Molecules / Fluorescein

Fluorescein API manufacturers

CAS 2321-07-5 ATC S01JA01 Updated 9 July 2026
6
manufacturers with an active filing 6 of them hold a US DMF or a CEP
17
shortage records on file across 5 countries
108
finished-dose makers across 29 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Icrom

Italy
Makes the API

Holds 2 active US DMFs and one valid CEP for fluorescein, filing since 2015. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
02

Biophore India Pharmaceuticals

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

Holds one active US DMF for fluorescein, filing since 2023. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Delmar Chemicals

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

Holds 2 active US DMFs for fluorescein, filing since 2005. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Apicore Pharmaceuticals

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

Holds one active US DMF for fluorescein, filing since 2024. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Abbey Color

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

Holds one active US DMF for fluorescein, filing since 2006.

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
06

Macsen Drugs

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

Holds one active US DMF for fluorescein, filing since 2023.

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

3 more manufacturers hold filings for fluorescein

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 (1)

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 fluorescein?

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

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