Molecules / Esomeprazole

Esomeprazole API manufacturers

CAS 119141-88-7 ATC A02BC05 · Proton pump inhibitors Updated 9 July 2026
61
manufacturers with an active filing 39 of them hold a US DMF or a CEP
$57.00
median export price per kg $30.00 to $194.30 · 118 exporters · 2025
190
shortage records on file across 5 countries
1,389
finished-dose makers across 54 regulators
Showing 20 of 61 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

05

Granules India

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

Holds 4 active US DMFs and 2 valid CEPs for esomeprazole, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
4 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
7 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
06

Zydus Lifesciences

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 esomeprazole, filing since 2008. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

US DMF
3 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
07

Alivus Life Sciences

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

Holds 8 active US DMFs and one valid CEP for esomeprazole, filing since 2007. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
8 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
08

Hetero

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

Holds 6 active US DMFs for esomeprazole, filing since 2020. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
6 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
11

Torrent Pharmaceuticals

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

Holds 2 active US DMFs for esomeprazole, filing since 2009. Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 20 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2026 · NAI
GMP recognised in
20 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Macleods Pharmaceuticals

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

Holds 2 active US DMFs for esomeprazole, filing since 2014. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Alkem Laboratories

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

Holds 2 active US DMFs for esomeprazole, filing since 2014. Its GMP is recognised in 21 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
21 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
16

Shandong New Time Pharmaceutical

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

Holds one active US DMF for esomeprazole, filing since 2021. 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
17

Unión Químico Farmacéutica

Spain
Makes the API

Holds one active US DMF for esomeprazole, filing since 2016. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
18

Everest Organics

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

Holds 2 active US DMFs for esomeprazole, filing since 2018. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
19

Hainan Poly Pharm

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

Holds one active US DMF for esomeprazole, filing since 2020. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
20

Glenmark Pharmaceuticals s.r.o

Czech Republic
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for esomeprazole. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 40 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
40 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

58 more manufacturers hold filings for esomeprazole

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

CiplaGranules IndiaZydus LifesciencesAlivus Life SciencesHeteroSrini PharmaceuticalsShouguang Fukang PharmaceuticalTorrent PharmaceuticalsMacleods PharmaceuticalsNosch LabsShijiazhuang Lonzeal PharmaceuticalsAlkem LaboratoriesShandong New Time PharmaceuticalUnión Químico FarmacéuticaEverest OrganicsHainan Poly PharmGlenmark Pharmaceuticals s.r.o
Open the full list with a free account

Contract manufacturers (20)

Neuland Laboratories India Torrent Pharmaceuticals India Mac Chem Products India India Ethypharm France Metrochem API India Ciron Drugs & Pharmaceuticals India Finecure pharmaceuticals India Kopran India Anfarm Hellas Greece Montage Laboratories India Vem Ilac Sanayi Ve Ticaret A S Turkey Inist St South Korea Sainor Laboratories India Athena Pharmaceutiques Sas France Grupo Azevedos Portugal Jiangsu Zhongbang Pharmaceutical China KAISHA LIFESCIENCES India Nifty Labs P India Uquifa S A U Spain Yangtze River Pharmaceutical Group China

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

Finished-dose makers (122)

Viatris United States Astrazeneca Ab Sweden Astrazeneca Pharmaceuticals Lp United States Allegiant Health United States Biocon India Gland Pharma India Pharmascience Canada AstraZeneca UK United Kingdom Zentiva, k.s Czech Republic Haleon Ireland Dungarvan Ireland Ethypharm France Sandoz Switzerland Ajanta Pharma India Marksans Pharma India Teva Israel Eurofarma Laboratorios Brazil Towa Pharmaceutical Europe, S.L Spain Aspiro Pharma India Grünenthal Germany Micro Labs India

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.

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Also on this molecule

Price history 4 yrs Shortages 190 Recalls 19 Finished dose 122 Contract mfrs 20

By country

India 25 China 8

Export price by year

Year Median Exporters
2026 YTD $29.21 30
2025 $57.00 118
2024 $77.50 103
2023 $100.00 148

US dollars per kilogram, customs export unit values.