Molecules / Cytarabine

Cytarabine API manufacturers

CAS 147-94-4 ATC L01BC01 Updated 9 July 2026
6
manufacturers with an active filing 5 of them hold a US DMF or a CEP
37
shortage records on file across 5 countries
288
finished-dose makers across 48 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Sakar Healthcare

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

Holds one valid CEP for cytarabine, filing since 2026. Its GMP is recognised in 9 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
9 markets
How this listing is sourced EDQM certificate database
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03

Archimica

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

Holds one active US DMF for cytarabine, filing since 2011. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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04

Fujian South Pharmaceutical

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

Holds one active US DMF for cytarabine, filing since 2025. 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
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05

Suzhou Yifan Pharmaceutical

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

Holds one active US DMF for cytarabine, filing since 2025.

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
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06

Zhejiang Hisun Pharmaceutical

China
Makes the API

Registered with SFDA (Saudi Arabia) for cytarabine. 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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3 more manufacturers hold filings for cytarabine

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

Fujian South PharmaceuticalSuzhou Yifan PharmaceuticalZhejiang Hisun Pharmaceutical
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Contract manufacturers (3)

Shilpa Pharma Lifesciences India Mac Chem Products India India Revacure Lifesciences India

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

Finished-dose makers (32)

Fresenius Kabi Ab Sweden Pfizer Brasil Ltda Brazil Teva Israel Jazz Pharmaceuticals Ireland Gland Pharma India Pharmascience Canada Hospira United States Pfizer United States HIKMA ITALIA Italy Viatris United States Cipla India Microsules Argentina S A Argentina Pfizer Italia Italy Sandoz Switzerland Naprod Life Sciences India AlfaSigma Italy Eurofarma Laboratorios Brazil Fareva Unterach Austria STADA Arzneimittel Germany Baxter Oncology Germany

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 cytarabine?

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

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Also on this molecule

Shortages 37 Finished dose 32 Contract mfrs 3