Molecules / Isradipine

Isradipine API manufacturers

CAS 75695-93-1 ATC C08CA03 · Dihydropyridine calcium channel blockers Updated 9 July 2026
6
manufacturers with an active filing 6 of them hold a US DMF or a CEP
23
finished-dose makers across 13 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Solara Active Pharma Sciences

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

Holds one active US DMF for isradipine, filing since 2003. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Sterling Wisconsin

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

Holds one active US DMF for isradipine, filing since 2003. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
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
03

Quimica Sintetica

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

Holds one active US DMF for isradipine, filing since 2004. Its 2023 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Magle Chemoswed

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

Holds one valid CEP for isradipine, filing since 2023. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
05

Yangzhou Pharmaceutical

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

Holds one active US DMF for isradipine, filing since 2004. Its GMP is recognised in 1 market.

US DMF
1 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
06

Chemoswed Ab

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

Holds one active US DMF for isradipine, 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

3 more manufacturers hold filings for isradipine

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

Magle ChemoswedYangzhou PharmaceuticalChemoswed Ab
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Finished-dose makers (7)

Elite Laboratories United States Gsk Vaccines United Kingdom Daiichi Sankyo Europe Germany Italfarmaco Italy Casen Recordati, S.L Spain Smithkline Beecham United Kingdom Laboratorio Farmaceutico S.I.T. - Specialita Igienico Terapeutiche Italy

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 7 Contract mfrs 0