Molecules / Nilotinib

Nilotinib API manufacturers

CAS 641571-10-0 ATC L01XE08 Updated 9 July 2026
14
manufacturers with an active filing 13 of them hold a US DMF or a CEP
$4426.58
median export price per kg $3939.67 to $5915.07 · 10 exporters · 2024
8
shortage records on file across 5 countries
248
finished-dose makers across 48 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 APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 3 active US DMFs and one valid CEP for nilotinib, filing since 2015. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
3 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced EDQM certificate database
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 4 active US DMFs and one valid CEP for nilotinib, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
4 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
03

Hetero

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

Holds one active US DMF for nilotinib, filing since 2015. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

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

HIKMA ITALIA

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

Holds one active US DMF for nilotinib, filing since 2015. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 14 markets.

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

Teva

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

Holds one active US DMF for nilotinib, filing since 2020. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 42 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
42 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 nilotinib, filing since 2021. 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

Cipla

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

Holds one active US DMF for nilotinib, filing since 2022. 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
08

Granules India

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

Holds one active US DMF for nilotinib, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
1 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
09

Natco Pharma

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

Holds 2 active US DMFs for nilotinib, filing since 2022. 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
10

Sichuan Elixir Pharmaceutical

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

Holds one active US DMF for nilotinib, filing since 2024. Its GMP is recognised in 5 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
5 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Suzhou Lixin Pharmaceutical

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

Holds one active US DMF for nilotinib, filing since 2017. Its 2023 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Ravi Biolife

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

Holds one valid CEP for nilotinib, filing since 2026. Its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
View profile
14

Jiangsu Xidi Pharmaceuticals

China
Makes the API

Registered with SFDA (Saudi Arabia) for nilotinib. 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
View profile

11 more manufacturers hold filings for nilotinib

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

HIKMA ITALIATevaShilpa Pharma LifesciencesCiplaGranules IndiaNatco PharmaSichuan Elixir PharmaceuticalSuzhou Lixin PharmaceuticalShandong Lixin PharmaceuticalRavi BiolifeJiangsu Xidi Pharmaceuticals
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Finished-dose makers (19)

Apotex Canada Torrent Pharmaceuticals India Zentiva, k.s Czech Republic Novartis Switzerland Viatris United States STADA Arzneimittel Germany Lek Pharmaceuticals D.D Slovenia Novartis Farmacéutica, S. A Spain Anabiosis India Laboratorio Elea Phoenix Argentina Laboratorios Ima S.A.I.C Argentina Laboratorio Eczane Pharma Argentina Laboratorio Stada S.L Spain Tuteur S A C I F I A Argentina Eg S P A Italy Juno Pharmaceuticals Canada Laboratorio Varifarma S A Argentina Novugen Oncology Sdn Bhd Malaysia The Arab Pharmaceutical Manufacturing Psc Jordan

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.

Who makes nilotinib?

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

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Also on this molecule

Price history 2 yrs Shortages 8 Recalls 2 Finished dose 19 Contract mfrs 0

By country

India 8

Export price by year

Year Median Exporters
2024 $4426.58 10
2023 $5884.85 10

US dollars per kilogram, customs export unit values.