Molecules / Lansoprazole

Lansoprazole API manufacturers

CAS 103577-45-3 ATC A02BC03 · Proton pump inhibitors Updated 9 July 2026
29
manufacturers with an active filing 24 of them hold a US DMF or a CEP
$21.00
median export price per kg $14.27 to $50.00 · 64 exporters · 2025
161
shortage records on file across 6 countries
767
finished-dose makers across 51 regulators
Showing 20 of 29 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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

Holds one active US DMF and one valid CEP for lansoprazole, filing since 2008. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

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

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 lansoprazole, filing since 2013. 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
03

Zydus Lifesciences

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

Holds one active US DMF and one valid CEP for lansoprazole, filing since 2006. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
25 markets
05

Macleods Pharmaceuticals

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

Holds 2 active US DMFs for lansoprazole, filing since 2012. 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
06

Moehs

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

Holds one active US DMF and one valid CEP for lansoprazole, filing since 2004. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
07

Alkem Laboratories

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

Holds one active US DMF for lansoprazole, filing since 2011. Its GMP is recognised in 21 markets.

US DMF
1 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
08

Hetero

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

Holds 2 active US DMFs for lansoprazole, filing since 2007. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
2 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
09

Natco Pharma

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

Holds 2 active US DMFs for lansoprazole, filing since 2010. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
15 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Nosch Labs

India
Makes the APIFinished dose

Holds 2 valid CEPs for lansoprazole, filing since 2026. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
None on file
CEP
2 valid
Last FDA inspection
2024 · VAI
GMP recognised in
6 markets
11

Orchid Pharma

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

Holds one active US DMF for lansoprazole, filing since 2008. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

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

Cipla

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

Holds 4 valid CEPs for lansoprazole, filing since 2020. 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
13

Unión Químico Farmacéutica

Spain
Makes the API

Holds one active US DMF for lansoprazole, 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
14

Quimica Sintetica

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

Holds 2 active US DMFs for lansoprazole, filing since 2010. Its 2023 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Nifty Labs

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

Holds one valid CEP for lansoprazole, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
16

Olon

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

Holds one valid CEP for lansoprazole, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
How this listing is sourced EDQM certificate database
View profile
17

Matrix Pharmacorp

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

Holds one active US DMF for lansoprazole, filing since 2006. Its 2025 FDA inspection closed as VAI.

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

Jubilant Pharmova

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

Holds one active US DMF for lansoprazole, filing since 2009. Its GMP is recognised in 2 markets.

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

Chromo Laboratories India

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

Holds 2 active US DMFs for lansoprazole, filing since 2021. Its 2018 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
20

MSN Organics

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

Holds one active US DMF for lansoprazole, filing since 2025. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
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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Export price by year

Year Median Exporters
2026 YTD $26.88 27
2025 $21.00 64
2024 $22.00 55
2023 $21.80 66

US dollars per kilogram, customs export unit values.