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: February 20, 2026

XARTEMIS XR (oxycodone and acetaminophen extended-release tablets) combines oxycodone HCl with acetaminophen. Its API sourcing involves procuring pharmaceutical-grade oxycodone and acetaminophen from approved manufacturers.

Oxycodone API Suppliers

Approved Manufacturers

Company	Location	API Specifications	Regulatory Approvals	Notes
Cephalon (Teva, Teva API)	United States, Israel	GMP, ≥99% purity	FDA, EMA	Primary API source for US market
Sandoz	Switzerland	GMP, ≥99% purity	EMA, FDA	Alternative supply chain
Patheon (Thermo Fisher)	Canada/US	GMP, ≥99% purity	FDA, Health Canada	For global markets
Zhejiang Huahai Pharm.	China	GMP, ≥98% purity	NMPA, FDA	Cost-efficient, regulated by NMPA

Regulatory and Quality Considerations

• API suppliers must hold USP/NF or EP monographs.
• GMP certification is mandatory for global sales.
• Suppliers are subject to periodic audits by regulatory agencies.

Acetaminophen API Suppliers

Approved Manufacturers

Company	Location	API Specifications	Regulatory Approvals	Notes
Mallinckrodt Pharmaceuticals	United States	USP Grade, ≥99% purity	FDA, EMA	Large-scale US supplier
Zhejiang Hisun Pharmaceuticals	China	GMP, ≥99% purity	NMPA, FDA	Cost-effective, regulated by NMPA
Anhui BBCA Pharmaceutical Co.	China	GMP, ≥98% purity	NMPA	Focus on API quality
Solara Active Pharma Science	India	GMP, ≥99% purity	DCGI, USFDA	Supply for global markets

Quality & Certification

• Must meet USP, EP, or JP standards.
• Certificates of analysis (CoA) required.
• Batch-to-batch consistency critical.

Supply Chain and Regulatory Updates

• API sources are primarily from North America, Europe, and Asia.
• China-based manufacturing remains pivotal due to cost advantages.
• Global regulators continually update API manufacturing standards, impacting sourcing decisions.

Market Trends and Risks

• Increased regulatory scrutiny heightens supplier audits.
• Supply chain disruptions from geopolitical tensions affect API availability.
• Shift toward more rigorous traceability protocols.

Key Takeaways

• Most oxycodone APIs for XARTEMIS XR are sourced from North American, European, and Chinese GMP-certified manufacturers.
• Suppliers must meet regulatory standards, including GMP and monograph compliance.
• Cost, quality, and regulatory status determine supplier choice.
• Supply chain stability remains a critical factor amid geopolitical and regulatory developments.

FAQs

1. What are the main regions supplying oxycodone API?
North America, Europe, and China are primary sources, with China scaling due to cost advantages.

2. How do regulatory standards impact API sourcing?
Suppliers must meet GMP standards and obtain approvals from agencies like the FDA and NMPA, affecting eligibility and quality assurance.

3. Are there alternatives if primary suppliers face disruptions?
Yes, secondary suppliers from Switzerland, Canada, India, and China provide backup options.

4. What are common quality benchmarks for API suppliers?
API purity (≥99%), batch consistency, GMP certification, and adherence to pharmacopeial standards are standard benchmarks.

5. How does regulatory scrutiny affect API procurement?
Increased inspections and audits lead suppliers to enhance compliance, potentially leading to supply delays or increased costs.

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References

[1] U.S. Food and Drug Administration. (2022). Current Good Manufacturing Practice (CGMP) Regulations for Drugs: Quality System Approach. https://www.fda.gov.

[2] European Medicines Agency. (2022). Guidelines on the Quality of Active Substances. https://www.ema.europa.eu.

[3] China National Medical Products Administration. (2022). API Regulatory Requirements. https://www.nmpa.gov.cn.

[4] World Health Organization. (2021). WHO Pharmaceutical Recommendations. https://www.who.int.