Molecules / Phentolamine

Phentolamine API manufacturers

CAS 50-60-2 ATC C04AB01 Updated 9 July 2026
5
manufacturers with an active filing 5 of them hold a US DMF or a CEP
3
shortage records on file across 1 countries
23
finished-dose makers across 8 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Jiangsu Lianhuan Pharmaceutical

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

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

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Matrix Pharmacorp

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

Holds 2 active US DMFs for phentolamine, filing since 2014. Its 2025 FDA inspection closed as VAI.

US DMF
2 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
03

Reliable Biopharmaceutical

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

Holds one active US DMF for phentolamine, filing since 1996. 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
04

Industriale Chimica

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

Holds one active US DMF for phentolamine, filing since 2003. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Apicore

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

Holds one active US DMF for phentolamine, 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

2 more manufacturers hold filings for phentolamine

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

Industriale ChimicaApicore
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Finished-dose makers (5)

HIKMA ITALIA Italy Viatris United States Novartis Switzerland Pharmascience Canada Natulab Laboratorio Brazil

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 113 Finished dose 5 Contract mfrs 0