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

Last updated: August 1, 2025

Introduction

Acetic acid, glacial, is a high-purity form of acetic acid used extensively in pharmaceutical manufacturing, research, and chemical synthesis. Its demand spans multiple industries, driven by stringent quality requirements for pharmaceutical applications. Identifying reliable suppliers is crucial for pharmaceutical companies to ensure product consistency, regulatory compliance, and supply chain resilience. This article provides a comprehensive overview of key global suppliers of glacial acetic acid, considering their manufacturing capabilities, quality standards, certification, and market presence.

Understanding Glacial Acetic Acid in Pharmaceuticals

Glacial acetic acid is a concentrated, 99.5% or higher purity solution of acetic acid, characterized by its ability to solidify into ice-like crystals at low temperatures. In pharmaceuticals, it functions as a reagent in drug synthesis, excipients, and formulations where ultra-pure acetic acid is essential. The efficacy of pharmaceutical processes hinges on the supply of high-grade raw materials, making supplier reliability vital.

Major Global Suppliers of Glacial Acetic Acid

1. Eastman Chemical Company

Overview:
Eastman Chemical is a leading manufacturer supplying high-quality acetic acid derivatives, including glacial acetic acid, with a global distribution network. Its manufacturing facilities in the US and Europe produce acetic acid meeting pharmaceutical-grade specifications.

Key Attributes:

• Product Quality: Certified for pharmaceutical applications, adhering to USP, EP, and JP standards.
• Capacity: Large-scale production with an annual output enabling stable supply.
• Certifications: ISO 9001, ISO 14001, and cGMP compliance, essential for pharmaceutical-grade manufacturing.
• Markets Served: North America, Europe, Asia, with tailored logistics solutions.

Supply Reliability:
Eastman emphasizes their integrated manufacturing process and global footprint, ensuring supply stability amid global disruptions.

2. BP Chemicals (British Petroleum Chemicals)

Overview:
BP’s chemical division is a durable supplier of acetic acid, including glacial varieties, with a focus on pharmaceutical and industrial markets.

Key Attributes:

• Product Quality: Meets pharmaceutical standards, with rigorous quality control protocols.
• Manufacturing: Facilities in the UK and the US enable consistent supply to global markets.
• Certifications: GMP-certified, with ISO accreditation ensuring compliance with pharmaceutical industry needs.

Market Presence:
BP leverages its longstanding experience and global logistics network to serve major pharmaceutical clients worldwide.

3. Jubilant Life Sciences

Overview:
An Indian-based pharmaceutical and chemical manufacturer, Jubilant Life Sciences specializes in the production of acetic acid and derivatives.

Key Attributes:

• Product Range: Offers high-purity acetic acid with pharmaceutical specifications.
• Certifications: GMP, ISO 9001, and cGMP for pharmaceutical-grade products.
• Capacity & Expansion: Continual capacity enhancement to meet growing demand in Asian and global markets.

Market Focus:
Jubilant’s strategic focus on compliance and quality makes it a significant supplier for API manufacturers and pharma companies seeking reliable sourcing from Asia.

4. Celanese Corporation

Overview:
Celanese is a global technology and specialty materials player, providing acetic acid with high purity and stability.

Key Attributes:

• Product Certifications: Meets USP, EP, and JP standards for pharmaceutical compatibility.
• Supply Scope: Extensive production facilities across North America, Europe, and Asia.
• Research & Development: Focused on enhancing purity and process optimization for pharmaceutical applications.

Reputation:
Celanese’s commitment to quality and innovation makes it a preferred supplier within regulated industries.

5. Anhui Huaiyuan Chemical Industry Co., Ltd.

Overview:
A prominent Chinese chemical manufacturer specializing in acetic acid and derivatives, with growing recognition in the pharmaceutical supply chain.

Key Attributes:

• Product Quality: Offers pharmaceutical-grade glacial acetic acid compliant with Chinese and international standards.
• Regulatory Status: Possesses IS0 and GMP certifications, increasingly aligning with global standards.
• Market Reach: Expanding export capabilities catering to global pharmaceutical companies seeking cost-competitive sources.

Considerations:
Regulatory diligence is advised due to variability in certification and quality assurance protocols across regions.

Criteria for Selecting a Glacial Acetic Acid Supplier

When choosing suppliers for pharmaceutical-grade glacial acetic acid, key criteria include:

• Quality Certifications: Ensure compliance with USP, EP, or JP standards, along with GMP and ISO certifications for manufacturing processes.
• Purity & Specifications: Confirm the purity level is 99.5% or higher, suitable for pharmaceutical use.
• Supply Capacity & Stability: Evaluate the ability to meet demand fluctuations and ensure supply chain resilience.
• Regulatory Compliance: Suppliers should regularly audit and update compliance to evolving pharmaceutical standards.
• Traceability & Documentation: Robust documentation including Certificates of Analysis (CoA), manufacturing records, and batch traceability.

Emerging Trends & Considerations

1. Regional Shifts & Diversification

Increasing geopolitical tensions and the COVID-19 pandemic highlighted the importance of diversified supply chains. Companies are actively sourcing from multiple regions, including Asia, Europe, and North America, to mitigate risks.

2. Sustainability & Green Manufacturing

Regulators and consumers are emphasizing environmentally sustainable practices. Suppliers adopting eco-friendly manufacturing processes, reducing carbon footprints, and obtaining environmental certifications are gaining preference.

3. Regulatory Harmonization & Global Standards

Global regulatory bodies are harmonizing standards, which simplifies supplier qualification processes. Suppliers that proactively align with international standards exhibit higher credibility.

4. Technological Innovations

Advanced monitoring, automation, and quality control technologies improve product consistency, traceability, and compliance, further empowering buyers to select reliable suppliers.

Conclusion

Securing a stable supply of pharmaceutical-grade glacial acetic acid requires understanding the landscape of global suppliers. Industry leaders such as Eastman, BP Chemicals, Jubilant, Celanese, and Chinese manufacturers like Anhui Huaiyuan are pivotal in fulfilling demand. Selection should prioritize quality certifications, capacity, compliance, and supply stability. As supply chains evolve, diversification, sustainability, and technological advancements will increasingly influence procurement strategies.

Key Takeaways

• Prioritize Certification & Quality: Ensure suppliers meet USP, EP, or JP standards and hold GMP, ISO certifications.
• Assess Capacity & Reliability: Choose suppliers with sufficient volume capabilities and proven supply stability to prevent disruptions.
• Diversify Sources: Reduce dependency on single regions or suppliers to mitigate geopolitical and logistical risks.
• Focus on Sustainability: Opt for suppliers adopting green manufacturing practices aligning with regulatory and corporate sustainability goals.
• Monitor Regulatory Compliance: Maintain continuous oversight to ensure supplier compliance with evolving international standards.

FAQs

Q1: What are the main quality standards for pharmaceutical-grade glacial acetic acid?
A1: The primary standards include the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopeia (JP). These standards specify purity levels (≥99.5%), impurity limits, and testing protocols.

Q2: How can I verify a supplier's compliance with pharmaceutical standards?
A2: Request Certificates of Analysis (CoA), GMP certifications, and audit reports. Conduct on-site audits if necessary, and verify supplier accreditation with recognized regulatory authorities.

Q3: Are Chinese manufacturers reliable sources for pharmaceutical-grade glacial acetic acid?
A3: Many Chinese suppliers have improved quality control and obtained international certifications. However, due diligence is necessary to ensure regulatory compliance, proper certification, and consistent quality.

Q4: How does supply chain diversification mitigate procurement risks?
A4: Diversification prevents over-reliance on specific regions or suppliers, reducing vulnerability to geopolitical, logistical, or production disruptions, thus ensuring continuous supply.

Q5: What role do sustainability practices play in supplier selection?
A5: Sustainable practices demonstrate commitment to environmental responsibility, align with regulatory trends, and often indicate rigorous quality and safety standards, making such suppliers more trustworthy.

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Sources:
[1] Eastman Chemical Company, Official Website.
[2] BP Chemicals, Product Portfolio.
[3] Jubilant Life Sciences, Corporate & Product Information.
[4] Celanese Corporation, Product Data Sheets.
[5] Industry Analysis Reports on Pharmaceutical Raw Material Suppliers.