Suppliers and packagers for ACETIC ACID

ACETIC 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
Chartwell Rx	ACETIC ACID	acetic acid, glacial	SOLUTION/DROPS;OTIC	040166	ANDA	Chartwell RX, LLC	62135-801-51	15 mL in 1 BOTTLE (62135-801-51)	1996-07-26
Sciegen Pharms	ACETIC ACID	acetic acid, glacial	SOLUTION/DROPS;OTIC	040607	ANDA	A-S Medication Solutions	50090-6527-0	1 BOTTLE in 1 CARTON (50090-6527-0) / 15 mL in 1 BOTTLE	2020-06-01
Sciegen Pharms	ACETIC ACID	acetic acid, glacial	SOLUTION/DROPS;OTIC	040607	ANDA	TruPharma, LLC	52817-816-15	1 BOTTLE in 1 CARTON (52817-816-15) / 15 mL in 1 BOTTLE	2020-06-01
Sciegen Pharms	ACETIC ACID	acetic acid, glacial	SOLUTION/DROPS;OTIC	040607	ANDA	NuCare Pharmaceuticals,Inc.	68071-2984-5	1 BOTTLE in 1 CARTON (68071-2984-5) / 15 mL in 1 BOTTLE	2020-06-05

Suppliers and packagers for ACETIC ACID

Last updated: June 1, 2026

Acetic Acid Pharmaceutical Suppliers: Who Provides Bulk, USP/EP Grades, and Contract Manufacturing

Executive summary: Acetic acid is a commodity chemical used directly and as a processing input across pharmaceutical manufacturing. Supply comes from large commodity chemical producers, specialty chemical suppliers carrying pharmacopoeial grades (USP/EP), and contract manufacturers that formulate or package acetic acid derivatives (including buffered acetic acid and related excipient solutions). The supplier landscape is broad, with substitution risk low because most pharmaceutical use depends on pharmacopoeial compliance and concentration specs rather than proprietary IP.

Which companies supply USP and EP acetic acid for pharmaceutical use?

Featured supplier categories for pharmaceutical-grade acetic acid fall into three buckets.

1) Large commodity chemical producers

These firms typically sell acetic acid in bulk and also provide higher-purity grades suitable for downstream pharmaceutical and excipient supply chains, depending on customer qualification and documentation. Their strength is volume, continuity of supply, and global distribution.

2) Specialty chemical and excipient distributors

Distributors and specialty suppliers often provide the documentation and batch traceability pharmaceutical customers require, including COA, impurity profiles, and pharmacopoeial compliance mapping to USP/NF and/or Ph. Eur. Their strength is product handling and faster qualification.

3) Contract manufacturers and packaging specialists

Some suppliers focus on repackaging, blending to target concentrations, and producing defined solutions (for example, standardized acetic acid solutions used in analytical or formulation contexts). Their strength is packaging, labeling, and small-to-mid scale supply reliability.

What grades of acetic acid are required for pharma (USP, NF, EP, BP)?

Pharmaceutical buyers typically qualify acetic acid to one or more pharmacopoeial listings or internal specs tied to impurity limits and residue controls.

Key spec drivers

• Concentration (glacial vs specified % w/w solutions)
• Acetic acid assay and acidity
• Aldehydes/ketones, heavy metals, water content (where applicable)
• Non-volatile residues and specific impurity panels
• Microbiological and endotoxin controls only when used in sensitive contexts (e.g., certain processing steps or aqueous solutions)

Regulatory-facing documentation buyers request

• USP/EP compliance statements (as applicable)
• Lot-based COAs (assay, impurities, metals, residue)
• Impurity profiling aligned to customer risk assessments
• Shipping, storage, and container compatibility statements

Are there preferred acetic acid suppliers by concentration or dosage form?

Yes, supply alignment depends on end-use concentration and how the acid is used in manufacturing.

Glacial acetic acid (high concentration)

Usually sourced from commodity producers with robust bulk logistics. Pharmaceutical qualification hinges on impurity profiles and consistent assay.

Dilute acetic acid solutions

More often supplied through specialty chemical firms or repackagers to control concentration tolerances, container type, and stability.

Buffered acetic acid and derivative solutions

If a formulation requires controlled buffering strength, supply usually shifts toward contract manufacturers or excipient-focused suppliers that deliver standardized solutions.

How do pharmaceutical buyers evaluate and qualify acetic acid suppliers?

Qualification is a document-and-test process with a risk-based approach.

Common qualification steps

• Vendor onboarding (quality agreements, audit or supplier qualification documentation)
• COA review and impurity acceptance criteria
• Material safety and compatibility assessment
• Traceability verification (batch/lot mapping)
• Change control review (process changes, source changes, container changes)
• Ongoing stability and retest requirements consistent with intended use

IP and exclusivity

Acetic acid is not protected by typical drug substance exclusivity frameworks. Supplier switching is usually constrained by regulatory qualification, not patent exclusivity.

Which supplier selection risks matter most for acetic acid?

Supply continuity

Acetic acid availability can swing with feedstock economics and regional operating rates, so qualification often includes supply redundancy.

Quality variability

Even for commodity chemicals, impurity drift can matter in downstream steps. Buyers manage this with tighter acceptance specs and ongoing trending.

Regulatory fit

Some suppliers can map product to USP/EP listings, but the documentation package varies. Pharmaceutical buyers weight COA completeness and pharmacopoeial statements heavily.

What contract manufacturing or repackaging options exist for pharmaceutical acetic acid?

Contract services typically include:

• Repackaging into pharma-compatible containers (IBC, jerrycans, drums, or smaller bottles for labs)
• Standardizing to target concentrations
• Blending (where permitted) for controlled acidity targets
• Quality documentation services (COA generation, labeling, batch numbering)

These services reduce lead times and simplify inbound logistics for formulation teams.

Which regions have the most acetic acid sourcing options for pharma?

Sourcing commonly concentrates in:

• Europe: access to EP-referenced quality documentation pipelines and local distribution
• North America: strong logistics for repackaging and compliance support
• Asia-Pacific: large production base, often with multiple export-capable suppliers

The practical determinant is the ability to provide compliant COAs and consistent impurity panels.

How does acetic acid compare to other “acid” excipients suppliers (citric acid, hydrochloric acid)?

Acetic acid supply behaves like a commodity acid: many sources, broad substitution, and quality qualification based on impurities and concentration.

• Citric acid and hydrochloric acid can have different impurity profiles and different downstream compatibility constraints.
• Acetic acid substitution risk is typically lower when the downstream process is tolerant to the acid type and the key spec is acidity and impurity control.

Key Takeaways

• Acetic acid for pharma use is sourced from commodity chemical producers, specialty chemical suppliers with USP/EP-aligned documentation, and packaging/repackaging partners that standardize concentration and provide pharma-grade COAs.
• Supplier qualification focuses on pharmacopoeial-grade compliance, impurity profiling, concentration tolerances, batch traceability, and ongoing change control.
• Switching suppliers is usually a quality-regulatory exercise rather than an IP-driven barrier.

FAQs

1) What is the difference between glacial acetic acid and acetic acid solutions for pharmaceutical use?
Glacial is high concentration with tighter controls needed for downstream dosing of acidity, while solutions are supplied at defined concentrations with tolerances managed by repackaging or formulation providers.

2) What documents do pharmaceutical buyers require from acetic acid suppliers?
Batch COAs (assay, impurities, metals/residues), pharmacopoeial compliance statements where applicable, lot traceability, and quality agreements covering change control.

3) Can acetic acid be sourced from multiple suppliers without formulation changes?
Often yes if impurity profiles and concentration specs match the downstream process acceptance criteria and the buyer completes qualification and trending.

4) Does acetic acid have to be sterile for pharmaceutical manufacturing?
Not typically as a default commodity input. Sterility requirements depend on the specific step and whether it contacts sterile product or sensitive aqueous formulations.

5) Is acetic acid supply impacted by patents or FDA exclusivity?
No. Acetic acid is not subject to drug exclusivity frameworks; supply is driven by chemical production economics and quality qualification.

References

No sources provided in the request.