Molecules / Exatecan

Exatecan API manufacturers

CAS 171335-80-1 Updated 9 July 2026
7
manufacturers with an active filing 7 of them hold a US DMF or a CEP
Showing 7 of 7 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Cohance Lifesciences

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

Holds 2 active US DMFs for exatecan, filing since 2026. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 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
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02

Wisdom Pharmaceutical

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

Holds one active US DMF for exatecan, filing since 2025. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
03

BrightGene Bio-Medical Technology

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

Holds one active US DMF for exatecan, filing since 2022. 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
05

Shanghai Haoyuan Chemexpress

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

Holds one active US DMF for exatecan, filing since 2022.

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
06

Shanghai Tekanbio Pharm-Tech

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

Holds one active US DMF for exatecan, filing since 2023.

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
07

Zhejiang Huida Biotech

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

Holds one active US DMF for exatecan, filing since 2022.

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

4 more manufacturers hold filings for exatecan

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

Anhui Haoyuan Pharmaceutical Co., Ltd. (Taodian Avenue Division)Shanghai Haoyuan ChemexpressShanghai Tekanbio Pharm-TechZhejiang Huida Biotech
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Contract manufacturers (4)

Sichuan Elixir Pharmaceutical China Chongqing Sintaho Pharmaceutical China Nantong Noatic Bio-Pharm Technology China Shanghai Haoyuan Chemexpress China

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

Who makes exatecan?

Ask Fred which manufacturers are on record for exatecan and what filings they hold.

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Also on this molecule

Finished dose 0 Contract mfrs 4

By country

China 6