Suppliers and packagers for generic pharmaceutical drug: sodium nitroprusside

sodium nitroprusside

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	209493	ANDA	Amneal Pharmaceuticals LLC	70121-1189-1	1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1189-1) / 2 mL in 1 VIAL, SINGLE-DOSE	2017-11-07
Be Pharms	SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	214971	ANDA	BE Pharmaceuticals Inc.	71839-120-01	1 VIAL in 1 CARTON (71839-120-01) / 2 mL in 1 VIAL	2021-07-12
Caplin	SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	211016	ANDA	Caplin Steriles Limited	65145-101-01	1 VIAL, SINGLE-DOSE in 1 CARTON (65145-101-01) / 2 mL in 1 VIAL, SINGLE-DOSE	2025-10-29

Suppliers and packagers for generic pharmaceutical drug: sodium nitroprusside

Last updated: May 24, 2026

Sodium Nitroprusside Suppliers: Who Manufactures, Distributes, and Competes in the US Market

Sodium nitroprusside is supplied in multiple geographies as a pharmaceutical-grade active ingredient and as reconstitutable/injectable products under different brand and license arrangements. The supplier landscape is shaped by small-API manufacturing capacity, tight quality systems for reactive inorganic actives, and limited FDA and compendial-grade availability in the US.

Who supplies sodium nitroprusside pharmaceutical ingredient and injection products?

Featured supplier categories

• API manufacturers (sodium nitroprusside as bulk active)
• US distributors/importers (handling GDUFA, customs, and chain-of-custody)
• Finished-dose product manufacturers (injectables or hospital-use vials when available under NDA/ANDA or compendial/labeler arrangements)

What typically exists in the market

• Sodium nitroprusside is often sold as:
  • Pharmaceutical-grade API for formulation under GMP by specialized chemical manufacturers.
  • Hospital/compounded supply through distributors when finished sterile product supply is intermittent.
• Availability in the US is commonly driven by:
  • Compliance capacity for sterile manufacturing (if finished vials are made domestically)
  • Ability to supply controlled, reactive inorganic material under GMP
  • Ability to support US regulatory filing needs (e.g., Drug Listing/registration, import documentation)

Which companies are major sodium nitroprusside suppliers by geography?

EU/UK manufacturers (typical pattern)

• Specialty inorganic API producers and chemical-pharma manufacturers supply bulk sodium nitroprusside for downstream sterile and non-sterile uses.
• Many EU vendors sell under drug master file supporting documentation to qualified customers, rather than as fully finished US-labeled injectables.

US supply pattern

• US often relies on:
  • Importer-distributors sourcing API abroad and supplying hospitals/compounding pharmacies
  • Finished-dose sterile product manufacturers when there is continuity of supply
• US channel availability usually changes with:
  • Cold-chain or light sensitivity handling requirements (as applicable)
  • Lot acceptance testing constraints
  • Production interruptions due to limited upstream synthesis capacity

Asia supply pattern

• Several chemical manufacturers in China and India supply bulk sodium nitroprusside, often with:
  • Competitive pricing
  • Variable documentation packages
  • Strong dependence on customer qualification

Commercial implication

• In practice, many buyers qualify 2 to 4 sources (API and/or finished vials) because single-source risk is material for reactive inorganic actives.

How to identify sodium nitroprusside suppliers for a US tender or hospital procurement?

Procurement-grade qualification checklist (what suppliers must provide)

• Certificate of Analysis and batch traceability for each lot
• GMP manufacturing statements or DMF/ASMF linkages where applicable
• Sterility assurance documentation if supplying injectable presentations
• Stability and handling documentation aligned to label storage (light sensitivity and aqueous stability constraints, where applicable)
• Regulatory documentation for US distribution (registration/listing support; importer of record capability)

Sourcing structure that works

• For finished injectable requirements: qualify the finished-dose manufacturer (not only the distributor).
• For formulation requirements: qualify the API manufacturer and ensure the distributor provides matching CoA and compliance statements per lot.

Are there FDA-approved sodium nitroprusside injection products and who makes them?

For sodium nitroprusside, supplier identification through regulatory databases hinges on whether the supply is:

• an FDA-approved finished injectable product (with an NDC, labeler, and NDA/ANDA status), or
• API-only supply used in compounding or formulation outside a specific FDA approval route.

A complete supplier list by US manufacturer name requires confirmed product identifiers (NDC/labeler) and FDA review history. Without those identifiers, any named list risks factual errors.

What suppliers can support GMP sterile manufacturing for sodium nitroprusside vials?

Sterile injectable sourcing requires suppliers that can support:

• Aseptic processing or terminal sterilization pathways consistent with the chemical’s stability profile
• Validated in-process controls for reactive inorganic actives
• Container-closure compatibility data (vial, stopper, and headspace considerations)
• Endotoxin/bioburden controls and sterility testing method validation

In the market, this typically narrows the supplier pool to:

• sterile contract manufacturers (if a labeler holds NDA/ANDA or contract labeling rights), or
• domestic sterile manufacturers with established inorganic injectable lines.

What is the typical supply chain for sodium nitroprusside in injectable use?

Common chain-of-custody

1. Upstream inorganic API synthesis (bulk sodium nitroprusside)
2. GMP packing into controlled lot sizes
3. Import and release testing (distributor or importer)
4. Hospital/wholesaler distribution
5. Conversion to clinical-ready form (if not already sterile injectable), often via:
   • in-hospital pharmacy preparation or
   • qualified compounding suppliers, where applicable

Risk points

• Lot-to-lot analytical variance due to sensitive assay behavior
• Documentation gaps for audits and customer qualification
• Regulatory and logistics delays on reactive inorganic inventory

Which supplier qualification standards matter most for reactive inorganic actives like sodium nitroprusside?

Quality system focus

• Reconciliation controls and batch record integrity
• Method robustness for assay and impurity testing
• Traceability of raw material inputs and cleaning validation
• Environmental controls and preventive maintenance schedules
• Change control discipline, especially after upstream synthesis process modifications

Audit focus

• Historical deviations and CAPA timelines
• Out-of-specification rate trend
• Completeness of GMP training and deviations closure effectiveness

Key Takeaways

• Sodium nitroprusside sourcing is typically split between API manufacturers and US importers/distributors, with finished injectable supply dependent on limited GMP sterile capacity.
• For procurement or formulation, buyers should qualify suppliers by GMP documentation, batch traceability, and sterile-handling capability where injectables are required.
• Single-source exposure is a material risk for reactive inorganic actives; qualification of multiple supply lines is standard operating practice.

FAQs

1. How do I find sodium nitroprusside suppliers that provide CoA and GMP documentation by lot?
   Target GMP-capable distributors and API manufacturers that provide lot-level CoA, batch records summary, and audit-ready documentation.

2. Can I buy sodium nitroprusside as an API for sterile compounding?
   Yes, but only through qualified sources that can supply documentation aligned to your compounding and regulatory requirements.

3. What requirements must a supplier meet to ship sodium nitroprusside to the US legally?
   Suppliers and importers must support US registration/listing and provide correct importer-of-record and customs documentation, plus lot release paperwork.

4. What are common reasons sodium nitroprusside supply becomes constrained?
   Upstream inorganic synthesis capacity limits, stability-handling constraints, tight quality control acceptance windows, and sporadic sterile manufacturing availability.

5. How many qualified suppliers should a company maintain for sodium nitroprusside?
   Commonly at least two for API and, if needed for injectables, two for finished-dose or sterile contract supply to reduce interruption risk.

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References

1. FDA. Drugs@FDA database. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
3. FDA. Drug Registration and Listing System (DRLS). https://www.fda.gov/drugs/drug-registration-and-listing-drug-substance-manufacturers-and-distributors-drsl
4. USP. United States Pharmacopeia and National Formulary (USP-NF) general information. https://www.uspnf.com/