Molecules / Desloratadine

Desloratadine API manufacturers

CAS 100643-71-8 ATC R06AX27 · Antihistamines Updated 9 July 2026
26
manufacturers with an active filing 11 of them hold a US DMF or a CEP
$545.00
median export price per kg $372.96 to $800.00 · 58 exporters · 2025
9
shortage records on file across 4 countries
1,054
finished-dose makers across 51 regulators
Showing 20 of 26 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Cadila Pharmaceuticals

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 desloratadine, filing since 2007. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.

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

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 desloratadine, filing since 2006. 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
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
04

Morepen 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 desloratadine, filing since 2004. 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
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
05

Hetero

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

Holds one valid CEP for desloratadine, filing since 2026. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
How this listing is sourced EDQM certificate database
View profile
06

Lupin

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

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

Glenmark Pharmaceuticals s.r.o

Czech Republic
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for desloratadine. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 40 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
40 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
08

Cipla

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

Holds 4 valid CEPs for desloratadine, filing since 2021. 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
09

Zydus Lifesciences

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

Holds one valid CEP for desloratadine, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
25 markets
How this listing is sourced EDQM certificate database
View profile
10

Vasudha Pharma Chem

India
Makes the API

Holds 2 active US DMFs for desloratadine, filing since 2014. 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
11

Orbion Pharmaceuticals

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

Holds one active US DMF for desloratadine, 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

Matrix Pharmacorp

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

Holds one active US DMF for desloratadine, filing since 2007. 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
13

Ampharco

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for desloratadine. 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
14

Meyer Bpc Joint Venture

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for desloratadine. 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
15

Boston

Vietnam
Makes the API

Registered with DAV (Vietnam) for desloratadine. 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
16

Registered with SFDA (Saudi Arabia) for desloratadine.

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
17

Registered with SFDA (Saudi Arabia) for desloratadine.

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
18

'Công ty cổ phần dược phẩm ME DI SUN

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for desloratadine. 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

Agimexpharm Pharmaceutical

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for desloratadine. 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

23 more manufacturers hold filings for desloratadine

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

Morepen LaboratoriesHeteroLupinGlenmark Pharmaceuticals s.r.oCiplaZydus LifesciencesVasudha Pharma ChemOrbion PharmaceuticalsMatrix PharmacorpAmpharcoMeyer Bpc Joint VentureBostonArgan Company For Pharmaceutcal And MedicalMatrix (Mylan) Laboratories Ltd. (Unit-7)'Công ty cổ phần dược phẩm ME DI SUNAgimexpharm PharmaceuticalBinh Dinh Pharmaceutical And Medical Equipment Joint Stock Company Bidiphar
Open the full list with a free account

Contract manufacturers (8)

Divi's Laboratories India Morepen Laboratories India Unison Pharmaceuticals India Vem Ilac Sanayi Ve Ticaret A S Turkey All Chemistry United States Farmhispania Group Spain Inke Spain Laboratorios Basi Industria Farmaceuti Portugal

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

Finished-dose makers (203)

Zentiva, k.s Czech Republic Apotex Canada Viatris United States Sandoz Switzerland Ajanta Pharma India Bayer HealthCare United States Denk Pharma GmbH Germany Laboratorios Normon Spain Towa Pharmaceutical Europe, S.L Spain Bayer S/A Brazil Delta Pharma Pakistan Eurofarma Laboratorios Brazil Laboratorios Liomont, S.A. de C.V Mexico Sanofi France Square Pharmaceuticals Bangladesh Laboratorios Cinfa S A Spain Bayer Germany Bristol-Myers Squibb United States Cenexi Hsc France Gilead Sciences United States

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 9 Recalls 5 Finished dose 203 Contract mfrs 8

By country

India 12

Sold in these combinations

Desloratadine + Pseudoephedrine 2 APIs

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

Export price by year

Year Median Exporters
2026 YTD $477.28 20
2025 $545.00 58
2024 $630.00 51
2023 $600.00 47

US dollars per kilogram, customs export unit values.