Molecules / Racecadotril

Racecadotril API manufacturers

CAS 81110-73-8 ATC A07XA04 Updated 9 July 2026
8
manufacturers with an active filing 4 of them hold a US DMF or a CEP
$275.00
median export price per kg $265.27 to $359.84 · 13 exporters · 2025
3
shortage records on file across 2 countries
149
finished-dose makers across 32 regulators
Showing 8 of 8 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Symed Labs

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

Holds one valid CEP for racecadotril, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
View profile
02
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for racecadotril, filing since 2023. Its 2016 FDA inspection closed as VAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2016 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
03

Shandong Boyuan Pharmaceutical

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

Holds one valid CEP for racecadotril, filing since 2024.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
04

Synkem Sas

France
Makes the API

Registered with SFDA (Saudi Arabia) for racecadotril.

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
05

Agimexpharm Pharmaceutical

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for racecadotril. 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
06

Ampharco

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for racecadotril. 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
07

Công ty: CP US Pharma USA

Vietnam
Makes the API

Registered with DAV (Vietnam) for racecadotril.

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
08

Tyche Industries

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

Holds one valid CEP for racecadotril, filing since 2024. 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

5 more manufacturers hold filings for racecadotril

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

Synkem SasAgimexpharm PharmaceuticalAmpharcoCông ty: CP US Pharma USATyche Industries
Open the full list with a free account

Contract manufacturers (2)

Xl Laboratories India Athena Pharmaceutiques Sas France

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

Finished-dose makers (35)

Sophartex France Zentiva, k.s Czech Republic Abbott Laboratories United States Laboratorios Arsal S A De C V El Salvador Corden Pharma Italy Macleods Pharmaceuticals India Ferrer Internacional Spain Xl Laboratories India Aché Laboratorios Farmacéuticos S. A Brazil Calox Venezuela Glaxosmithkline Brasil Ltda Brazil Imexpharm Vietnam Laboratorios Bagó Argentina Medifarma S A Peru Pharmacare Palestine Công ty TNHH US Pharma USA Vietnam Me Di Sun Vietnam Đạt vi Phú Vietnam 'Công ty cổ phần dược phẩm ME DI SUN Vietnam Aversi Rational Georgia

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 racecadotril 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.

Also on this molecule

Price history 4 yrs Shortages 3 Finished dose 35 Contract mfrs 2

Export price by year

Year Median Exporters
2025 $275.00 13
2024 $319.48 11
2023 $345.00 13
2022 $412.00 9

US dollars per kilogram, customs export unit values.