Bulk Pharmaceutical API Sources for XARTEMIS XR

Bulk Pharmaceutical API Sources for XARTEMIS XR

Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical		2023-05-7C04153
RR Scientific		R6253672
RR Scientific		R6319621

Bulk Active Pharmaceutical Ingredient (API) Sources for XARTEMIS XR

Last updated: August 2, 2025

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Introduction

XARTEMIS XR is a prescription medication combining oxycodone hydrochloride (an opioid analgesic) and acetaminophen (paracetamol), designed for the management of acute pain severe enough to require opioid analgesics. The drug's efficacy and safety heavily depend on the quality and sourcing of its active pharmaceutical ingredients (APIs). Ensuring reliable, high-purity API supply chains is critical for manufacturing, regulatory compliance, and market sustainability.

This report examines the landscape of bulk API sources for XARTEMIS XR, focusing on oxycodone hydrochloride and acetaminophen, highlighting key suppliers, manufacturing considerations, regulatory implications, and industry trends.

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1. Overview of APIs in XARTEMIS XR

XARTEMIS XR contains:

• Oxycodone Hydrochloride: A semi-synthetic opioid derived from thebaine, acting primarily on mu-opioid receptors.
• Acetaminophen: An analgesic and antipyretic, synthesized through complex chemical processes.

The quality of each API determines the drug’s safety profile, bioavailability, and regulatory approval. Consequently, sourcing from reputable suppliers with robust quality assurance processes is essential throughout the pharmaceutical supply chain.

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2. API Sourcing for Oxycodone Hydrochloride

Manufacturers and Suppliers

a. Purdue Pharma and Related Manufacturers

Historically, Purdue Pharma has been a prominent producer of oxycodone, primarily for proprietary formulations. While Purdue's direct API manufacturing capabilities are limited, they source from specialized chemical suppliers adhering to stringent cGMP standards.

b. International API Manufacturers

International API producers, especially in China and India, have become primary sources for oxycodone hydrochloride due to cost efficiencies and manufacturing capacities.

• China:
  Chinese API manufacturers such as Zhejiang Huadong Medicine, Zheijiang Hisun Pharmaceutical, and others have established production facilities compliant with international GMP standards, supplying oxycodone APIs globally. These firms often provide bulk APIs to pharmaceutical companies under contractual manufacturing arrangements.

• India:
  Indian chemical exporters like Sun Pharmaceutical, Dr. Reddy’s Laboratories, and Aurobindo Pharma also produce oxycodone hydrochloride APIs. Their facilities are often inspected and certified by the USFDA or EMA, ensuring compliance with quality standards.

c. US and European Manufacturers

• Chemical & Pharmaceutical Giants:
  Companies like Johnson Matthey and Patheon, with extensive APIs portfolios, supply oxycodone hydrochloride to the North American and European markets. These suppliers usually undergo rigorous prequalification processes by pharmaceutical companies and regulators.

Suppliers Quality & Regulatory Status

API manufacturers supplying oxycodone hydrochloride must comply with cGMP (current Good Manufacturing Practice) standards, ensuring high purity and consistent batch quality. Regulatory bodies like the USFDA, EMA, and Health Canada regularly inspect these facilities. Suppliers with good regulatory standing are preferred for risk mitigation.

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3. API Sourcing for Acetaminophen

Major Producers and Suppliers

a. Global Chemical Companies

• Mitsubishi Tanabe Pharma: A Japanese company manufacturing high-quality acetaminophen (paracetamol) for global markets.

• Huzhou Soda Ash Co., Ltd.: Chinese producer specializing in pharmaceutical-grade acetaminophen, supplying a significant portion of the API market.

• Ming Fai Pharmaceutical: based in India, known for manufacturing pharmaceutical excipients and APIs, including acetaminophen.

b. Regional API Manufacturers

• Teva Pharmaceutical Industries: exports acetaminophen APIs with compliance to international standards.

• BASF and Dow Chemical: Major chemical suppliers, providing acetaminophen intermediates and APIs, often used in both branded and generic formulations.

Quality and Regulatory Certification

Manufacturers of acetaminophen APIs are required to meet pharmacopeial standards (USP, EP, JP). Suppliers approved by major regulatory agencies, with documented cGMP compliance and batch consistency, are preferable.

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4. Industry Trends and Considerations

a. Supply Chain Diversification

Reliance on a limited number of API suppliers poses supply chain risks, such as shortages and regulatory scrutiny. Many pharmaceutical companies diversify sourcing across multiple certified suppliers to mitigate disruptions.

b. Regulatory Scrutiny and Quality Assurance

Global regulators emphasize API quality to prevent contamination and subpar efficacy. Inspections of API manufacturing facilities have intensified, especially in China and India, leading to increased compliance costs but improved safety standards.

c. Cost Dynamics

While sourcing from low-cost regions like China and India offers economic benefits, pressure to ensure compliance and quality hash out long-term sourcing strategies favoring suppliers with robust regulatory track records.

d. Advances in API Production

Innovations include continuous manufacturing, advanced purification techniques, and improved process controls, boosting API quality and manufacturing efficiency.

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5. Regulatory and Legal Aspects of API Sourcing

• Import Regulations:
  APIs like oxycodone are controlled substances, requiring strict licensing. Global API suppliers must adhere to the Drug Enforcement Administration (DEA) regulations for import/export in the US.

• Documentation & Certification:
  Certificates of analysis (CoA), cGMP compliance documentation, and regulatory approvals are mandatory for APIs destined for pharmaceutical manufacturing.

• Traceability & Transparency:
  Increasingly, companies require detailed supply chain transparency, including country of origin, manufacturing processes, and audit reports.

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6. Summary of Major API Source Countries

Country	Key Characteristics	Notable Manufacturers / Suppliers	Regulatory Environment
United States	Limited local API manufacturing; high regulatory standards	Johnson Matthey, Patheon	Stringent, FDA-inspected facilities
India	Major API manufacturing hub, cost-effective	Sun Pharma, Aurobindo, Lupin	WHO-GMP, USFDA, EMA approved
China	Large-scale API production, competitive pricing	Zhejiang Huadong, Huzhou Soda Ash	Increasing regulatory oversight
Europe	High-quality production, specialized suppliers	BASF, Evonik	EU-GMP standards

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7. Conclusion

The sourcing of APIs for XARTEMIS XR requires a strategic assessment of supplier quality, regulatory compliance, production capacity, and geopolitical stability. Predominantly, API supplies originate from India and China, with trusted international suppliers from North America and Europe ensuring high standards. Ensuring rigorous qualification processes and ongoing supplier audits are crucial to maintaining the integrity of the finished product.

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Key Takeaways

• Multiple sourcing channels mitigate supply chain risks for oxycodone hydrochloride and acetaminophen APIs.
• Regulatory compliance and quality certifications are non-negotiable for API suppliers, especially given the controlled status of oxycodone.
• Regional industry trends show a shift toward diversified, compliant suppliers in India and China, balanced with imports from North America and Europe.
• Innovation in API manufacturing enhances quality, safety, and production efficiency.
• Due diligence in supplier qualification, continuous monitoring, and transparent documentation are essential for regulatory approval and market stability.

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FAQs

Q1: Are there alternatives to Chinese and Indian APIs for oxycodone hydrochloride?
A: Yes. European and North American suppliers, such as Johnson Matthey and Patheon, provide APIs with high regulatory compliance, albeit often at higher costs.

Q2: How does API quality impact regulatory approval for XARTEMIS XR?
A: API quality directly affects safety, efficacy, and compliance; substandard APIs can lead to regulatory delays or rejections.

Q3: What regulatory agencies monitor API manufacturing?
A: The primary agencies include the USFDA, EMA (European Medicines Agency), and the WHO for international standards.

Q4: Is API sourcing for controlled substances like oxycodone strictly regulated?
A: Yes. Controlled APIs require special licensing, strict documentation, and adherence to international and local regulations.

Q5: How do supply chain disruptions of APIs affect pharmaceutical manufacturing?
A: Disruptions can cause shortages, increased costs, and potential delays in product availability. Supply chain diversification and strategic stockpiling mitigate these risks.

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References:

[1] US Food & Drug Administration (FDA). “Drug Master Files (DMFs) for APIs.”
[2] European Medicines Agency (EMA). “API Manufacturing and Quality Control.”
[3] World Health Organization (WHO). “Guidelines for the Production and Quality Control of APIs.”
[4] Industry reports on API manufacturing, 2022-2023.