Molecules / Clofarabine

Clofarabine API manufacturers

CAS 123318-82-1 ATC L01BB06 Updated 9 July 2026
10
manufacturers with an active filing 9 of them hold a US DMF or a CEP
92
finished-dose makers across 28 regulators
Showing 10 of 10 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

MSN Laboratories

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

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

US DMF
1 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
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02

Alembic Pharmaceuticals

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

Holds one active US DMF for clofarabine, filing since 2020. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

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

Shilpa Pharma Lifesciences

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

Holds one active US DMF for clofarabine, filing since 2015. 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
04

Biophore India Pharmaceuticals

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

Holds one active US DMF for clofarabine, filing since 2014. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

ScinoPharm Taiwan

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

Holds one active US DMF for clofarabine, filing since 2014. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 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
06

Olon

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

Holds one active US DMF for clofarabine, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

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

Matrix Pharmacorp

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

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

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Guangzhou Henovcom Bioscience

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

Holds one active US DMF for clofarabine, filing since 2015.

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
09

Sionc Pharmaceuticals

India
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for clofarabine. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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10

3D Imaging Drug Design and Development

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

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

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

7 more manufacturers hold filings for clofarabine

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

Biophore India PharmaceuticalsScinoPharm TaiwanOlonMatrix PharmacorpGuangzhou Henovcom BioscienceSionc Pharmaceuticals3D Imaging Drug Design and Development
Open the full list with a free account

Contract manufacturers (3)

Shilpa Pharma Lifesciences India Olon Italy Onko İlaç Sanayi̇ Veti̇caret A.Ş Turkey

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

Finished-dose makers (13)

Genzyme United States Viatris United States Amneal United States Dr. Reddy's Laboratories India Fresenius Kabi Ab Sweden Hospira United States Zentiva, k.s Czech Republic Sanofi France Macleods Pharmaceuticals India Synthon Netherlands Aristo Pharma Germany Boston Oncology Arabia Saudi Arabia 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

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Also on this molecule

Finished dose 13 Contract mfrs 3

By country

India 9