Molecules / Indocyanine Green

Indocyanine Green API manufacturers

CAS 3599-32-4 ATC V04CX01 Updated 9 July 2026
5
manufacturers with an active filing 4 of them hold a US DMF or a CEP
3
shortage records on file across 2 countries
40
finished-dose makers across 16 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Biophore India Pharmaceuticals

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

Holds one active US DMF for indocyanine green, filing since 2021. 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
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02

Nantong Jinghua Pharmaceutical

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

Holds one active US DMF for indocyanine green, filing since 2024. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

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

Icrom

Italy
Makes the API

Holds one active US DMF for indocyanine green, filing since 2023. 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
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04

Apicore

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

Holds one active US DMF for indocyanine green, filing since 2024.

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
05

Jsc Organica

Russia
Makes the API

Registered with SFDA (Saudi Arabia) for indocyanine green.

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
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2 more manufacturers hold filings for indocyanine green

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

ApicoreJsc Organica
Open the full list with a free account

Finished-dose makers (3)

Renew Pharmaceuticals Ireland Daiichi Sankyo Europe Germany Patheon France S.A.S France

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

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Also on this molecule

Shortages 3 Recalls 1 Finished dose 3 Contract mfrs 0