arabia) for capecitabine. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.
Last FDA inspection
2022 · VAI
GMP recognised in
7 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for capecitabine, filing since 2013.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for capecitabine, filing since 2008.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for capecitabine, filing since 2024.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for capecitabine, filing since 2023.
Last FDA inspection
Not established
GMP recognised in
Not established
Registered with PMDA (Japan) for capecitabine.
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 19 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for capecitabine. 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 16 more manufacturers hold filings for capecitabine
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 Contract manufacturers (3)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (42)
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 2025. These are export values rather than
contract prices for regulated-market grade material, which are higher.