Bulk Pharmaceutical API Sources for HYDROCORTISONE AND ACETIC ACID

Bulk Pharmaceutical API Sources for HYDROCORTISONE AND ACETIC ACID

Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical		2023-05-7C05070
RR Scientific		R6390166

Bulk Active Pharmaceutical Ingredient (API) Sources for Hydrocortisone and Acetic Acid

Last updated: July 30, 2025

Introduction

The procurement of high-quality Active Pharmaceutical Ingredients (APIs) is critical for pharmaceutical manufacturers to ensure drug efficacy, safety, and regulatory compliance. Among widely used APIs, hydrocortisone and acetic acid occupy significant roles across numerous therapeutic and industrial applications. Hydrocortisone, a corticosteroid, treats inflammatory conditions, while acetic acid finds extensive use both medicinally and industrially. This report provides an exhaustive overview of reputable sources for bulk APIs of hydrocortisone and acetic acid, focusing on global manufacturers, regional suppliers, and key considerations for sourcing.

Hydrocortisone API: Overview and Global Suppliers

Chemical Profile and Market Significance

Hydrocortisone (C₂₄H₃₈O₁₂) is a synthetic corticosteroid modeled after cortisol, naturally secreted by the adrenal cortex. It exerts anti-inflammatory and immunosuppressive effects, pivotal in managing conditions like Addison’s disease, eczema, and allergic reactions.

The global demand for hydrocortisone API hinges on its therapeutic prominence, regulatory approvals, and manufacturing capacity. As of 2023, suppliers range from established international pharmaceutical API producers to emerging regional manufacturers.

Major Suppliers and Manufacturing Countries

1. China

China leads global production, with numerous WHO-GMP certified API manufacturers supplying hydrocortisone in bulk. Notable companies include:

• Huangshi Yaojie Pharmaceutical Co. Ltd.: Supplies high-purity hydrocortisone with competitive pricing.
• Zhejiang Xinan Pharmaceutical Co. Ltd.: Offers comprehensive API manufacturing solutions, including hydrocortisone.
• Kezhou Hengxin Pharmaceutical Co. Ltd.: Known for robust compliance and quality standards.

Regulatory and quality considerations: Chinese suppliers with ISO, cGMP, and other certifications are preferred, given the variable landscape of quality assurance.

2. India

India's pharmaceutical landscape features multiple WHO-GMP and US-FDA-approved manufacturers:

• Pharmacia Fine Chemicals: A prominent supplier with extensive experience in corticosteroids.
• Aarti Drugs Ltd.: Offers hydrocortisone API conforming to international standards.
• Siddharth Pharmaceuticals: Emerging supplier with reliable quality assurance.

Indian API manufacturers benefit from competitive pricing and well-established supply chains, with many holding stringent regulatory approvals.

3. Europe & North America

While less prominent in volume, European and North American producers often supply high-grade APIs with strict regulatory compliance:

• BASF (Germany): Known for high-purity APIs, including hydrocortisone, serving the global market.
• EUROLAB (France): Specializes in corticosteroid APIs with high regulatory standards.
• Fresenius Kabi (Germany): Supplies APIs and finished formulations, including hydrocortisone, primarily for clinical and hospital use.

Emerging Sources and Specialized Suppliers

• SuZhou Zhoulong Pharmaceutical (China): Focuses on semi-synthetic corticosteroids, including hydrocortisone.
• Hubei Biocause Pharmaceutical (China): An emerging player with scalable API production.

Regulatory and Quality Accreditations

Potential buyers should prioritize suppliers with:

• cGMP compliance
• ISO certifications
• Documentation on batch consistency
• Certificate of Analysis (CoA) and stability data

Supply Chain Dynamics

Hydrocortisone API supply is influenced by:

• Raw material availability (notably steroidal intermediates)
• Geopolitical factors affecting trade
• Regulatory changes regarding corticosteroid manufacturing

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Acetic Acid API: Overview and Global Suppliers

Chemical Profile and Market Significance

Acetic acid (CH₃COOH) is a key industrial chemical and a pharmaceutical excipient with applications in synthesizing acetates, acetic anhydride, and other derivatives. Medicinally, it's used in certain formulations, disinfectants, and as a pH adjuster.

Major Suppliers and Manufacturing Countries

1. China

China dominates acetic acid production, with numerous facilities producing both glacial and dilute forms:

• Jiangsu Sopo Chemical: One of the world's largest producers of glacial acetic acid.
• Henan Shenli Chemical Co. Ltd.: Offers highly pure acetic acid suitable for pharmaceutical needs.
• Shanxi Sanwei Group: Supplies bulk quantities with competitive pricing.

Quality & Certification: Suppliers with ISO 9001, ISO 14001, and pharmacopeial compliance are preferred for pharmaceutical-grade acetic acid.

2. United States

US producers focus on high purity and specialty grades:

• Eastman Chemical Company: Supplies acetates and acetic acid with rigorous quality standards.
• Dow Chemical Company: Offers high-grade acetic acid suitable for pharmaceutical and industrial applications.
• LyondellBasell: Provides acetic acid with high purity and consistent quality.

3. Europe

European manufacturers serve niche markets with high-quality specifications:

• INEOS Enterprises (UK): Supplies acetic acid for pharmaceutical-grade applications.
• Celanese (Germany): Produces acetates and acetic acid adhering to strict EU standards.

Other Notable Suppliers

• Jiangsu Sopo Chemical Co. Ltd. (China): Leading manufacturer of glacial acetic acid.
• Lotte Chemical (South Korea): Offers industrial and pharmaceutical grades.

Regulatory and Quality Considerations

Buyers should verify:

• Certificate of Analysis reflecting purity (>99.85% for pharmaceutical grade)
• Certifications (ISO, cGMP)
• Proper documentation for registration approval

Supply Chain & Logistics

Factors influencing sourcing include:

• Regional production capacity
• Raw material prices (methanol-based synthesis)
• Tariffs and trade policies affecting supply and pricing

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Sourcing Considerations for Hydrocortisone and Acetic Acid APIs

Quality & Regulatory Compliance

Affirm API suppliers' certifications, including cGMP, ISO, and pharmacopoeial standards. Incorporate rigorous batch validation processes and analytical testing.

Pricing & Lead Times

Chinese and Indian suppliers generally offer competitive pricing with variable lead times; European and North American suppliers provide higher assurance but at elevated costs.

Long-term Supply Security

Establish relationships with multiple certified suppliers to mitigate risks of supply disruptions, especially amid geopolitical fluctuations or raw material shortages.

Sustainability & Ethical Sourcing

Prioritize companies with transparent manufacturing practices, environmental compliance, and adherence to ethical standards.

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Key Takeaways

• Global leaders in hydrocortisone API manufacturing include Chinese companies like Huangshi Yaojie Pharmaceutical and Indian firms such as Pharmacia Fine Chemicals.
• European and North American companies like BASF and Fresenius Kabi provide high-quality APIs for specialized markets.
• Chinese producers dominate acetic acid supply, offering both industrial and pharmaceutical grades, with Jiangsu Sopo Chemical as a key manufacturer.
• Regulatory compliance—certifications such as cGMP, ISO, and pharmacopeial standards—remains critical in API sourcing decisions.
• Supply chain resilience demands diversification of suppliers, especially amid geopolitical and trade uncertainties.

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FAQs

Q1: How can I ensure the quality of hydrocortisone API from Chinese suppliers?
A1: Verify certifications such as cGMP and ISO, request comprehensive Certificates of Analysis, and conduct on-site audits or third-party quality assessments before establishing long-term contracts.

Q2: Are Indian APIs for hydrocortisone suitable for global markets?
A2: Yes, many Indian API manufacturers are FDA-approved and certified ISO-GMP compliant, making them suitable for global regulatory submissions, provided proper validation and documentation are obtained.

Q3: What are the main quality differences between APIs from China, India, and Europe?
A3: European APIs typically adhere to stricter standards with more extensive regulatory oversight. Chinese and Indian APIs can meet international quality benchmarks but require careful supplier validation to ensure compliance.

Q4: What regulatory considerations affect sourcing acetic acid API for pharmaceutical use?
A4: Ensure the supplier provides pharmacopeial-grade acetic acid (e.g., USP, EP, BP standards), with appropriate documentation, and compliance with local drug regulatory authorities.

Q5: How do geopolitical factors impact the sourcing of these APIs?
A5: Trade policies, tariffs, and geopolitical tensions can disrupt supply chains, leading to adjustments in sourcing strategies, such as diversifying supplier bases or increasing inventory stockpiles.

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References

1. [1] Global Pharmaceutical API Market Analysis, MarketsandMarkets, 2023.
2. [2] U.S. Food and Drug Administration (FDA) Guidance on API Manufacturing Practices, 2022.
3. [3] World Health Organization (WHO) Quality Assurance of Pharmaceutical Products, 2021.
4. [4] Chinese National Medical Products Administration (NMPA) API Certification Standards, 2022.
5. [5] European Pharmacopoeia, Monographs on Acetic Acid, 2022.