Molecules / Isosulfan Blue

Isosulfan Blue API manufacturers

CAS 748080-29-7 Updated 9 July 2026
7
manufacturers with an active filing 7 of them hold a US DMF or a CEP
9
finished-dose makers across 1 regulators
Showing 7 of 7 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

MSN Laboratories

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

Holds one active US DMF for isosulfan blue, filing since 2020. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Dishman Carbogen Amcis

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

Holds one active US DMF for isosulfan blue, filing since 2016. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Biophore India Pharmaceuticals

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

Holds one active US DMF for isosulfan blue, filing since 2015. 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
04

Apitoria Pharma

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

Holds one active US DMF for isosulfan blue, filing since 2013. 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

Mylan Dublin

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

Its GMP is recognised in 4 markets.

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

Suven Pharmaceuticals

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

Holds 2 active US DMFs for isosulfan blue, filing since 2022. Its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Agno Pharma Usa

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

Holds one active US DMF for isosulfan blue, filing since 2020.

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

4 more manufacturers hold filings for isosulfan blue

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

Apitoria PharmaMylan DublinSuven PharmaceuticalsAgno Pharma Usa
Open the full list with a free account

Finished-dose makers (3)

Viatris United States Fresenius Kabi Ab Sweden Somerset Therapeutics India

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

Finished dose 3 Contract mfrs 0

By country

India 7