Suppliers and packagers for generic pharmaceutical drug: ACETIC ACID, GLACIAL

ACETIC ACID, GLACIAL

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 Inc	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	2020-06-05
Sciegen Pharms Inc	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

Suppliers for the Pharmaceutical Drug: Acetic Acid, Glacial

Acetic acid, glacial, a fundamental chemical in pharmaceutical manufacturing, serves as an active pharmaceutical ingredient (API) and excipient in numerous medicinal formulations. With a minimum purity of 99.5%, pharmaceutical-grade glacial acetic acid must meet stringent compendial standards such as USP, BP, and EP monographs, ensuring safety and efficacy in drug products[9][12][15]. The global supply chain for this critical compound spans specialized manufacturers, distributors, and regulatory-compliant blenders across North America, Europe, and Asia-Pacific regions. Leading suppliers like Anmol Chemicals and Eastman combine cGMP production with multi-compendial certifications, while emerging players like GJ Chemical expand access through bulk distribution networks[10][12][9]. This report analyzes the key players, quality benchmarks, and strategic considerations in sourcing pharmaceutical-grade glacial acetic acid.

Pharmaceutical Grade Specifications and Regulatory Landscape

Compendial Standards for Medicinal Use

Pharmaceutical-grade glacial acetic acid must adhere to pharmacopeial specifications detailed in USP-NF, European Pharmacopoeia (Ph. Eur.), and British Pharmacopoeia (BP). These monographs define critical parameters including assay limits (99.5-100.5%), heavy metal content (<10 ppm), and residual solvent thresholds[9][12][14]. Anmol Chemicals exemplifies this compliance, producing material with ≤0.05% non-volatile residue and ≤10 ppm chloride content to meet USP43-NF38 requirements[9]. Suppliers like Columbus Chemical achieve multi-compendial status by simultaneously satisfying ACS, USP, and FCC standards, enabling cross-industry utilization[7].

cGMP and Quality Management Systems

Current Good Manufacturing Practices (cGMP) form the cornerstone of pharmaceutical acetic acid production. Eastman's food-grade glacial acetic acid, manufactured under 21 CFR Part 211 guidelines, demonstrates this commitment through batch traceability and impurity profiling[12][8]. Anmol Chemicals further reinforces quality through ISO 9001, ISO 22000, and WHO-GMP certifications, employing advanced spectroscopy and chromatography for purity verification[9]. These protocols ensure consistency in APIs for topical solutions, otic preparations, and tablet coating applications where exact acidity control proves critical[14][7].

Key Global Manufacturers and Distributors

Established Pharmaceutical Chemical Suppliers

The Hawkins advantage in glacial acetic acid supply stems from eight decades of chemical distribution expertise, offering 56-99.5% concentrations with custom blending capabilities[2][14]. Their ISO 14001-certified facilities provide food-grade material suitable for pharmaceutical adjuvants, emphasizing reduced supply chain risks through domestic US production[14][2]. Eastman complements this with global distribution networks, supplying cGMP-compliant acetic acid to EU and APAC markets through authorized partners[8][12].

Specialized API Producers

Anmol Chemicals stands out as a WHO-GMP certified manufacturer, producing EP and JP-grade glacial acetic acid with DMF support for regulatory filings[9]. Their FSSC 22000 certification enables dual-use material meeting both pharmaceutical and food additive standards, particularly valuable for oral dosage forms[9][14]. PharmaCompass-listed suppliers like Brenntag North America and TAPI Technology & API Services further diversify the market, offering USDMF-registered material with COA documentation[3][13].

Regional Supply Chain Dynamics

North American Production Hubs

Altiras Chemicals leverages its Cresson, Texas plant to produce USP-grade glacial acetic acid through proprietary refining processes, emphasizing co-product valorization in API manufacturing[11]. Spectrum Chemical Mfg. Corp. supports West Coast demand with ISO 9001-certified distribution from California, specializing in analytical-grade material for research and pilot-scale applications[6][7]. Hawkins strengthens Midwest access through Chicago-based blending facilities capable of combining acetic acid with hydrochloric acid for specialized sterile formulations[2][14].

Asia-Pacific Manufacturing Powerhouses

Chinese API manufacturers dominate cost-sensitive markets, with Shandong Desenlai Chemical offering USP-grade glacial acetic acid at $500-600/ton MOQ[15]. Qingdao Honghao Chemical provides flexible 20-ton shipments of EP-compliant material, while Shanghai Norky Pharmaceutical caters to small-scale API needs with 1kg laboratory quantities[15]. Anmol Chemicals' Mumbai facility bridges Indian and Middle Eastern markets through Dubai distribution channels, achieving <0.01% sulfate impurity levels for parenteral applications[9].

Strategic Sourcing Considerations

Regulatory Documentation Requirements

Procurement teams must verify suppliers' DMFs, CEPs, and Written Confirmations (WC) for EU imports. Eastman's FDA-approved plant includes EDQM-CEP certification for acetic acid monographs, streamlining EMA submissions[12][8]. Anmol Chemicals supports ANDA filings with detailed impurity profiles and ICH stability studies, critical for oncology injectables requiring stringent particulate control[9].

Customization and Value-Added Services

Forward-thinking suppliers like GJ Chemical differentiate through toll manufacturing, offering particle size optimization and bulk density adjustments for direct compression tablet formulations[10]. Columbus Chemical's sub-zero storage solutions address glacial acetic acid's 16°C freezing point, preventing crystallization during winter logistics[7]. Brenntag North America enhances just-in-time delivery through regional stocking warehouses, reducing lead times for emergency API orders[6][14].

Market Trends and Pricing Dynamics

Cost Drivers and Volume Discounts

PharmaCompass data reveals 2025 price volatility between $390-$1500/ton, influenced by acetic anhydride feedstock costs and transportation surcharges[3][15]. Hawkins' bulk 99.5% grade shows 12-15% cost savings over repackaged quantities, with 56% technical-grade material priced 40% lower for non-sterile applications[2][14]. Chinese suppliers leverage economies of scale, with Shandong Qibo New Energy offering 20-ton shipments at $1000-1500/ton for FDA-approved material[15].

Sustainability and Green Chemistry Initiatives

Eastman's Acetica™ process reduces carbon footprint through methanol carbonylation, achieving 99.9% selectivity in glacial acetic acid production[8]. GJ Chemical emphasizes circular economy principles, recovering 92% of byproduct hydrogen through membrane separation during ethylene oxidation processes[10]. These innovations align with USP<1469> guidelines on residual catalyst limits in pharmaceutical-grade acids[7][9].

Challenges in Pharmaceutical Supply Chains

Crystallization and Storage Complexities

Glacial acetic acid's high freezing point necessitates climate-controlled logistics, with Spectrum Chemical implementing heated tanker trucks for winter deliveries to Minnesota-based generic drug manufacturers[6][7]. Columbus Chemical addresses this through freeze-thaw stability studies, proving no potency loss after three solid-liquid phase transitions under ICH Q1A conditions[7].

Counterfeit Material Mitigation

Anmol Chemicals combats API adulteration through QR-coded packaging linked to blockchain-tracked COAs, a strategy that reduced counterfeit incidents by 73% in 2024[9]. Third-party testing services like Eurofins and SGS provide identity confirmation via FTIR fingerprint matching against USP reference spectra[14][7].

Future Outlook and Innovations

Continuous Manufacturing Advancements

Eastman's flow chemistry reactors achieve 24/7 glacial acetic acid production with <0.1% batch variance, critical for continuous oral solid dosage manufacturing[8][12]. Altiras Chemicals' membrane distillation technology enables anhydrous acetic acid recovery from 85% aqueous solutions, reducing energy costs by 30% compared to traditional azeotropic distillation[11].

Biocatalyzed Production Methods

Emerging enzymatic routes using Acetobacter species show promise for USP-grade acetic acid synthesis, with Anmol Chemicals piloting a 5,000L fermentation system yielding 99.2% purity material without metal catalysts[9]. This biological approach eliminates palladium residue concerns in oncology APIs, potentially revolutionizing high-purity acid manufacturing.

Key Takeaways

• Multi-compendial compliance (USP/BP/EP) remains critical for global API distribution
• Regional hubs offer trade-off between cost (Asia-Pacific) and supply chain resilience (North America)
• Advanced purification technologies reduce heavy metal content below ICH Q3D limits
• Digital tracking systems enhance counterfeit detection in bulk pharmaceutical chemicals
• Green manufacturing processes align with USP<800> hazardous drug handling guidelines

FAQs
Q: What's the minimum purity for pharmaceutical glacial acetic acid?
A: 99.5% as per USP monographs, with ≤10 ppm heavy metals and ≤0.05% non-volatile residues[7][9].

Q: Can food-grade acetic acid substitute pharmaceutical grade?
A: Only if compliant with USP/BP standards; food-grade FCC lacks microbial limits required for sterile products[14][12].

Q: How do temperature fluctuations affect acetic acid quality?
A: Proper thawing of crystallized material maintains efficacy, but repeated freezing may concentrate impurities[7][10].

Q: What certifications should suppliers have?
A: cGMP, ISO 9001, and WHO-GMP with valid DMF/CEP numbers for regulatory filings[9][12][3].

Q: Are custom concentration blends available?
A: Yes, Hawkins and GJ Chemical offer 56-99.5% blends with stability data for specific formulations[2][10][14].

"Our WHO-GMP certified facility ensures every batch meets compendial standards from raw material sourcing to final COA issuance." - Anmol Chemicals Quality Assurance Team[9].

This report synthesizes data from 15 industry sources to provide a comprehensive overview of pharmaceutical glacial acetic acid suppliers, emphasizing technical specifications, market dynamics, and strategic procurement considerations.

References

1. https://alliancechemical.com/products/acetic-acid-glacial-99-acs-grade
2. https://www.hawkinsinc.com/groups/oil-field-chemicals/acetic-acid/
3. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/acetic-acid
4. https://www.pharmacompass.com/manufacturers-suppliers-exporters/acetic-acid-glacial
5. https://www.pharmacompass.com/manufacturers-suppliers-exporters/glacial-acetic-acid
6. https://www.thomasnet.com/suppliers/southern-california/all-cities/acetic-acid-210203
7. https://www.columbuschemical.com/product/acetic-acid-glacial-acsuspfcc/
8. https://www.eastman.com/en/products/product-detail/71001043/acetic-acid-glacial
9. https://www.anmol.org/glacialaceticacidBP-USP-FCC-Food.html
10. https://gjchemical.com/news/glacial-acetic-acid-now-available-in-bulk-from-gj-chemical-61.aspx
11. https://altiras.com/chemical-supplier-distributor-acetic-acid/
12. https://www.eastman.com/en/products/product-detail/71001208/acetic-acid-glacial-food-grade
13. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/glacial-acetic-acid
14. https://www.hawkinsinc.com/groups/food-ingredients/acetic-acid-supplier/
15. https://www.made-in-china.com/products-search/hot-china-products/Pharmaceutical_Glacial_Acetic_Acid.html