Molecules / Azilsartan Medoxomil

Azilsartan Medoxomil API manufacturers

CAS 863031-21-4 ATC C09CA09 · Angiotensin II receptor blockers Updated 9 July 2026
19
manufacturers with an active filing 18 of them hold a US DMF or a CEP
$1100.00
median export price per kg $700.00 to $2100.00 · 11 exporters · 2024
46
finished-dose makers across 21 regulators
Showing 19 of 19 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Lupin

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

Holds one active US DMF for azilsartan medoxomil, filing since 2019. 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
02

Alembic Pharmaceuticals

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

Holds one active US DMF for azilsartan medoxomil, filing since 2015. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

MSN Laboratories

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

Holds 2 active US DMFs for azilsartan medoxomil, filing since 2014. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Piramal Pharma

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

Holds one active US DMF for azilsartan medoxomil, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Alkem Laboratories

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

Holds one active US DMF for azilsartan medoxomil, filing since 2023. 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
06

Jiangxi Synergy Pharmaceutical

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

Holds 2 active US DMFs for azilsartan medoxomil, filing since 2024. 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
07

Reyoung Pharmaceuticals

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

Holds one active US DMF for azilsartan medoxomil, filing since 2024. Its GMP is recognised in 4 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Apitoria Pharma

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

Holds one active US DMF for azilsartan medoxomil, filing since 2020. 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
09

Honour Lab

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

Holds one active US DMF for azilsartan medoxomil, filing since 2017. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Hec Pharm

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

Holds one active US DMF for azilsartan medoxomil, filing since 2014. Its GMP is recognised in 4 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Jubilant Biosys

India
Makes the API

Holds 2 active US DMFs for azilsartan medoxomil, filing since 2015. Its 2022 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Linhai Tianyu Pharmaceutical

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

Holds 2 active US DMFs for azilsartan medoxomil, filing since 2024. 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
13

Chromo Laboratories India

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

Holds 2 active US DMFs for azilsartan medoxomil, filing since 2024. 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
14

Shandong Loncom Pharmaceutical

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

Holds one active US DMF for azilsartan medoxomil, filing since 2026. 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
17

Wuhan Rs Pharmaceuticals

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

Holds 2 active US DMFs for azilsartan medoxomil, filing since 2024.

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

Xuzhou Wanbang Jinqiao Pharma

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

Holds one active US DMF for azilsartan medoxomil, filing since 2025.

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

Takeda Pharmaceutical

Japan
Makes the API

Registered with SFDA (Saudi Arabia) for azilsartan medoxomil. Its GMP is recognised in 2 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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 2024. These are export values rather than contract prices for regulated-market grade material, which are higher.

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