Molecules / Docetaxel

Docetaxel API manufacturers

CAS 114977-28-5 ATC L01CD02 Updated 9 July 2026
29
manufacturers with an active filing 21 of them hold a US DMF or a CEP
55
shortage records on file across 10 countries
487
finished-dose makers across 51 regulators
Showing 20 of 29 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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 docetaxel, filing since 2011. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
03

Laurus Labs

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs and one valid CEP for docetaxel, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
13 markets
05

Phyton Biotech

Canada
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF and one valid CEP for docetaxel, filing since 2011. Its 2024 FDA inspection closed as VAI.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
06

Hetero

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for docetaxel, filing since 2025. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
How this listing is sourced EDQM certificate database
View profile
09

Jiangsu Hengrui Pharmaceuticals

China
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for docetaxel, filing since 2010. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
8 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

ScinoPharm Taiwan

Taiwan
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 3 active US DMFs for docetaxel, filing since 2006. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
3 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Sanofi Winthrop Industrie

France
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for docetaxel, filing since 2024. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 17 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
17 markets
How this listing is sourced EDQM certificate database
View profile
13

Fujian South Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for docetaxel, filing since 2011. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Shandong Anxin Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for docetaxel, filing since 2025. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2019 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
View profile
15

Polymed Therapeutics

United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for docetaxel, filing since 2019. Its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
View profile
16

BioVectra

Canada
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for docetaxel, filing since 2008. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
18

Yung Shin Pharmaceutical Ind

Taiwan
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for docetaxel, filing since 2012. Its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
19

Cenway Pharmaceuticals

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for docetaxel, filing since 2009.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
20

Hainan Yew Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for docetaxel, filing since 2016.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

Contract manufacturers (11)

Contract manufacturers make to order rather than holding their own filing for this molecule.

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

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