Bulk Pharmaceutical API Sources for OFIRMEV

Bulk Pharmaceutical API Sources for OFIRMEV

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		HmvD@DATf^Uqej@B@@@
Sigma-Aldrich		A3035_SIAL
Sigma-Aldrich		A5000_SIAL
Sigma-Aldrich		A7085_SIAL
Sigma-Aldrich		A7302_ALDRICH
MP Biomedicals		211385

Bulk Active Pharmaceutical Ingredient (API) Sources for Ofirmev (Acetaminophen)

Last updated: July 28, 2025

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Introduction

Ofirmev, the proprietary formulation of acetaminophen—also widely known as paracetamol—is a globally recognized analgesic and antipyretic used predominantly in hospital settings for pain management and fever reduction. As a critical component in injectable pharmaceutical formulations, the sourcing of high-quality bulk Active Pharmaceutical Ingredient (API) is essential for manufacturers to ensure product safety, efficacy, and regulatory compliance. This article investigates the primary bulk API sources for Ofirmev, analyzing global manufacturing trends, key suppliers, quality standards, and market dynamics.

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Overview of API Manufacturing for Ofirmev

Acetaminophen's API manufacturing process involves synthetic routes that require stringent control of purity, stereochemistry, and contamination levels. The API industry is characterized by a limited number of large-scale producers capable of consistently delivering high-grade pharmaceutical ingredients compliant with international standards such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), and JP (Japanese Pharmacopoeia).

Given Ofirmev's approval as an injectable dosage form, API sources must meet rigorous Good Manufacturing Practice (GMP) protocols. The API's origin influences the drug's quality, safety profile, and regulatory acceptance.

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Major Global API Suppliers for Acetaminophen (Ofirmev)

1. Cellmark and Canada's Industrial API Manufacturers

Canada hosts several API manufacturers specializing in acetaminophen, notably CellMark, Providone, and others, offering GMP-compliant APIs. These suppliers serve major pharmaceutical companies in North America and export globally. Their strengths include reliable supply chains and adherence to stringent quality controls.

2. Chinese API Suppliers

China remains a dominant player in the bulk API market due to its vast manufacturing capacity and cost competitiveness. Notable Chinese API producers such as Zhejiang Pengfeng Pharmaceutical, Jiangsu Hengrui Pharmaceutical, and Shanghai Everbright Pharmaceutical supply acetaminophen APIs conforming to international standards.

However, regulatory variability and quality assurance challenges have prompted some multinational manufacturers to seek verified suppliers with GMP certification. Buyers often employ rigorous audits and batch testing to ensure compliance with international quality benchmarks.

3. Indian API Producers

India is a significant source for acetaminophen API through established companies like Aurobindo Pharma, Sun Pharmaceutical Industries, and Proton Healthcare. These companies have invested heavily in GMP-compliant manufacturing facilities, often validated by global regulatory agencies such as the US FDA and EMA.

Indian producers benefit from cost efficiencies and strong regulatory oversight, making them key suppliers for both domestic use and exports.

4. European API Manufacturers

European companies like Clariant (now part of Siegfried), and certain specialty chemical firms, produce high-purity acetaminophen API for critical applications. While often serving premium markets, their contribution provides a benchmark for quality and compliance.

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Market Dynamics & Sourcing Considerations

• Regulatory Compliance: Buyers prioritize suppliers with GMP certification, batch consistency, and proven regulatory track records. Increasing vigilant inspections by authorities (FDA, EMA) influence supplier selection.

• Quality and Purity Standards: The API must meet strict purity criteria (generally >99.8%) with low residual solvents and endotoxin levels, especially for injectable forms like Ofirmev.

• Cost and Supply Chain Stability: Cost competitiveness is essential; however, supply chain stability, especially amidst geopolitical tensions and global disruptions like COVID-19, has heightened risk mitigation strategies.

• Environmental & Sustainability Factors: Many pharmaceutical firms evaluate suppliers based on sustainable manufacturing practices, reducing environmental impact and ensuring long-term viability.

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Emerging Trends and Future Outlook

• Vertical Integration: Larger pharmaceutical manufacturers increasingly develop in-house API synthesis or secure long-term supply agreements to control quality and reduce dependency on third-party suppliers.

• Supply Chain Diversification: Companies diversify sources across regions to mitigate risks related to regulatory transitions, geopolitical issues, and pandemic-related disruptions.

• Technological Innovation: Continuous improvements in synthesis processes, including greener methods, are influencing API producer competitiveness.

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Regulatory Landscape and API Sourcing

Regulators mandate rigorous pre-and post-market analysis of APIs, with a focus on origin, manufacturing processes, and quality assurance. suppliers must comply with global standards, which influence procurement decisions for Ofirmev formulations.

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Conclusion

The bulk API sourcing landscape for Ofirmev's active pharmaceutical ingredient reveals a diversified global supply chain, predominantly involving Chinese, Indian, North American, and European manufacturers. Ensuring quality, regulatory compliance, and supply chain resilience remains paramount for pharmaceutical companies. As the market evolves, suppliers that demonstrate technological innovation, sustainability, and adherence to stringent quality standards will secure strategic positions.

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Key Takeaways

• Diverse Global Suppliers: Key API sources include Chinese, Indian, North American, and European manufacturers, with varying strengths in cost, quality, and regulatory compliance.
• Regulatory and Quality Standards: Compliance with GMP and international pharmacopoeias is essential, especially for injectable formulations like Ofirmev.
• Supply Chain Resilience: Diversification and long-term agreements mitigate risks amid geopolitical and global health disruptions.
• Emerging Trends: Focus on sustainability and technological innovation influences future API sourcing strategies.
• Strategic Procurement: Companies prioritize validated suppliers with proven quality track records and supply stability for critical APIs like acetaminophen.

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FAQs

1. What are the leading countries supplying acetaminophen API for Ofirmev?
The primary sources include China, India, North America (Canada and the USA), and Europe, notably with Chinese and Indian being the most cost-competitive.

2. How do regulatory standards influence API sourcing for injectable drugs like Ofirmev?
Sourcing decisions hinge on suppliers' compliance with GMP, USP, EP, and other regional standards. Regulators conduct inspections to verify manufacturing practices, impacting approval and market access.

3. What are the quality benchmarks for acetaminophen API used in injectables?
Purity levels exceeding 99.8%, low residual solvents, endotoxin levels suitable for parenteral use, and consistent batch-to-batch quality are essential.

4. Is there a trend toward in-house API manufacturing for Ofirmev?
While some manufacturers develop in-house capabilities to improve control over quality and supply, many rely on trusted third-party suppliers, especially from Asia, due to cost advantages.

5. How does supply chain diversification benefit API sourcing for Ofirmev?
It reduces dependency on a single region or supplier, mitigates risks from geopolitical tensions, natural disasters, and pandemics, and enhances overall supply stability.

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References

[1] U.S. Pharmacopeia (USP). Dispensatory and General Chapters.
[2] European Pharmacopoeia (EP). Monographs and standards for API quality.
[3] ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
[4] Industry reports on global API market and sourcing trends (e.g., IQVIA, Global Market Insights).
[5] Regulatory agency publications and supplier audit reports.

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Note: While specific supplier names are publicly available, detailed proprietary supply agreements are confidential. This overview provides a high-level understanding aligned with current industry practices.