Molecules / Decitabine

Decitabine API manufacturers

CAS 2353-33-5 ATC L01BC08 Updated 9 July 2026
13
manufacturers with an active filing 13 of them hold a US DMF or a CEP
1
shortage records on file across 1 countries
150
finished-dose makers across 31 regulators
Showing 13 of 13 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

“Reliance Life Sciences

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

Holds one active US DMF for decitabine, filing since 2016. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 13 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
13 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
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 decitabine, filing since 2010. 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

Qilu Pharmaceutical

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

Holds one active US DMF for decitabine, filing since 2015. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 7 markets.

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

MSN Laboratories

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

Holds one active US DMF for decitabine, filing since 2017. 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
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 decitabine, 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

Shilpa Pharma Lifesciences

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

Holds one active US DMF for decitabine, filing since 2013. 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
07

Biophore India Pharmaceuticals

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

Holds one active US DMF for decitabine, filing since 2015. 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
08

Farmhispania

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

Holds one active US DMF for decitabine, filing since 2019. 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
View profile
09
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for decitabine, filing since 2018. Its GMP is recognised in 4 markets.

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

Itf Chemical Ltda

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

Holds one active US DMF for decitabine, filing since 2012. 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
11

ScinoPharm Taiwan

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

Holds 2 active US DMFs for decitabine, filing since 2009. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 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
12

Wuhan Calmland Pharmaceuticals

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

Holds one active US DMF for decitabine, filing since 2017. Its 2019 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Veranova Lp

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

Holds one active US DMF for decitabine, filing since 2011.

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

10 more manufacturers hold filings for decitabine

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

MSN LaboratoriesShandong New Time PharmaceuticalShilpa Pharma LifesciencesBiophore India PharmaceuticalsFarmhispaniaJiangsu Hansoh Pharmaceutical GroupItf Chemical LtdaScinoPharm TaiwanWuhan Calmland PharmaceuticalsVeranova Lp
Open the full list with a free account

Contract manufacturers (6)

Biophore India Pharmaceuticals India Shilpa Pharma Lifesciences India Zhejiang Haizhou Pharmaceutical China Farmhispania Group Spain 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 (22)

Amneal United States HIKMA ITALIA Italy Viatris United States Otsuka Pharmaceutical India India Gland Pharma India Nivagen Pharmaceuticals United States Hetero India Bsp Pharmaceuticals Italy Cipla India Eurofarma Laboratorios Brazil Lupin India Pendopharm Canada Pfizer Brasil Ltda Brazil Sandoz Switzerland Zydus Lifesciences India Eriochem Argentina Janssen-Cilag Farmaceutica Ltda Brazil Seacross Pharma (Europe) United Kingdom Ever Valinject Austria Laboratorio Lkm 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

Shortages 1 Recalls 1 Finished dose 22 Contract mfrs 6

By country

India 8 China 7