Suppliers and packagers for generic pharmaceutical drug: acetohydroxamic acid

acetohydroxamic acid

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mission Pharma	LITHOSTAT	acetohydroxamic acid	TABLET;ORAL	018749	NDA	Mission Pharmacal Company	0178-0500-01	100 TABLET in 1 BOTTLE (0178-0500-01)	1983-05-31

Who Supplies Acetohydroxamic Acid for Pharmaceutical Use?

Last updated: April 23, 2026

Acetohydroxamic acid (AHAA; molecular formula C2H5NO2, often encountered in salt forms such as acetohydroxamate) is supplied globally by chemical manufacturers and specialty intermediates suppliers. The supplier landscape typically splits into (1) chemical-grade producers that supply bulk material and (2) fine-chemical/specialty suppliers that support higher documentation packages used in regulated filings and manufacturing.

What supplier categories carry acetohydroxamic acid?

Bulk chemical manufacturers (commodity to intermediate grade)

These suppliers offer AHAA at scale for research, process, or non-sterile manufacturing inputs. Documentation commonly includes at least CoA and SDS; higher-grade offerings may add GMP options depending on jurisdiction and contract.

Specialty fine-chemical suppliers (documentation-forward)

These suppliers position around catalog fine chemicals and intermediate supply, often with tighter traceability, batch documentation, and customer qualification support.

Salt-form and derivative suppliers

Where acetohydroxamic acid is marketed through formulations or as a specific salt, supplier listings may appear under:

• acetohydroxamic acid (free base)
• acetohydroxamate (salt forms)
• drug-substance specific naming used by contract manufacturers and distributors

Which suppliers are known to supply acetohydroxamic acid?

The most reliable way to validate active commercial supply for acetohydroxamic acid is to use manufacturer and distributor catalogs and confirm:

• product name spelling (acetohydroxamic acid vs acetohydroxamate salts)
• grade designation (technical, USP, EP, reagent, etc.)
• packaging (bottle vs drum vs 25 kg bags vs bulk tank)
• documentation set (SDS, CoA, DMF/CEP status if claimed)

Below is a structured supplier map by role, focused on companies that commonly appear in fine-chemical and pharmaceutical-ingredient supply channels.

Manufacturer and distributor channels to check (global)

• Alfa Aesar (Thermo Fisher Scientific): fine chemicals and reagents catalog coverage; commonly lists acetohydroxamic acid under reagent-grade supply pathways.
• TCI Chemicals: fine-chemical catalog supplier; frequently carries acetohydroxamic-acid listings for laboratory and research procurement.
• Sigma-Aldrich (Merck): reagent and chemical supply; commonly carries AHAA for research sourcing.
• Cayman Chemical: specialty biochemical and research chemical supplier; may list AHAA depending on current catalog.
• Biosynth / Merck Life Science channels (where applicable): catalog suppliers that may stock acetohydroxamic-acid materials through distributor networks.

API and regulated-grade pathways (GMP-oriented)

Regulated-grade availability depends on whether a supplier makes AHAA under GMP (or provides GMP batches) and whether they support:

• DMF/ASMF references (where applicable)
• change control and batch traceability
• viral clearance or hold-time documentation (only when relevant to the manufacturing process)

For AHAA specifically, many customers source through fine-chemical suppliers rather than large API producers unless they require a specific salt form or documented GMP batch supply.

What should procurement teams verify before purchase?

Procurement qualification for acetohydroxamic acid should cover the items below, because they drive downstream regulatory and manufacturing acceptance.

Minimum documentation set

• SDS (Safety Data Sheet)
• CoA (Certificate of Analysis) with tested specs
• Lot traceability (batch number linked to CoA)

Specification and identity checks

• Correct chemical identity (name, CAS, and structural description used by supplier)
• Impurity profile expectations (request or review typical impurity disclosures if provided)
• Water content and related residue specs (if supplied)

Manufacturing and regulatory status

• Whether the supplier can provide GMP-manufactured material and batch-level documentation
• Whether the supplier supports customer audits or qualification packages

What are typical purchasing details to lock in contractually?

Forms and packaging

• Free acid vs specific salt form (do not substitute without written approval)
• Packaging size (common market sizes in chemical catalogs include 1 g to 25 g reagent bottles and 25 kg bulk bags, depending on grade)

Quality agreement points

• Change notification requirements (process, site, raw material, supplier)
• Retention sample policy (how long and how samples are stored)
• Re-test and shelf-life policy by lot

How to map suppliers to use-cases (R&D vs GMP manufacturing)?

If the use-case is R&D or early process development

• Prefer catalog fine-chemical suppliers with fast lead times and standard reagent-grade documentation.
• Confirm purity via CoA and match impurity profile to assay and method requirements.

If the use-case is pilot-to-commercial drug substance

• Require GMP confirmation and batch documentation sufficient for internal QA release.
• Require a quality agreement and a supplier qualification pack aligned to your internal audits and regulatory pathway.

Supplier short-list methodology that reduces failure rates

1. Confirm the exact material form needed (free acid vs salt).
2. Require CoA with identity and purity tests for the same form.
3. Verify whether the supplier can supply GMP documentation for manufacturing needs.
4. Contractually require change control and lot traceability.
5. Ensure the supplier can meet timeline and packaging size needed for your batch plan.

Key Takeaways

• Acetohydroxamic acid sourcing typically comes from fine-chemical and reagent suppliers, with regulated-grade supply depending on whether GMP batches are offered for the exact form required.
• The fastest procurement success comes from verifying identity, grade, documentation, and change control for the specific form (free acid vs salt).
• For manufacturing-bound material, push early for GMP status and a qualification-ready documentation package (CoA plus audit/quality agreement capability).

FAQs

1) Is acetohydroxamic acid usually supplied as the free acid or as a salt?

Suppliers commonly list both, but procurement must match the exact form used in your process specification (free acid versus a particular acetohydroxamate salt).

2) Which supplier types are best for regulated drug-substance manufacturing?

Suppliers that can provide GMP-manufactured batches and batch-level documentation aligned to your quality agreement needs.

3) What documents should be required with every lot?

At minimum: SDS and CoA with lot traceability that matches the exact form you purchased.

4) Can catalog “reagent grade” acetohydroxamic acid be used for clinical or commercial supply?

It depends on GMP requirements and your internal/regulatory pathway; many teams require GMP confirmation and a quality agreement for pilot-to-commercial material.

5) What is the biggest sourcing failure point for acetohydroxamic acid?

Mixing free-acid and salt forms or using a supplier-grade designation that does not support the documentation and quality requirements of the intended manufacturing stage.

References

[1] Thermo Fisher Scientific, Alfa Aesar product listings for acetohydroxamic acid (catalog access).
[2] TCI Chemicals, acetohydroxamic acid catalog listing (catalog access).
[3] Merck/Sigma-Aldrich, acetohydroxamic acid product listing (catalog access).
[4] Cayman Chemical, acetohydroxamic acid catalog listing (catalog access).