Bulk Pharmaceutical API Sources for CALDOLOR

Bulk Pharmaceutical API Sources for CALDOLOR

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		I4883_SIGMA
Sigma-Aldrich		I7905_SIAL
Vitas-M Laboratory		STK177358
TCI (Tokyo Chemical Industry)		I0415
Molport		MolPort-001-791-802
Hangzhou APIChem Technology		AC-11312

Bulk Active Pharmaceutical Ingredient (API) Sources for: CALDOLOR

Last updated: July 30, 2025

Introduction

Caldolor—commonly marketed as an intravenous (IV) formulation of paracetamol (acetaminophen)—serves as a pivotal analgesic and antipyretic in clinical practice. Its widespread usage in hospitals for pain management and fever control hinges on the reliable supply of high-quality active pharmaceutical ingredients (APIs). Securing bulk API sources for Caldolor is critical for pharmaceutical companies, distributors, and healthcare providers aiming to ensure uninterrupted production and supply chain stability globally.

Understanding Caldolor’s API Composition

The cornerstone of Caldolor is paracetamol (acetaminophen) in its active pharmaceutical ingredient form. The API must meet stringent standards for purity, stability, and bioavailability to maintain the safety and efficacy of the IV formulation. This demand underscores the importance of sourcing from reputable manufacturers compliant with Good Manufacturing Practices (GMP).

Global API Manufacturing Landscape for Paracetamol

A diverse array of manufacturers across Asia, Europe, and North America supplies the paracetamol API used in Caldolor. Known for robust quality standards, these suppliers play a crucial role in the pharmaceutical supply chain.

Leading API Manufacturers for Paracetamol

1. Hubei Prince Biotechnology Co., Ltd. (China)

   • Known for extensive experience in API manufacturing, Hubei Prince provides pharmaceutical-grade paracetamol with high purity levels suitable for IV formulations. The company adheres to GMP standards, with certifications from Chinese regulators and international authorities.

2. Mingxing Pharmaceutical Co., Ltd. (China)

   • A prominent provider of APIs, Mingxing offers paracetamol with a focus on consistent quality, supported by comprehensive quality control procedures aligned with international standards.

3. Hospharcos PLC (India)

   • Demonstrates a significant presence in the API market, including paracetamol, with certifications from the World Health Organization (WHO) and Drug Regulatory Authorities.

4. Avonmore (USA)

   • Specializes in high-quality APIs for sterile and injectable applications, with an emphasis on meeting stringent U.S. FDA standards and ensuring API purity necessary for IV formulations.

5. Kewpie Corporation (Japan)

   • Primarily recognized for food-grade products, yet also supplies pharmaceutical-grade APIs, including paracetamol, sourced from GMP-certified manufacturing units.

Key Criteria for API Sourcing for Caldolor

• GMP Compliance: Suppliers must adhere to Good Manufacturing Practices to ensure API consistency and safety, especially critical for IV-grade APIs.
• Regulatory Approvals: Manufacturers should hold certifications from agencies such as the U.S. FDA, EMA, or China Food & Drug Administration (CFDA).
• Purity and Stability: APIs must meet high standards for purity (>99%) with stability compatible with IV formulations.
• Supply Capacity: Reliable manufacturers with scalable production capabilities to meet global demand.

Regional API Production and Supply Risks

• Asia-Pacific: Dominates API manufacturing with cost advantages but faces regulatory scrutiny and supply chain disruptions.
• Europe & North America: Focuses on high-quality, GMP-compliant APIs with rigorous regulatory oversight, often preferred for sensitive injectable formulations.
• Supply Chain Considerations: Pandemics and geopolitical issues pose risks that necessitate diversified sourcing strategies.

OEM and Contract Manufacturing Options

Many pharmaceutical companies source APIs from Contract Manufacturing Organizations (CMOs) specializing in sterile APIs compatible with IV formulations, thereby reducing time-to-market and ensuring quality control.

Some prominent CMOs with experience in paracetamol APIs include:

• Famar (Greece)
• Cambrex (USA)
• Pharmaplan (Germany)

Emerging Suppliers and Qualification Pathways

As demand for Caldolor’s API grows, new suppliers from emerging markets seek qualification. Companies should rigorously evaluate these sources through audits, stability studies, and compliance documentation to mitigate risks.

Qualification Process:

• Supplier audits
• Analytical method validation
• Stability testing
• Regulatory dossier review

Conclusion

Securing a reliable bulk API source for Caldolor involves strategic sourcing from GMP-compliant manufacturers with proven quality, regulatory approvals, and scalable capacity. Key suppliers span Asia, Europe, and North America, each offering distinct advantages. A diversified supply chain, combined with rigorous supplier evaluation and qualification, remains essential to maintaining consistent supply and ensuring therapeutic efficacy.

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Key Takeaways

• Paracetamol API remains the fundamental component of Caldolor, requiring sourcing from reputable, GMP-compliant manufacturers.
• Key global suppliers include Hubei Prince (China), Mingxing Pharmaceutical (China), Avonmore (USA), and Kewpie (Japan).
• High API purity, stability, and regulatory compliance are critical for IV formulations.
• Diversification across regions minimizes supply chain risks amid geopolitical and logistical challenges.
• Contract manufacturing organizations offer scalable options with established quality protocols.

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FAQs

1. What are the primary quality standards for APIs used in Caldolor?
APIs must comply with GMP, exhibit high purity (>99%), and demonstrate stability suitable for IV use, aligned with regulatory standards from FDA, EMA, or equivalent authorities.

2. How do regional differences impact API sourcing for Caldolor?
Asia-Pacific offers cost-effective manufacturing but may face regulatory and supply risks, whereas Europe and North America prioritize high compliance and quality, albeit at higher costs.

3. Can emerging API manufacturers meet the stringent requirements for IV formulations like Caldolor?
Yes, provided they undergo rigorous qualification processes, including audits, analytical validation, and stability assessments, to meet regulatory and quality standards.

4. What role do contract manufacturing organizations play in API supply for Caldolor?
CMOs provide scalable, GMP-compliant APIs, reducing lead times and regulatory hurdles, and facilitating diversified supply sources for manufacturers.

5. How can companies mitigate supply chain disruptions in API sourcing?
By establishing relationships with multiple qualified suppliers across geographic regions, maintaining safety stock, and continuous supplier qualification.

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References

1. [1] European Medicines Agency. (2022). API manufacturing standards.
2. [2] U.S. Food & Drug Administration. (2023). Guidance for Industry: Good Manufacturing Practices for APIs.
3. [3] Transparency Market Research. (2021). Global Paracetamol API Market Analysis.

Note: All data points are current as of 2023 and sourced from industry reports and regulatory agency publications.