Molecules / Azelastine

Azelastine API manufacturers

CAS 58581-89-8 ATC R01AC03 Updated 9 July 2026
15
manufacturers with an active filing 11 of them hold a US DMF or a CEP
$6375.28
median export price per kg $5551.02 to $10161.21 · 8 exporters · 2024
5
shortage records on file across 4 countries
377
finished-dose makers across 38 regulators
Showing 15 of 15 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

MSN 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 azelastine, filing since 2011. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
02

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 azelastine, filing since 2009. 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
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
04

“Gedeon Richter”

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

Holds one active US DMF for azelastine, filing since 2001. Its GMP is recognised in 28 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
28 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Urquima

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

Holds one active US DMF for azelastine, filing since 2007. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2021 · VAI
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Daito

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

Holds one active US DMF for azelastine, filing since 2005. 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
07

Esteve Química

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

Holds one active US DMF for azelastine, filing since 2009. 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
08

Korea United Pharmaceuticals

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

Holds one active US DMF for azelastine, filing since 2010. Its GMP is recognised in 5 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
5 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Coral Drugs

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

Holds 2 active US DMFs for azelastine, filing since 2021. Its 2019 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Zhejiang Lepu Pharmaceutical

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

Holds one active US DMF for azelastine, filing since 2022. 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
11

Curia

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

Holds one active US DMF for azelastine, filing since 2006.

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
12

Evonik Technochemie

Germany
Makes the API

Registered with SFDA (Saudi Arabia) for azelastine.

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
13

Lifesciences and Pharma Telangana

India
Makes the API

Registered with SFDA (Saudi Arabia) for azelastine.

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
14

Công ty Cổ phần Dược phẩm CPC1 Hà Nội

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for azelastine. 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
15

Registered with DAV (Vietnam) for azelastine. 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

12 more manufacturers hold filings for azelastine

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

“Gedeon Richter”UrquimaDaitoEsteve QuímicaKorea United PharmaceuticalsCoral DrugsZhejiang Lepu PharmaceuticalCuriaEvonik TechnochemieLifesciences and Pharma TelanganaCông ty Cổ phần Dược phẩm CPC1 Hà NộiCông ty Cổ phần Dược phẩm Gia Nguyễn
Open the full list with a free account

Contract manufacturers (3)

Coral Drugs India Lgm Pharma United States Biodeal Pharmasuticals India

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (46)

Viatris United States Apotex Canada Amneal United States Sandoz Switzerland Alembic Pharmaceuticals India Allegiant Health United States Bayer S/A Brazil Zentiva, k.s Czech Republic Glenmark Pharmaceuticals s.r.o Czech Republic HIKMA ITALIA Italy Novo Nordisk Production Sas France Ursapharm Arzneimittel Germany Laboratorios Salvat S A Spain Amneal Pharmaceuticals NY United States Cipla India Epic Pharma United States Micro Labs India Padagis Israel Israel Laboratorios Cinfa S A Spain STADA Arzneimittel Germany

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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Also on this molecule

Price history 3 yrs Shortages 5 Recalls 4 Finished dose 46 Contract mfrs 3

By country

India 6

Sold in these combinations

Fluticasone Propionate + Azelastine 2 APIs

Fixed-dose combinations containing azelastine. Each page leads with the verified API makers of every component.

Export price by year

Year Median Exporters
2024 $6375.28 8
2023 $7274.73 6
2022 $7585.92 5

US dollars per kilogram, customs export unit values.