Molecules / Imatinib Mesilate

Imatinib Mesilate API manufacturers

Updated 9 July 2026
14
manufacturers with an active filing 12 of them hold a US DMF or a CEP
14
shortage records on file across 2 countries
48
finished-dose makers across 11 regulators
Showing 14 of 14 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Laurus Labs

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

Holds 2 valid CEPs for imatinib mesilate, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
None on file
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
13 markets
How this listing is sourced EDQM certificate database
EDQM certificate database
View profile
03

Synthimed Labs

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

Holds one valid CEP for imatinib mesilate, filing since 2024. Its 2020 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2020 · NAI
GMP recognised in
15 markets
How this listing is sourced EDQM certificate database
View profile
04

MSN Laboratories

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

Holds one valid CEP for imatinib mesilate, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
How this listing is sourced EDQM certificate database
View profile
05

Cipla

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

Holds 4 valid CEPs for imatinib mesilate, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
None on file
CEP
4 valid
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced EDQM certificate database
View profile
06

Natco Pharma

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

Holds one valid CEP for imatinib mesilate, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
15 markets
How this listing is sourced EDQM certificate database
View profile
07

Shilpa Pharma Lifesciences

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

Holds one valid CEP for imatinib mesilate, filing since 2022. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
10
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for imatinib mesilate, filing since 2023. Its GMP is recognised in 3 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
3 markets
How this listing is sourced EDQM certificate database
View profile
11

Zhejiang Ausun Pharmaceutical

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

Holds one valid CEP for imatinib mesilate, filing since 2025.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
12

zhejiang jiuzhou pharmaceutical

China
Makes the API

Registered with SFDA (Saudi Arabia) for imatinib mesilate. Its 2024 FDA inspection closed as NAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
13

Apitoria Pharma

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

Holds one valid CEP for imatinib mesilate, filing since 2025.

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

Acebright India Pharma

India
Makes the API

Registered with SFDA (Saudi Arabia) for imatinib mesilate.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

11 more manufacturers hold filings for imatinib mesilate

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

MSN LaboratoriesCiplaNatco PharmaShilpa Pharma LifesciencesShandong Anxin PharmaceuticalCdymax (India) PharmaDEVA HOLDİNG A.Ş. (2020/3) (Hammadde)Zhejiang Ausun Pharmaceuticalzhejiang jiuzhou pharmaceuticalApitoria PharmaAcebright India Pharma
Open the full list with a free account

Finished-dose makers (13)

Apotex Canada Fresenius Kabi Ab Sweden Zentiva, k.s Czech Republic Sandoz Switzerland Zydus Lifesciences India Denk Pharma GmbH Germany Remedica Cyprus Globela Pharma India Ferron Par Pharmaceuticals Indonesia Jazeera Pharmaceutical Industries Saudi Arabia Novartis Switzerland Saudi Arabian Japanese Pharmaceutical Saudi Arabia Teva Israel

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 14 Finished dose 13 Contract mfrs 0

By country

India 17 China 6