Molecules / Rupatadine

Rupatadine API manufacturers

CAS 158876-82-5 ATC R06AX28 · Antihistamines Updated 9 July 2026
13
manufacturers with an active filing 8 of them hold a US DMF or a CEP
$808.09
median export price per kg $450.00 to $1300.00 · 15 exporters · 2025
1
shortage records on file across 1 countries
199
finished-dose makers across 30 regulators
Showing 13 of 13 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

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 rupatadine, filing since 2025. 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
02

Cadila Pharmaceuticals

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

Holds one valid CEP for rupatadine, filing since 2025. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
15 markets
How this listing is sourced EDQM certificate database
View profile
03

Hetero

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

Holds one valid CEP for rupatadine, filing since 2025. 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
04

FDC

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

Holds 3 valid CEPs for rupatadine, filing since 2024. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 16 markets.

US DMF
None on file
CEP
3 valid
Last FDA inspection
2023 · NAI
GMP recognised in
16 markets
How this listing is sourced EDQM certificate database
View profile
05

Vasudha Pharma Chem

India
Makes the API

Holds 2 active US DMFs for rupatadine, filing since 2023. 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
06

Urquima

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

Holds one active US DMF for rupatadine, filing since 2021. 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
07

Tagoor Laboratories

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

Holds one valid CEP for rupatadine, filing since 2026. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile

Registered with DAV (Vietnam) for rupatadine. 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
09

Meyer Bpc Joint Venture

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for rupatadine. 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
10

'Công ty cổ phần dược phẩm ME DI SUN

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for rupatadine. 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
11

Công ty cổ phần dược phẩm Boston Việt Nam

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for rupatadine. 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

Pharbaco

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for rupatadine. 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
13

Tyche Industries

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

Holds one valid CEP for rupatadine, filing since 2026. Its 2024 FDA inspection closed as OAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · OAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile

Contract manufacturers (3)

Morepen Laboratories India Santa Farma Ílaç San Turkey Yangtze River Pharmaceutical Group China

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

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.

Map rupatadine for your markets

Tell us which markets you need to file in. These suppliers come back tiered for those markets, with the price corridor and an RFI sheet.

Start for free
No sales call.

By country

Export price by year

Year Median Exporters
2025 $808.09 15
2024 $1000.00 17
2023 $1099.94 16
2022 $750.00 13

US dollars per kilogram, customs export unit values.