Molecules / Dantrolene

Dantrolene API manufacturers

CAS 7261-97-4 ATC M03CA01 Updated 9 July 2026
6
manufacturers with an active filing 6 of them hold a US DMF or a CEP
14
shortage records on file across 2 countries
36
finished-dose makers across 17 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Gland Pharma

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

Holds one active US DMF for dantrolene, filing since 2024. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
1 active
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
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02

HAS Healthcare Advanced Synthesis

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

Holds 2 active US DMFs for dantrolene, filing since 2006. Its 2025 FDA inspection closed as NAI.

US DMF
2 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
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03

Biophore India Pharmaceuticals

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

Holds one active US DMF for dantrolene, filing since 2019. 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

ScinoPharm Taiwan

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

Holds one active US DMF for dantrolene, filing since 2002. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dantrolene, filing since 2000. 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

Veranova Lp

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

Holds one active US DMF for dantrolene, filing since 2007.

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 dantrolene

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

ScinoPharm TaiwanJinan Jinda Pharmaceutical ChemistryVeranova Lp
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Contract manufacturers (1)

Olon Italy

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (5)

HIKMA ITALIA Italy Norgine Healthcare United Kingdom JHP Pharmaceuticals United States Pfizer Brasil Ltda Brazil Par Health USA United States

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

Who makes dantrolene?

Ask Fred which manufacturers are on record for dantrolene and what filings they hold.

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Also on this molecule

Shortages 14 Recalls 3 Finished dose 5 Contract mfrs 1