Molecules / Azathioprine

Azathioprine API manufacturers

CAS 446-86-6 ATC L04AX01 Updated 9 July 2026
11
manufacturers with an active filing 11 of them hold a US DMF or a CEP
$247.16
median export price per kg $133.07 to $370.17 · 6 exporters · 2025
21
shortage records on file across 5 countries
248
finished-dose makers across 47 regulators
Showing 11 of 11 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Zydus Lifesciences

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

Holds one active US DMF and one valid CEP for azathioprine, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
25 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
02

Fermion Oy

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

Holds one active US DMF and one valid CEP for azathioprine, filing since 1984. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
05

Excella Gmbh

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

Holds one valid CEP for azathioprine, filing since 2016. 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
06

Raks Pharma

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

Holds 2 active US DMFs for azathioprine, filing since 2009. Its 2025 FDA inspection closed as NAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Fine Chemicals Corporation (PTY)

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

Holds 2 active US DMFs for azathioprine, filing since 1993. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Aarti Pharmalabs

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

Holds one active US DMF for azathioprine, filing since 2009. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Matrix Pharmacorp

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

Holds one active US DMF for azathioprine, filing since 2010. 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
10

Zhejiang Cheng Yi Pharmaceutical

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

Holds one active US DMF for azathioprine, 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
11

APICHEM Laboratories

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

Holds one active US DMF for azathioprine, filing since 2024. 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

8 more manufacturers hold filings for azathioprine

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

Resolution ChemicalsExcella GmbhRaks PharmaFine Chemicals Corporation (PTY)Aarti PharmalabsMatrix PharmacorpZhejiang Cheng Yi PharmaceuticalAPICHEM Laboratories
Open the full list with a free account

Contract manufacturers (2)

Fermion Oy Finland Rakshit Drugs India

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

Finished-dose makers (28)

Glenmark Pharmaceuticals s.r.o Czech Republic HIKMA ITALIA Italy Viatris United States Apotex Canada Douglas Manufacturing New Zealand Teva Israel Sandoz Switzerland Amneal Pharmaceuticals NY United States Granules India India Medac Gesellschaft für klinische Spezialpräparate mbH; Germany Pharmachemie Netherlands Sebela Pharmaceuticals United States Aspen South Africa Aqvida Germany Alkem Laboratories India Glaxo Wellcome S/A Spain Nova Laboratories United Kingdom Remedica Cyprus Acdima International Trading Egypt Acino Pharma Switzerland

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
Price band
Customs export unit values for 2025. These are export values rather than contract prices for regulated-market grade material, which are higher.

Map azathioprine for your markets

Tell us which markets you need to file in. These suppliers come back tiered for those markets, with the price corridor and an RFI sheet.

Start for free
No sales call.

Also on this molecule

Price history 3 yrs Shortages 21 Recalls 2 Finished dose 28 Contract mfrs 2

By country

India 10

Export price by year

Year Median Exporters
2025 $247.16 6
2024 $300.00 7
2023 $300.00 6

US dollars per kilogram, customs export unit values.