Molecules / Cetirizine

Cetirizine API manufacturers

CAS 83881-51-0 ATC R06AE07 Updated 9 July 2026
33
manufacturers with an active filing 16 of them hold a US DMF or a CEP
$90.90
median export price per kg $47.83 to $185.00 · 97 exporters · 2025
42
shortage records on file across 6 countries
1,171
finished-dose makers across 47 regulators
Showing 20 of 33 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Ipca Laboratories

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

Holds one active US DMF and 2 valid CEPs for cetirizine, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
19 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
03

Cipla

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

Holds one active US DMF and 4 valid CEPs for cetirizine, filing since 2000. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
1 active
CEP
4 valid
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
04

Granules India

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

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

US DMF
2 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
7 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
06

Ucb Pharma

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

Holds 2 active US DMFs for cetirizine, filing since 1987. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 28 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
28 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Wavelength Enterprises

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

Holds 8 active US DMFs for cetirizine, filing since 2002. Its 2022 FDA inspection closed as NAI.

US DMF
8 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Glochem Industries

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

Holds 2 active US DMFs for cetirizine, filing since 2006. Its 2024 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
10

COSMA

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

Holds 2 active US DMFs for cetirizine, filing since 2007. 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
11

Supriya Lifescience

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

Holds 2 active US DMFs for cetirizine, filing since 2024. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Orbion Pharmaceuticals

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

Holds one active US DMF for cetirizine, filing since 2007.

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
13

Arevipharma

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

Holds one valid CEP for cetirizine, filing since 2022. 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
14

Jubilant Biosys

India
Makes the API

Holds 2 active US DMFs for cetirizine, filing since 2007. 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
15

Matrix Pharmacorp

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

Holds one active US DMF for cetirizine, filing since 2004. 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
16

Imexpharm

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for cetirizine. 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
17

Sanofi

Egypt
Makes the APIFinished dose

Registered with DAV (Vietnam) for cetirizine. Its GMP is recognised in 6 markets.

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

Công Ty TNHH Dược Phẩm Hạnh Thái

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for cetirizine. 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
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for cetirizine, filing since 2008. Its 2024 FDA inspection closed as OAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · OAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
20

Registered with DAV (Vietnam) for cetirizine. 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

30 more manufacturers hold filings for cetirizine

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

Granules IndiaSolara Active Pharma SciencesUcb PharmaPraveen LaboratoriesWavelength EnterprisesGlochem IndustriesCOSMASupriya LifescienceOrbion PharmaceuticalsArevipharmaJubilant BiosysMatrix PharmacorpImexpharmSanofiCông Ty TNHH Dược Phẩm Hạnh TháiCalyx Chemicals and PharmaceuticalsCông ty Liên doanh dược phẩm Mebiphar - Austrapharm
Open the full list with a free account

Contract manufacturers (11)

Granules India India Metrochem API India Praveen Laboratories India Unison Pharmaceuticals India Corona Remedies India Titan Laboratories India Hunan Jiudian Hongyang Pharmaceutical China Santa Farma Ílaç San Turkey Athena Pharmaceutiques Sas France Wavelength Pharmaceuticals Israel Yangtze River Pharmaceutical Group China

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

Finished-dose makers (114)

Sandoz Switzerland Amneal United States Glenmark Pharmaceuticals s.r.o Czech Republic Allegiant Health United States Kenvue Brands United States Natco Pharma India Ohm Laboratories United States PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma United States Padagis Israel Israel Pharmascience Canada Zentiva, k.s Czech Republic Apotex Canada Cadila Pharmaceuticals India Bajaj Medical United States Contract Pharmacal United States Teva Israel Torrent Pharmaceuticals India Viatris United States Micro Labs India Square Pharmaceuticals Bangladesh

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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Also on this molecule

Price history 4 yrs Shortages 42 Recalls 15 Finished dose 114 Contract mfrs 11

By country

India 21

Export price by year

Year Median Exporters
2026 YTD $101.41 40
2025 $90.90 97
2024 $97.00 86
2023 $98.00 93

US dollars per kilogram, customs export unit values.