Molecules / Cholic Acid

Cholic Acid API manufacturers

CAS 81-25-4 ATC A05AA03 Updated 9 July 2026
5
manufacturers with an active filing 5 of them hold a US DMF or a CEP
4
shortage records on file across 3 countries
24
finished-dose makers across 15 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

PharmaZell

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

Holds one active US DMF and one valid CEP for cholic acid, filing since 2023. Its 2022 FDA inspection closed as VAI.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
02

Dipharma Francis

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

Holds one active US DMF and one valid CEP for cholic acid, filing since 2015. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
03

New Zealand Pharmaceuticals

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

Holds one active US DMF for cholic acid, filing since 2013. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 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
04

ICE

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

Holds 2 valid CEPs for cholic acid, filing since 2024. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
2 valid
Last FDA inspection
2022 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
EDQM certificate database
View profile
05

Sthree Chemicals

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

Holds one active US DMF for cholic acid, filing since 2025.

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

2 more manufacturers hold filings for cholic acid

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

ICESthree Chemicals
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Finished-dose makers (3)

Norgine Healthcare United Kingdom «B. Braun Medical» Portugal Tuteur S A C I F I A Argentina

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

Who makes cholic acid?

Ask Fred which manufacturers are on record for cholic acid and what filings they hold.

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Also on this molecule

Shortages 4 Recalls 9 Finished dose 3 Contract mfrs 0