Molecules / Histidine

Histidine API manufacturers

CAS 71-00-1 Updated 9 July 2026
4
manufacturers with an active filing 4 of them hold a US DMF or a CEP
1
shortage records on file across 1 countries
351
finished-dose makers across 16 regulators
Showing 4 of 4 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

AMINO

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

Holds one active US DMF and one valid CEP for histidine, filing since 2022. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
2 markets
03

Kyowa Hakko Bio

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

Holds 2 valid CEPs for histidine, filing since 2022. Its 2024 FDA inspection closed as NAI.

US DMF
None on file
CEP
2 valid
Last FDA inspection
2024 · NAI
GMP recognised in
Not established

1 more manufacturer holds filings for histidine

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

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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

Who makes histidine?

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

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