Molecules / Esomperazole

Esomperazole API manufacturers

Updated 9 July 2026
5
manufacturers with an active filing 0 of them hold a US DMF or a CEP
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hetero

India
Makes the API

Registered with SFDA (Saudi Arabia) for esomperazole. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
6 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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02

Lek Pharmaceuticals D.D

Slovenia
Makes the API

Registered with SFDA (Saudi Arabia) for esomperazole. Its GMP is recognised in 13 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
13 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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03

Cipla

India
Makes the API

Registered with SFDA (Saudi Arabia) for esomperazole. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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04

Krka

Slovenia
Makes the API

Registered with SFDA (Saudi Arabia) for esomperazole. Its GMP is recognised in 9 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
9 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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05

Minakem Dunkerque Production

France
Makes the API

Registered with SFDA (Saudi Arabia) for esomperazole. Its 2021 FDA inspection closed as VAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2021 · VAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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2 more manufacturers hold filings for esomperazole

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

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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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