Molecules / Fexofenadine

Fexofenadine API manufacturers

CAS 83799-24-0 ATC R06AX26 · Antihistamines Updated 9 July 2026
36
manufacturers with an active filing 13 of them hold a US DMF or a CEP
$103.00
median export price per kg $64.60 to $148.00 · 48 exporters · 2025
10
shortage records on file across 4 countries
552
finished-dose makers across 47 regulators
Showing 20 of 36 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

03

Virupaksha Organics

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

Holds 2 active US DMFs and one valid CEP for fexofenadine, filing since 2009. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

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

Morepen Laboratories

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

Holds one active US DMF and one valid CEP for fexofenadine, filing since 2016. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2023 · NAI
GMP recognised in
2 markets
05

Hetero

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

Holds 2 active US DMFs for fexofenadine, filing since 2011. 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
06

Vasudha Pharma Chem

India
Makes the API

Holds 2 active US DMFs for fexofenadine, filing since 2015. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Granules India

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

Holds 2 active US DMFs for fexofenadine, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
7 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 fexofenadine, filing since 2015. 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

Sanofi

France
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for fexofenadine. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 40 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
40 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
10

Chemeca Drugs

India
Makes the API

Holds one active US DMF for fexofenadine, filing since 2021. Its 2023 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Euroapi France

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

Holds one valid CEP for fexofenadine, filing since 2021. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2021 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
View profile
12

Dipharma Francis

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

Holds 2 active US DMFs for fexofenadine, filing since 2014. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 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
13

Jubilant Biosys

India
Makes the API

Holds 2 active US DMFs for fexofenadine, filing since 2013. 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
14

Matrix Pharmacorp

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

Holds one active US DMF for fexofenadine, filing since 2008. 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
15

Ind-Swift Laboratories

India
Makes the API

Registered with SFDA (Saudi Arabia) for fexofenadine. Its GMP is recognised in 3 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
3 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
16

Meyer Bpc Joint Venture

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for fexofenadine. 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
17

Imexpharm

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for fexofenadine. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
18

Công ty cổ phần dược phẩm Boston Việt Nam

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for fexofenadine. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
19

Ampharco

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for fexofenadine. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
20

Cty Tnhh Dược Phẩm Usa-Nic

Vietnam
Makes the API

Registered with DAV (Vietnam) for fexofenadine.

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

Contract manufacturers (9)

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
2025 $103.00 48
2024 $78.00 71
2023 $106.16 81
2022 $118.43 57

US dollars per kilogram, customs export unit values.