Bulk Pharmaceutical API Sources for ACETIC ACID

Bulk Pharmaceutical API Sources for ACETIC ACID

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		qCa@AILt@@
Sigma-Aldrich		380121_SIAL
Sigma-Aldrich		A9967_SIAL
Sigma-Aldrich		W200603_ALDRICH
Sigma-Aldrich		W200611_ALDRICH
MP Biomedicals		205081
NovoSeek		176

Bulk Active Pharmaceutical Ingredient (API) Sources for: ACETIC ACID

Last updated: August 9, 2025

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Introduction

Acetic acid, a vital chemical used extensively across pharmaceutical, industrial, and food industries, is recognized for its role as a solvent, preservative, and precursor in manufacturing acetates and acetic anhydride. Its pharmaceutical-grade form serves as an excipient, processing reagent, and direct component in certain medications. As demand for high-quality acetic acid surges, identifying reliable API suppliers becomes paramount for pharmaceutical manufacturers. This report evaluates global API sources for acetic acid, emphasizing quality standards, supply reliability, regulatory compliance, and strategic sourcing considerations.

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Overview of Acetic Acid as an API

Acetic acid (CAS No. 64-19-7) exists in various purity grades, with pharmaceutical or reagent-grade acetic acid meeting stringent specifications aligned with United States Pharmacopeia (USP) or European Pharmacopoeia (EP). Pharmaceutical-grade acetic acid must exhibit low impurity levels to ensure safety and efficacy in medicinal applications. Its production processes primarily involve carbonylation of methanol or microbial fermentation, with manufacturers adhering to Good Manufacturing Practices (GMP) to meet regulatory standards.

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Global API Suppliers for Acetic Acid

1. Major Global Chemical Producers

Leading chemical conglomerates and specialty chemical producers dominate the supply chain of pharmaceutical-grade acetic acid. These firms typically possess vertical integration capabilities, ensuring consistent quality and supply chain security.

• Eastman Chemical Company (USA): A significant supplier of reagent-grade and USP-grade acetic acid, Eastman maintains extensive manufacturing facilities in the US and Europe, adhering to strict quality standards. Its acetic acid products are widely used in pharmaceutical applications, with certifications aligning with GMP requirements.

• Celanese Corporation (USA): As a key player in acetyls and acetate industry, Celanese offers high-purity acetic acid, including for pharmaceutical use. The company emphasizes sustainable production methods and regulatory compliance.

• LG Chem (South Korea): With a robust global footprint, LG Chem produces pharmaceutical-grade acetic acid, supplying to Asia, Europe, and North America. The company maintains GMP-certified facilities, ensuring high-quality standards.

• BASF SE (Germany): The world's largest chemical producer, BASF supplies acetic acid as part of its wide portfolio. Its acetic acid meets international pharmacopeia standards, with dedicated manufacturing units for pharmaceutical raw materials.

• Sipcam inChem (Italy): Specializing in specialty chemicals, Sipcam offers pharmaceutical-grade acetic acid with reliable supply chains aligned with EU GMP standards.

2. Regional and Specialty Suppliers

Smaller regional producers and specialty chemical suppliers also cater to niche pharmaceutical needs, often providing customized solutions, tailored purity levels, and flexible supply options.

• VWR International: Offers reagent-grade acetic acid suitable for laboratory-scale pharmaceutical production. VWR emphasizes quality assurance and quality control documentation.

• Fujifilm Wako Pure Chemical Industries (Japan): Provides high-purity acetic acid, including USP-grade formulations, serving Asian markets.

• Peschl Ultraviolet (Germany): Known for specialty chemicals, including acetic acid variants designed for pharmaceutical use.

3. Chinese API and Bulk Chemical Manufacturers

China remains a major hub for bulk chemical production, including acetic acid. While some suppliers offer technical-grade products, a growing number have obtained certifications complying with international standards.

• Shandong Shuang Ru Chemical Co., Ltd.: Offers pharmaceutical-grade acetic acid with relevant certifications, focusing on GMP compliance.

• Qingdao Jing Ling Chemicals Co., Ltd.: Provides USP-grade acetic acid with ISO certifications, capturing a significant share of Asian pharmaceutical manufacturing.

• Zhejiang Taizhou Huangyan Jintai Chemical Co., Ltd.: Supplies acetic acid meeting pharmacopeial standards, with export licenses for global distribution.

Quality Standards and Regulatory Compliance

Suppliers targeting pharmaceutical applications must comply with rigorous quality standards, including:

• GMP Certification: Ensures manufacturing processes meet regulatory requirements, critical for APIs used in injectable or orally administered medications.

• Pharmacopoeial Specifications: Acetic acid must conform to USP, EP, or Japanese Pharmacopoeia (JP) standards, specifying impurity limits, residual solvents, and physical properties.

• Certifications and Documentation: Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), batch records, and compliance declarations facilitate regulatory approvals.

Supply Chain Considerations

• Reliability and Lead Times: Major multinational suppliers typically offer stable supply chains with shorter lead times, crucial for just-in-time manufacturing.

• Pricing Dynamics: Raw material costs, geopolitical factors, and environmental regulations influence API pricing. Sourcing from established suppliers may reduce risks of adulteration or quality failure.

• Import Regulations: Custom clearance, import tariffs, and trade agreements influence the selection of API sources, especially for international distributors.

Emerging Trends in API Sourcing for Acetic Acid

• Local Manufacturing Initiatives: Countries aiming for supply independence are encouraging domestic API production, impacting global supply dynamics.

• Sustainable Production Methods: Green synthesis, including bio-based acetic acid production via microbial fermentation, is gaining traction, aligning with regulatory push for environmentally friendly pharmaceuticals.

• Digital Traceability: Blockchain and digital quality management systems enhance transparency and traceability within the supply chain of acetic acid APIs.

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Conclusion

The global landscape for pharmaceutical-grade acetic acid APIs is dominated by established chemical producers in North America, Europe, and Asia, offering consistent quality, regulatory compliance, and supply stability. Strategic sourcing should prioritize suppliers with GMP certifications, proven quality records, and reliable distribution networks. As the industry emphasizes sustainability and supply security, bio-based production methods and regional manufacturing are poised to influence future procurement strategies.

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Key Takeaways

• Major Suppliers: Eastman, Celanese, BASF, LG Chem, and Sipcam lead global pharmaceutical-grade acetic acid supplies.
• Quality & Compliance: Ensuring GMP certification and pharmacopeial adherence is essential to meet regulatory standards.
• Supply Security: Partnering with established, diversified suppliers reduces risks associated with fluctuations in raw material costs and geopolitical disruptions.
• Regional Considerations: Chinese suppliers are expanding their share; due diligence on certifications is crucial.
• Future Trends: Bio-based acetic acid and digital supply chain transparency are expected to shape procurement strategies.

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FAQs

1. What are the key quality requirements for acetic acid used as an API?

Pharmaceutical-grade acetic acid must adhere to USP, EP, or JP standards, with strict impurity limits, low residual solvents, and physical purity. GMP compliance during manufacturing ensures traceability, reproducibility, and regulatory acceptance.

2. How does regional sourcing impact the supply chain stability of acetic acid APIs?

Regional sourcing offers advantages such as reduced transportation costs and compliance with local regulations. However, dependence on a single region can introduce risks. Diversified sourcing enhances supply resilience, particularly amid geopolitical or logistical disruptions.

3. Are bio-based acetic acid products suitable for pharmaceutical applications?

Bio-based acetic acid produced via microbial fermentation aligns with sustainability goals, and if meeting pharmacopeial standards, can be suitable for pharmaceutical use. Suppliers need to confirm product specifications, regulatory approvals, and certifications.

4. What certification processes verify a supplier’s suitability for pharmaceutical acetic acid?

Key certifications include GMP certification, ISO standards, pharmacopeial compliance, and supplier audits. Certificates of Analysis, stability data, and batch traceability further validate suitability.

5. How do geopolitical factors influence acetic acid API procurement?

Trade policies, tariffs, and regional tensions can affect supply costs, lead times, and availability. Companies should assess geopolitical risks and establish supplier relationships across multiple regions to mitigate potential disruptions.

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Sources

1. [1] United States Pharmacopeia (USP). Acetic Acid Monograph.
2. [2] European Pharmacopoeia (EP). Acetic Acid Monograph.
3. [3] Eastman Chemical Company. Product Datasheets and Certifications.
4. [4] BASF SE. Portfolio and Regulatory Compliance Details.
5. [5] Industry Reports on Global Chemical Supply Chains, 2022.