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 paclitaxel, 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 one active US DMF and one valid CEP for paclitaxel, filing since 2017. 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 2 active US DMFs and 3 valid CEPs for paclitaxel, filing since 2002. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2021 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and 2 valid CEPs for paclitaxel, filing since 2011. Its 2024 FDA inspection closed as VAI.
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
05 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for paclitaxel, filing since 2003. Its 2025 FDA inspection closed as NAI.
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for paclitaxel, filing since 2012. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 active US DMFs and one valid CEP for paclitaxel, filing since 1996.
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 and one valid CEP for paclitaxel, filing since 2021. 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 and one valid CEP for paclitaxel, filing since 2018. Its 2019 FDA inspection closed as VAI.
Last FDA inspection
2019 · VAI
GMP recognised in
Not established
10 Sweden
Makes the APIFinished dose
Registered with SFDA (Saudi Arabia) for paclitaxel. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 48 markets.
Last FDA inspection
2025 · NAI
GMP recognised in
48 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for paclitaxel, filing since 2003. 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 one active US DMF and one valid CEP for paclitaxel, filing since 2021. 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 paclitaxel, filing since 1996. Its 2021 FDA inspection closed as NAI.
Last FDA inspection
2021 · NAI
GMP recognised in
Not established
14 South Korea
Makes the APIFinished dose
Holds one active US DMF for paclitaxel, filing since 1999. Its GMP is recognised in 2 markets.
Last FDA inspection
Not established
GMP recognised in
2 markets
15 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for paclitaxel, filing since 2019. Its GMP is recognised in 2 markets.
Last FDA inspection
Not established
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for paclitaxel, filing since 2001. 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 paclitaxel, filing since 2003.
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 paclitaxel, filing since 2013.
Last FDA inspection
Not established
GMP recognised in
Not established
19 South Korea
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for paclitaxel, filing since 2026.
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 paclitaxel, filing since 2025.
Last FDA inspection
Not established
GMP recognised in
Not established
21 more manufacturers hold filings for paclitaxel
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 (10)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (53)
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.