Molecules / Cabazitaxel

Cabazitaxel API manufacturers

CAS 183133-96-2 ATC L01CD04 Updated 9 July 2026
15
manufacturers with an active filing 14 of them hold a US DMF or a CEP
10
shortage records on file across 5 countries
310
finished-dose makers across 42 regulators
Showing 15 of 15 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hetero

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

Holds one active US DMF for cabazitaxel, filing since 2014. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Dr. Reddy's Laboratories

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

Holds one active US DMF for cabazitaxel, filing since 2014. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

MSN Laboratories

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

Holds 2 active US DMFs for cabazitaxel, filing since 2014. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Laurus Labs

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

Holds 2 active US DMFs for cabazitaxel, filing since 2014. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
13 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Shandong New Time Pharmaceutical

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

Holds one active US DMF for cabazitaxel, filing since 2024. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Sanofi

France
Makes the API

Holds one active US DMF for cabazitaxel, filing since 2010. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 33 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
33 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Shilpa Pharma Lifesciences

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

Holds one active US DMF for cabazitaxel, filing since 2020. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Sichuan Xieli Pharmaceutical

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

Holds one active US DMF for cabazitaxel, filing since 2012. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Sichuan Elixir Pharmaceutical

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

Holds one active US DMF for cabazitaxel, filing since 2024. Its GMP is recognised in 5 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
5 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Indena

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

Holds 4 active US DMFs for cabazitaxel, filing since 2020. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
4 active
CEP
None on file
Last FDA inspection
2021 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Qilu Pharmaceutical

China
Makes the API

Registered with SFDA (Saudi Arabia) for cabazitaxel. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 7 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
7 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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12

Shandong Anhong Pharmaceutical

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

Holds one active US DMF for cabazitaxel, filing since 2013. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Tianjin Weijie Pharmaceutical

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

Holds one active US DMF for cabazitaxel, filing since 2016. Its 2024 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Jiangsu Xidi Pharmaceuticals

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

Holds one active US DMF for cabazitaxel, filing since 2025. 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
15

Yung Shin Pharmaceutical Ind

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

Holds one active US DMF for cabazitaxel, filing since 2020. 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

12 more manufacturers hold filings for cabazitaxel

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

Laurus LabsShandong New Time PharmaceuticalSanofiShilpa Pharma LifesciencesSichuan Xieli PharmaceuticalSichuan Elixir PharmaceuticalIndenaQilu PharmaceuticalShandong Anhong PharmaceuticalTianjin Weijie PharmaceuticalJiangsu Xidi PharmaceuticalsYung Shin Pharmaceutical Ind
Open the full list with a free account

Contract manufacturers (4)

Shilpa Pharma Lifesciences India Indena Italy Ever Neuro Pharma Austria Lgm Pharma United States

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

Finished-dose makers (29)

Fresenius Kabi Ab Sweden Zentiva, k.s Czech Republic Glenmark Pharmaceuticals s.r.o Czech Republic Viatris United States Apotex Canada Teva Israel Sanofi Winthrop Industrie France Sandoz Switzerland Eurofarma Laboratorios Brazil MSN Laboratories India Medac Gesellschaft für klinische Spezialpräparate mbH; Germany Ever Valinject Austria Aqvida Germany BDR Lifesciences India Ever Pharma Jena Germany STADA Arzneimittel Germany Glenmark Generics Argentina Mylan Dublin Ireland

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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Also on this molecule

Shortages 10 Recalls 4 Finished dose 29 Contract mfrs 4

By country

China 14 India 7