Molecules / Busulfan

Busulfan API manufacturers

CAS 55-98-1 ATC L01AB01 Updated 9 July 2026
7
manufacturers with an active filing 7 of them hold a US DMF or a CEP
19
shortage records on file across 5 countries
151
finished-dose makers across 40 regulators
Showing 7 of 7 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Apicore

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 busulfan, filing since 2010. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
03

Excella Gmbh

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

Holds one valid CEP for busulfan, filing since 2020. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
7 markets
How this listing is sourced EDQM certificate database
View profile
04

Farmabios

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

Holds one active US DMF for busulfan, filing since 2012. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 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
05

ChemPacific

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

Holds one active US DMF for busulfan, filing since 2007. 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
06

Arthur Group

China
Makes the API

Holds one active US DMF for busulfan, 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
07

Shivalik Rasayan

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

Holds one valid CEP for busulfan, filing since 2022.

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

4 more manufacturers hold filings for busulfan

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

FarmabiosChemPacificArthur GroupShivalik Rasayan
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Finished-dose makers (18)

Otsuka Pharmaceutical India India Fresenius Kabi Ab Sweden Amneal United States Viatris United States Pharmascience Canada Pfizer Brasil Ltda Brazil Zentiva, k.s Czech Republic Apotex Canada Teva Israel Pierre Fabre Médicament; France Natco Pharma India Glaxo Wellcome S/A Spain Aspen South Africa Boston Oncology Arabia Saudi Arabia Celon Laboratories India Glaxosmithkline Brasil Ltda Brazil Laboratorio Kemex Argentina Laboratorio Varifarma S A Argentina

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 busulfan?

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

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Also on this molecule

Shortages 19 Recalls 3 Finished dose 18 Contract mfrs 0