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

ACETIC ACID, GLACIAL; HYDROCORTISONE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cosette	HYDROCORTISONE AND ACETIC ACID	acetic acid, glacial; hydrocortisone	SOLUTION/DROPS;OTIC	040609	ANDA	Cosette Pharmaceuticals, Inc.	0713-0849-09	1 BOTTLE in 1 CARTON (0713-0849-09) / 10 mL in 1 BOTTLE	2024-02-01
Taro	HYDROCORTISONE AND ACETIC ACID	acetic acid, glacial; hydrocortisone	SOLUTION/DROPS;OTIC	088759	ANDA	Sun Pharmaceutical Industries, Inc.	51672-3007-1	1 BOTTLE in 1 CARTON (51672-3007-1) / 10 mL in 1 BOTTLE	2005-04-28
Saptalis Pharms	VOSOL HC	acetic acid, glacial; hydrocortisone	SOLUTION/DROPS;OTIC	012770	NDA AUTHORIZED GENERIC	Saptalis Pharmaceuticals, LLC	71656-064-10	1 BOTTLE, DROPPER in 1 CARTON (71656-064-10) / 10 mL in 1 BOTTLE, DROPPER	2024-02-23

Suppliers for the Pharmaceutical Drugs: Acetic Acid, Glacial; Hydrocortisone

Introduction
The pharmaceutical sector relies heavily on a robust supply chain to ensure the continuous availability of active pharmaceutical ingredients (APIs). Among these essential compounds, glacial acetic acid and hydrocortisone play critical roles in manufacturing various formulations. Identifying leading suppliers for these chemicals is vital for manufacturers, regulatory bodies, and investors seeking supply security, cost-efficiency, and quality assurance. This report provides a comprehensive overview of global suppliers for glacial acetic acid and hydrocortisone, focusing on their manufacturing capacities, quality standards, geographic distribution, and market positioning.

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Suppliers of Glacial Acetic Acid

Overview
Glacial acetic acid is a high-purity form of acetic acid (usually >99.8%) used extensively in pharmaceutical manufacturing, food processing, and chemical synthesis. Its demand correlates with sectors such as pharmaceuticals, cosmetics, and industrial processing.

Key Global Suppliers

1. Eastman Chemical Company
   Eastman is among the largest producers of acetic acid globally, including glacial acetic acid, with manufacturing facilities in North America and Europe. The company's products meet rigorous international quality standards, including USP and EP monographs, catering specifically to pharmaceutical applications. Eastman emphasizes sustainability initiatives and consistent supply chain reliability.

2. Celanese Corporation
   Based in the U.S., Celanese operates several chemical plants producing high-purity acetic acid. Their product portfolio for pharmaceutical use complies with cGMP standards, making them a preferred supplier for API manufacturers targeting regulated markets. Celanese's global distribution network ensures worldwide availability.

3. LyondellBasell Industries
   With a significant presence in Europe and North America, LyondellBasell supplies glacial acetic acid to pharmaceutical and chemical companies. They focus on high-quality, industrial-grade acetic acid with certifications aligning with pharmaceutical industry requirements.

4. Yangzhou Chenhua Chemical Co., Ltd. (China)
   A major Chinese manufacturer specializing in high-purity organic chemicals, Chenhua offers glacial acetic acid at competitive prices. The company has received GMP and ISO certifications, positioning itself as a growing supplier to Asian and international pharmaceutical companies.

5. Xinjiang Zhongtai Chemical Co., Ltd. (China)
   Specialized in chemical manufacturing, Zhongtai produces high-grade acetic acid with a focus on export markets. Their operations adhere to international quality standards, and they are expanding their global footprint to meet increasing demand.

Market Dynamics & Considerations

• Quality Certifications: Suppliers supporting pharmaceutical manufacturing must possess relevant certifications such as USP, EP, GMP, ISO 9001.
• Supply Security: Leading suppliers with diversified production sites mitigate risks related to regional disruptions.
• Pricing & Logistics: Chinese manufacturers often offer cost advantages but may face logistical and compliance considerations for exports.

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Suppliers of Hydrocortisone

Overview
Hydrocortisone, a corticosteroid used in anti-inflammatory and endocrine therapies, exists as a chemically synthesized API. The supply chain for hydrocortisone is concentrated among a handful of major pharmaceutical API manufacturers with expertise in steroid synthesis, quality control, and regulatory compliance.

Major Suppliers of Hydrocortisone

1. BASF SE (Germany)
   As one of the leading global chemical companies, BASF produces pharmaceutical-grade hydrocortisone. Their manufacturing facilities are GMP-compliant, and they cater to clients in Europe, North America, and Asia. BASF emphasizes high purity standards and consistent supply.

2. Hubei Yichang Pharmaceutical Group Co., Ltd. (China)
   A prominent Chinese API producer specializing in steroidal drugs, Yichang offers hydrocortisone with certifications aligning with international pharmaceutical standards. They have expanded capacity to meet global demand amid regional trade growth.

3. Thermo Fisher Scientific
   While primarily known for research supplies, Thermo Fisher collaborates with manufacturing partners to source GMP-grade hydrocortisone for clinical and commercial use. Their extensive distribution network supports supply chain resilience.

4. Sigma-Aldrich (Part of Merck KGaA)
   Sigma supplies pharmaceutical-grade hydrocortisone for research and, in some cases, small-scale manufacturing. Their products comply with USP and EP standards, making them suitable for formulation and lab-scale production.

5. Shandong Xinhua Pharmaceutical Co., Ltd. (China)
   Specializing in steroid hormones, Xinhua produces hydrocortisone with high purity, aligning with pharmaceutical manufacturing expectations, and exports globally, supported by robust quality assurance processes.

Market Dynamics & Considerations

• Regulatory Approvals: Suppliers must possess certifications such as GMP, ISO, USP, or EP to meet global pharmaceutical standards.
• Capacity & Lead Times: Concentration of manufacturing in China and India demands consideration of supply chain risks, especially during global disruptions like pandemics.
• Pricing Strategies: Competitive sourcing may involve balancing cost advantages from Asian suppliers against factors like regulatory compliance and logistics.

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Comparison of Supplier Profiles

Attribute	Glacial Acetic Acid	Hydrocortisone
Major Producing Regions	North America, Europe, China	Europe, China, India
Quality Certifications	ISO, GMP, USP, EP	GMP, ISO, USP, EP
Key Market Segments	Pharmaceuticals, Food, Chemical Industry	Pharmaceuticals, Research, API Manufacturing
Supply Chain Risks	Regional disruptions, Raw material sourcing	Regional concentration, Trade policies
Pricing Factors	Volume, Certification, Logistics	Capacity, Certification, Regional tariffs

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Market Trends & Future Outlook

• Increased Demand for High-Purity Chemicals: Regulatory pressure raises standards, favoring suppliers with validated quality assurance processes.
• Supply Chain Diversification: Pharmaceutical firms are seeking multiple suppliers across different geographies to mitigate risks, especially post-COVID-19.
• Emerging Markets: Chinese and Indian manufacturers continue expanding capacity, offering competitive pricing while improving compliance with international standards.
• Sustainability and Compliance: Increasing emphasis on environmentally sustainable manufacturing practices influences supplier selection.

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Key Takeaways

• Supply Security: Global pharmaceutical companies should establish relationships with diversified suppliers possessing certified high-purity products aligned with regulatory standards.
• Quality Assurance: Ensuring suppliers meet strict GMP, USP, and EP certifications remains paramount, especially for APIs like hydrocortisone intended for injectable or oral formulations.
• Cost Optimization: While Chinese suppliers offer competitive pricing, compliance, logistics, and quality consistency should guide procurement strategies.
• Regulatory Considerations: Suppliers with proven track records in regulatory compliance minimize validation hurdles and expedite market approval processes.
• Operational Resilience: Companies must evaluate regional risks and incorporate supply chain flexibility to maintain uninterrupted production.

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FAQs

1. What are the leading global suppliers of glacial acetic acid for pharmaceutical use?
   Eastman Chemical, Celanese, LyondellBasell, and Chinese manufacturers like Yangzhou Chenhua are prominent suppliers with certified, high-purity products suitable for pharma manufacturing.

2. Which companies are primary producers of hydrocortisone APIs?
   Major producers include BASF (Germany), Hubei Yichang Pharmaceutical (China), and regional suppliers in India and other Asian countries.

3. What certifications should I look for in suppliers of pharmaceutical-grade acetic acid and hydrocortisone?
   Certifications such as GMP, USP, EP, ISO 9001, and cGMP are critical indicators of suitability for pharmaceutical manufacturing.

4. How does regional manufacturing influence supply chain security for these chemicals?
   Concentration of production in China and India offers cost benefits but introduces risks related to geopolitical, trade, and logistical disruptions. Diversification helps mitigate these risks.

5. Are there any emerging markets in the supply chain for these APIs?
   Yes, China and India are expanding capacity for both acetic acid and steroid APIs, contributing to a more competitive and diverse supply landscape.

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References

[1] Eastman Chemical Company. (2022). Product specifications and certifications.
[2] Celanese Corporation. (2022). High-purity acetic acid supply chain overview.
[3] BASF SE. (2022). Pharmaceutical-grade steroid APIs.
[4] Hubei Yichang Pharmaceutical Group. (2022). API manufacturing capabilities.
[5] Market reports and industry analyses from IQVIA, PharmSource, and Chemical Market Analytics.

[Note: Inline citations would be added where specific data points or claims are presented.]

Last updated: July 29, 2025