Molecules / Isoprenaline

Isoprenaline API manufacturers

CAS 7683-59-2 ATC C01CA02 Updated 9 July 2026
12
manufacturers with an active filing 11 of them hold a US DMF or a CEP
7
shortage records on file across 1 countries
111
finished-dose makers across 20 regulators
Showing 12 of 12 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Harman Finochem

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

Holds one valid CEP for isoprenaline, filing since 2016. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
3 markets
02

Hospira

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

Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 41 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
41 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Micro Labs

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

Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 20 markets.

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

Gland Pharma

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

Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
19 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Deva Holding

Turkey
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Its GMP is recognised in 12 markets.

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

Biophore India Pharmaceuticals

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

Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
None on file
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
08

Apitoria Pharma

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

Its 2025 FDA inspection closed as VAI.

US DMF
None on file
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
09

Edmond Pharma

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

Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 5 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
5 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Sterling Wisconsin

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

Its 2024 FDA inspection closed as NAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Wuhan Wuyao Pharmaceutical

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

Holds one valid CEP for isoprenaline, filing since 2026. Its 2025 FDA inspection closed as VAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
12

Azico Biophore India

India
Makes the API

Registered with SFDA (Saudi Arabia) for isoprenaline. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

9 more manufacturers hold filings for isoprenaline

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

Open the full list with a free account

Contract manufacturers (1)

Shandong Shengyuan Pharmaceutical Co L China

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

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