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 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
Sciegen Pharms Inc	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 for the Pharmaceutical Drug: Acetic Acid

Last updated: August 5, 2025

Introduction

Acetic acid, a fundamental chemical worldwide, finds extensive use across the pharmaceutical industry, especially in drug synthesis, formulation, and manufacturing processes. Its applications include pH regulation, solvent use, and as an intermediate in the synthesis of various active pharmaceutical ingredients (APIs). Given its critical role, identifying reliable suppliers is essential for pharmaceutical manufacturers aiming to ensure consistent quality, compliance with regulatory standards, and cost-effectiveness. This article examines the leading suppliers of acetic acid globally, highlighting their capabilities, market positioning, and strategic importance within the pharmaceutical supply chain.

Global Market Overview

The global acetic acid market is projected to grow steadily, driven by expanding chemical manufacturing, pharmaceutical sector demands, and regional industrialization. According to recent market reports, Asia-Pacific remains the dominant producer and consumer of acetic acid, with China, India, and South Korea leading the supply chain. North America and Europe serve as key markets emphasizing high purity standards and regulatory compliance. Suppliers in these regions are integral to pharmaceutical firms requiring high-grade, pharmaceutical-grade acetic acid, typically classified as USP (United States Pharmacopeia) grade or EP (European Pharmacopoeia) grade.

Major Suppliers of Pharmaceutical-Grade Acetic Acid

1. Eastman Chemical Company

Eastman is a prominent global chemical supplier with extensive manufacturing capabilities in acetic acid production. Its products meet rigorous pharmaceutical standards, including USP and GPS (Good Pharmaceutical Supply) quality specifications. Eastman's acetic acid is sourced via methanol carbonylation, ensuring high purity and consistent quality vital for pharmaceutical applications.

Key Highlights:

• Large-scale production facilities in the U.S., Belgium, and China
• Focus on sustainable manufacturing with reduced environmental impact
• Strong global distribution network ensuring timely delivery 

2. Celanese Corporation

Celanese is a leading producer specializing in acetate chemicals, including pharmaceutical-grade acetic acid. Their offerings are known for high purity and compliance with regulatory standards. The company's strategic integration of manufacturing and R&D enables the development of tailored solutions for pharmaceutical clients.

Key Highlights:

• Manufacturing plants across North America, Europe, and Asia
• ISO-certified facilities ensuring quality management and traceability
• Emphasis on environmentally responsible production processes

3. Anhui Wanwei Group

Based in China, Anhui Wanwei is one of the largest producers of acetic acid globally, with an increasing focus on pharmaceutical-grade supply. Their capacity to produce high-purity acetic acid and participate in joint ventures with multinational corporations enhances their supply reliability.

Key Highlights:

• Extensive manufacturing infrastructure in China and Vietnam
• Investment in advanced purification technologies to meet pharmaceutical standards
• Competitive pricing making Wanwei a preferred supplier in Asia-Pacific

4. BASF SE

BASF, a German chemical powerhouse, supplies high-purity acetic acid suitable for pharmaceutical production. Their products adhere to international quality standards, and they offer comprehensive supply chain solutions.

Key Highlights:

• Global production sites, including Europe, Asia, and North America
• Commitment to sustainability and regulatory compliance
• Extensive R&D supporting formulation innovations

5. Jiangsu Sopo (Sopo Chemicals)

A key Chinese chemical producer, Jiangsu Sopo offers high-quality acetic acid for pharmaceutical applications. Their ability to scale production while maintaining strict quality control makes them a significant supplier in the Asia-Pacific region.

Key Highlights:

• Focus on high-purity, pharmaceutical-grade products
• Strong regional distribution network
• Competitive pricing coupled with reliable quality assurance

Quality and Regulatory Standards

Suppliers of pharmaceutical-grade acetic acid must adhere to strict standards, including ISO certifications, GMP (Good Manufacturing Practices), and compliance with pharmacopoeia monographs such as USP, EP, and JP (Japanese Pharmacopoeia). These standards guarantee the chemical's purity, stability, and suitability for medicinal use.

Supply Chain Considerations

Pharmaceutical companies seek suppliers that offer not only high purity products but also robust supply chain reliability, traceability, and flexibility. Long-term relationships with suppliers like Eastman and Celanese often provide assurance of consistent supply, reducing production risks. Additionally, regional suppliers such as Wanwei and Jiangsu Sopo facilitate procurement advantages within Asia, notably China, India, and Southeast Asia.

Emerging Trends and Strategic Implications

• Sustainability Initiatives: Suppliers are investing in environmentally friendly manufacturing processes, such as employing bio-based feedstocks and reducing carbon footprints to meet regulatory and corporate social responsibility standards.

• Diversification of Supply Sources: To mitigate risks of supply disruption, pharmaceutical firms increasingly diversify supplier bases, especially in Asia-Pacific, where the majority of acetic acid production occurs.

• Technological Innovation: Advanced purification and stabilization techniques are enhancing the quality profiles of acetic acid, enabling broader pharmaceutical applications, including sterile and injectable forms.

• Regulatory Alignment: Suppliers are proactively aligning with evolving global regulations pertaining to chemical safety, environmental impact, and traceability to maintain market access.

Conclusion

The reliable supply of pharmaceutical-grade acetic acid is vital for pharmaceutical manufacturing processes. Leading global suppliers such as Eastman, Celanese, BASF, Anhui Wanwei, and Jiangsu Sopo dominate the market, offering high purity, regulatory compliance, and supply security. Strategic sourcing decisions hinge on quality assurance, supply reliability, regulatory adherence, and regional considerations. As the pharmaceutical industry continues to evolve with greater emphasis on sustainability and technological innovation, suppliers responding proactively will maintain their competitive edge and support the evolving needs of pharmaceutical producers.

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Key Takeaways

• Major suppliers of pharmaceutical-grade acetic acid include Eastman, Celanese, BASF, Anhui Wanwei, and Jiangsu Sopo, each with extensive regional manufacturing capabilities.
• Quality compliance with pharmacopoeia standards (USP, EP, JP) and certifications (ISO, GMP) is critical for pharmaceutical applications.
• Supply chain resilience involves diversification of sourcing, especially with regional suppliers in Asia-Pacific, to prevent disruption risks.
• Sustainability and technological innovation are increasingly influencing supplier strategies and product offerings.
• Contracting with a trusted supplier ensures consistent quality, regulatory adherence, and reliable delivery timelines essential for pharmaceutical manufacturing.

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FAQs

1. What specifications must acetic acid meet for pharmaceutical use?
Pharmaceutical-grade acetic acid must comply with pharmacopoeia standards such as USP or EP, requiring specific purity levels (generally >99.8%), low water content, and absence of impurities like aldehydes, acids, and heavy metals.

2. How do regional suppliers benefit pharmaceutical companies?
Regional suppliers, particularly in Asia, offer cost advantages, shorter lead times, and better supply flexibility, which is critical for localized manufacturing efforts and global supply chain optimization.

3. What are the environmental considerations for acetic acid suppliers?
Suppliers are increasingly adopting sustainable practices like eco-friendly feedstocks, energy-efficient processes, and waste reduction initiatives to meet global environmental regulations and corporate ESG targets.

4. How does regulatory compliance influence supplier selection?
Regulatory compliance ensures products meet safety and efficacy standards, reduces compliance risks, and facilitates smoother approval processes for pharmaceutical manufacturers using the acetic acid.

5. Are there risks associated with sourcing acetic acid from emerging suppliers?
Risks include variability in product quality, supply stability, and regulatory adherence. Due diligence, quality audits, and supplier certifications mitigate these risks and ensure supply chain integrity.

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Sources

[1] MarketsandMarkets. “Acetic Acid Market by Application, Region — Global Forecast to 2028.”
[2] Grand View Research. “Pharmaceutical Chemicals Market Analysis & Trends.”
[3] Eastman Chemical Company. Product datasheets and sustainability reports.
[4] Celanese Corporation. Product specifications and global manufacturing overview.
[5] BASF SE. Sustainability and quality assurance documentation.