Molecules / Loperamide

Loperamide API manufacturers

CAS 53179-11-6 ATC A07DA03 Updated 9 July 2026
14
manufacturers with an active filing 6 of them hold a US DMF or a CEP
$325.00
median export price per kg $203.53 to $554.68 · 28 exporters · 2025
19
shortage records on file across 6 countries
843
finished-dose makers across 49 regulators
Showing 14 of 14 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Janssen Pharmaceutica

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

Holds one valid CEP for loperamide, filing since 2019. Its GMP is recognised in 7 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
7 markets
How this listing is sourced EDQM certificate database
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03

PMC Isochem

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

Holds 3 active US DMFs for loperamide, filing since 1988. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
3 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
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04

Vasudha Pharma Chem

India
Makes the API

Holds 2 active US DMFs for loperamide, filing since 2013. 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
05

Vamsi Labs

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

Holds 2 active US DMFs for loperamide, filing since 2025. Its 2018 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Lake Chemicals

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

Holds one valid CEP for loperamide, filing since 2025. 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
07

Imexpharm

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for loperamide. 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
08

Boston

Vietnam
Makes the API

Registered with DAV (Vietnam) for loperamide. 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

Công Ty TNHH Dược Phẩm Hạnh Thái

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for loperamide. 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

Registered with SFDA (Saudi Arabia) for loperamide. 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

Janssen Pharmaceutical

Belgium
Makes the API

Registered with SFDA (Saudi Arabia) for loperamide.

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
12

Agimexpharm Pharmaceutical

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for loperamide. 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

Registered with DAV (Vietnam) for loperamide. 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

Registered with DAV (Vietnam) for loperamide. 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

Contract manufacturers (2)

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.

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By country

Export price by year

Year Median Exporters
2025 $325.00 28
2024 $265.00 44
2023 $290.07 37
2022 $252.07 22

US dollars per kilogram, customs export unit values.