Suppliers and packagers for generic pharmaceutical drug: DANTROLENE SODIUM

DANTROLENE SODIUM

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ph Health	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443	NDA	Endo USA, Inc.	42023-124-01	100 CAPSULE in 1 BOTTLE (42023-124-01)	2008-08-01
Ph Health	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443	NDA AUTHORIZED GENERIC	Endo USA, Inc.	49884-362-01	100 CAPSULE in 1 BOTTLE (49884-362-01)	2016-03-28
Ph Health	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443	NDA AUTHORIZED GENERIC	Endo USA, Inc.	49884-363-01	100 CAPSULE in 1 BOTTLE (49884-363-01)	2016-03-28
Ph Health	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443	NDA AUTHORIZED GENERIC	Endo USA, Inc.	49884-364-01	100 CAPSULE in 1 BOTTLE (49884-364-01)	2016-03-28

Suppliers and packagers for generic pharmaceutical drug: DANTROLENE SODIUM

Last updated: April 25, 2026

Who Supplies Dantrolene Sodium (API and Key Intermediates) to the Pharma Supply Chain?

Dantrolene sodium is supplied through a typical API-manufacturing supply chain: (1) API makers that sell dantrolene sodium (or dantrolene and convert/salt-form internally), (2) intermediate suppliers that produce the core chemical scaffolds, and (3) contract manufacturing organizations (CMOs) that package API into finished dosage forms for the branded or generic market. This answer lists supplier categories and the specific supplier identification approach that is used in high-stakes sourcing workflows for APIs, including how to map verified manufacturers to regulatory status in major markets.

Which supplier types provide dantrolene sodium?

1) API manufacturers (sell dantrolene sodium directly or via salt conversion)

API suppliers typically provide one of these supply states:

• Dantrolene sodium API (salt form) packed as API with CoA and full regulatory documentation.
• Dantrolene (free base) that is converted to dantrolene sodium under controlled salt-form steps at the manufacturer or at a downstream site.

In sourcing practice, the key question is whether the supplier can document salt form, polymorph (if applicable), and impurity profile to match the target pharmacopeial or registration specs.

2) Intermediate suppliers (sell upstream chemical building blocks)

Many API producers rely on external manufacture of one or more of the following categories of inputs:

• Aromatic building blocks for the dantrolene core
• Halogenated or functionalized intermediates
• Final-form synthesis intermediates controlled for residual catalysts and solvents

Intermediate supply matters because it determines impurity carryover and batch-to-batch consistency.

3) CMOs and dosage-form manufacturers (for product-level sourcing)

Where the buyer needs finished product rather than API, dosage-form CMOs supply:

• Tablets/capsules or sterile formulations (if applicable to market-specific product lines)
• Packaging and labeling under the buyer’s marketing authorization (for generics and contract brands)

How do procurement teams identify the actual legal suppliers for dantrolene sodium?

Regulatory ledgers that map to real-world suppliers

For API-grade sourcing, the most decision-relevant documents are those that tie a manufacturer site to a specific product and strength. Procurement teams typically cross-check:

• US FDA Orange Book listings for dantrolene sodium products to identify approved manufacturers tied to NDA/ANDA holders, then trace to API and manufacturing sites via:

  • Labeling
  • Facility registrations
  • NDA/ANDA chemistry sections (when accessible via public summaries and submissions)

• EU pharmacovigilance and manufacturing authorizations via:

  • National competent authority databases
  • EU GMP site listings where available

• China NMPA approvals for product listings and manufacturer registration status (when buying for China distribution)

Site-level verification

Even when a company is named as an API supplier, procurement teams validate:

• GMP compliance for the specific API category
• Traceability of starting materials and salt-form steps
• Impurity profile alignment (process-related and solvent residues)
• Stability data for the salt form

Who are the likely supplier candidates in practice? (Supplier categories, not unverified names)

Because “dantrolene sodium suppliers” is a high-risk search phrase with many listings that mix:

• finished product distributors,
• non-GMP chemical brokers,
• relabelers,
• and inaccurate API claims,

a complete and accurate supplier list must be tied to regulatory and verified manufacturing status. Without verified regulatory mapping, naming specific companies creates a high probability of misidentification.

What to demand from dantrolene sodium suppliers before PO? (Procurement checklist)

API supply package

• CoA for each batch
• Full specification sheet for dantrolene sodium (assay, related substances, water, residual solvents, heavy metals)
• Particle size and salt-form confirmation (when supplier can provide it)
• Traceability of synthesis route and salt conversion steps (if starting from dantrolene)

Quality and compliance

• Relevant GMP certificate(s) for the API manufacturing site(s)
• Current GMP status and inspection history (at least to the extent documented in onboarding)
• Validation package for analytical methods used to measure impurities and salt form

Commercial and technical

• Typical lead times, MOQ, and change-control policy
• Tech transfer package if the buyer is qualifying a new supplier
• Risk management dossier aligned to buyer’s QMS (change control and deviation summaries)

How does salt form sourcing affect procurement terms for dantrolene sodium?

Dantrolene sodium is a salt form; supply differs depending on whether the supplier:

• manufactures the sodium salt directly, or
• produces dantrolene free base then forms the sodium salt downstream.

This changes:

• impurity profile risk
• stability in storage conditions
• documentation requirements for salt form verification

Procurement teams generally require explicit documentation stating:

• salt formation method,
• control strategy for residual solvents and inorganic impurities,
• and analytical confirmation steps for dantrolene sodium identity.

Key Takeaways

• Dantrolene sodium supply comes through API makers, intermediate suppliers, and in some cases CMOs for finished dosage forms.
• The supplier list that matters for sourcing must be tied to regulatory and site-level GMP status, not marketplace claims.
• Salt form sourcing (direct sodium salt vs sodium salt formed from free base) drives specification, impurity, and stability expectations.
• Your sourcing decision should be anchored on CoA/specs, impurity control, GMP documentation, and traceability of the salt-form step.

FAQs

1) Is dantrolene sodium supplied as API only, or also as finished product?

It is supplied as API for manufacturers and also as finished dosage forms via dosage-form CMOs for marketed products, depending on market needs and buyer strategy.

2) Do suppliers always produce the sodium salt directly?

Not always. Some suppliers sell dantrolene (free base) and perform salt conversion to dantrolene sodium under controlled steps, which changes documentation and verification requirements.

3) What documentation should procurement require for API?

At minimum: CoA per batch, full API specifications, impurity and solvent/residue controls, GMP certificates for the manufacturing site, and confirmation of the salt form and identity testing methods.

4) Where do buyers find the most reliable evidence of legitimate manufacturers?

Regulatory listings tied to marketing authorizations (US Orange Book, EU national/competent authority pathways, and GMP site authorizations) and site-level GMP verification.

5) What is the biggest technical risk in qualifying a new dantrolene sodium supplier?

Salt form consistency and impurity profile alignment driven by the supplier’s synthetic route and salt conversion control strategy.

Sources (APA) [1] FDA. (n.d.). Drugs@FDA: FDA Approved Drug Products. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
[3] European Medicines Agency. (n.d.). EU GMP and related guidance (GMP compliance and inspections). European Medicines Agency. https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice