Molecules / Omeprazole

Omeprazole API manufacturers

CAS 73590-58-6 ATC A02BC01 · Proton pump inhibitors Updated 9 July 2026
44
manufacturers with an active filing 31 of them hold a US DMF or a CEP
$13.35
median export price per kg $7.45 to $60.00 · 168 exporters · 2025
304
shortage records on file across 8 countries
2,024
finished-dose makers across 56 regulators
Showing 20 of 44 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Lee Pharma

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

Holds one active US DMF and one valid CEP for omeprazole, filing since 2023. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
6 markets
02

Cipla

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

Holds 2 active US DMFs and 12 valid CEPs for omeprazole, filing since 1998. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
2 active
CEP
12 valid
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
04

Astrazeneca Ab

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

Holds 2 active US DMFs and one valid CEP for omeprazole, filing since 1997. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 37 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
37 markets
06

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 omeprazole, filing since 2017. 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
07

Natco Pharma

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

Holds 2 active US DMFs and one valid CEP for omeprazole, filing since 2008. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
15 markets
10

Nosch Labs

India
Makes the APIFinished dose

Holds one valid CEP for omeprazole, filing since 2025. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
6 markets
How this listing is sourced EDQM certificate database
View profile
11

Hetero

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

Holds 6 active US DMFs for omeprazole, filing since 2000. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
6 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Teva

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

Holds one valid CEP for omeprazole, filing since 2013. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 8 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · NAI
GMP recognised in
8 markets
How this listing is sourced EDQM certificate database
View profile
13

Lupin

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

Holds one active US DMF for omeprazole, filing since 2008. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

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

Everest Organics

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

Holds 8 active US DMFs for omeprazole, filing since 2015. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
8 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
15

Unión Químico Farmacéutica

Spain
Makes the APIFinished dose

Holds one active US DMF for omeprazole, filing since 2004. 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
16

Alivus Life Sciences

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

Holds 2 active US DMFs for omeprazole, filing since 2015. 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
17

Raks Pharma

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

Holds 2 active US DMFs for omeprazole, filing since 2013. Its 2025 FDA inspection closed as NAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
18

Wavelength Enterprises

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

Holds 4 active US DMFs for omeprazole, filing since 2011. Its 2022 FDA inspection closed as NAI.

US DMF
4 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
19

Esteve Química

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

Holds one active US DMF for omeprazole, filing since 1995. Its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
20

Apitoria Pharma

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

Holds 2 active US DMFs and 3 valid CEPs for omeprazole, filing since 2007. Its 2025 FDA inspection closed as VAI.

US DMF
2 active
CEP
3 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

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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By country

Export price by year

Year Median Exporters
2026 YTD $8.91 64
2025 $13.35 168
2024 $16.00 118
2023 $12.21 160

US dollars per kilogram, customs export unit values.