Molecules / Omeprazole / India

Omeprazole API manufacturers in India

CAS 73590-58-6 ATC A02BC01 Updated 9 July 2026
25
India-based manufacturers with an active filing of 44 worldwide
$13.35
median export price per kg, all origins $7.45 to $60.00 · 168 exporters · 2025
Showing 14 of 25 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based 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
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 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
06

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
08

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
09

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
10

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
11

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
12

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
13

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
14

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

11 more manufacturers in India hold filings for omeprazole

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

Open the full list with a free account

How this list is built

This page filters the worldwide Omeprazole manufacturer list to companies based in India. 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. Read the full method.

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