Molecules / Ruxolitinib

Ruxolitinib API manufacturers

CAS 941678-49-5 ATC L01XE18 Updated 9 July 2026
14
manufacturers with an active filing 13 of them hold a US DMF or a CEP
$19242.72
median export price per kg $16729.37 to $32000.00 · 7 exporters · 2024
89
finished-dose makers across 39 regulators
Showing 14 of 14 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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

Holds 3 active US DMFs for ruxolitinib, filing since 2024. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
3 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
02

MSN Laboratories

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

Holds 5 active US DMFs for ruxolitinib, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
5 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
03

Alembic Pharmaceuticals

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

Holds one active US DMF for ruxolitinib, filing since 2025. 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
04

Cipla

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

Holds one active US DMF for ruxolitinib, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Granules India

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

Holds 2 active US DMFs for ruxolitinib, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
7 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Natco Pharma

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

Holds 2 active US DMFs for ruxolitinib, filing since 2026. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.

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

Alivus Life Sciences

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

Holds 2 active US DMFs for ruxolitinib, filing since 2025. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 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
08

Biophore India Pharmaceuticals

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

Holds one active US DMF for ruxolitinib, filing since 2024. 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
09

Changzhou Pharmaceutical Factory

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

Holds 6 active US DMFs for ruxolitinib, filing since 2024. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
6 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Valary Lab

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

Holds 3 active US DMFs for ruxolitinib, filing since 2025. Its 2024 FDA inspection closed as VAI.

US DMF
3 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
12

Ampac Fine Chemicals

United States
Makes the API

Registered with SFDA (Saudi Arabia) for ruxolitinib. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
14

Devi Pharmatech

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

Holds one active US DMF for ruxolitinib, 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
View profile

11 more manufacturers hold filings for ruxolitinib

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

CiplaGranules IndiaNatco PharmaAlivus Life SciencesBiophore India PharmaceuticalsChangzhou Pharmaceutical FactoryChongqing Huapont Shengchem PharmaceuticalValary LabAmpac Fine ChemicalsChongqing Huapont PharmaceuticalDevi Pharmatech
Open the full list with a free account

Contract manufacturers (2)

Granules India India Simson Pharma India

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

Finished-dose makers (6)

Novartis Switzerland Medichem Spain Novartis Farmacéutica, S. A Spain Orion Finland Hikma Pharmaceuticals Jordan Jazeera Pharmaceutical Industries Saudi Arabia

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 2024. These are export values rather than contract prices for regulated-market grade material, which are higher.

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Also on this molecule

Price history 2 yrs Recalls 3 Finished dose 6 Contract mfrs 2

By country

India 17 China 6

Export price by year

Year Median Exporters
2024 $19242.72 7
2023 $19298.36 22

US dollars per kilogram, customs export unit values.