Bulk Pharmaceutical API Sources for ROXICET 5/500

Bulk Pharmaceutical API Sources for ROXICET 5/500

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		HmvD@DATf^Uqej@B@@@
Sigma-Aldrich		A3035_SIAL
Sigma-Aldrich		A5000_SIAL

Bulk Active Pharmaceutical Ingredient (API) Sources for ROXICET 5/500

Last updated: September 10, 2025

Introduction

Roxicet 5/500 combines oxycodone and acetaminophen, serving as a potent analgesic prescribed for moderate to severe pain management. As a Schedule II controlled substance, the procurement, manufacturing, and distribution of its Active Pharmaceutical Ingredient (API)—specifically oxycodone and acetaminophen—are subject to stringent regulations. This analysis explores potential suppliers for these APIs, emphasizing regulatory compliance, quality standards, and market dynamics critical for manufacturers aiming to produce Roxicet 5/500.

Regulatory Landscape of API Sourcing

Sourcing APIs for controlled substances like Roxicet entails navigating a complex regulatory environment governed by agencies such as the U.S. Drug Enforcement Administration (DEA), the Food and Drug Administration (FDA), and equivalent international bodies. Sourcing from compliant suppliers ensures adherence to Good Manufacturing Practices (GMP), vital for product safety, efficacy, and legal distribution.

Key Regulatory Considerations:

• Supplier compliance with cGMP standards.
• Documentation of batch records and quality certifications.
• Secure supply chain management to prevent diversion.
• Approvals for import/export if sourcing internationally.

Primary API Components for Roxicet 5/500

1. Oxycodone Hydrochloride

As the opioid component, oxycodone's sourcing is particularly sensitive due to its high abuse potential and strict regulatory oversight.

Major API Suppliers for Oxycodone:

• Mallinckrodt Pharmaceuticals: A leading global supplier with robust compliance records and extensive manufacturing capacity. Their oxycodone APIs meet rigorous pharmacopeial standards, offering consistent batch quality for pharmaceutical production [1].
• Municipal Chemical and Manufacturing Corporation: Known for GMP-compliant oxycodone APIs, with an emphasis on supply security and regulatory adherence.
• Sun Pharmaceutical Industries Ltd.: Active in generic opioids, providing APIs that conform to international quality standards, including FDA-approved batches.
• Huaian Huanghua Pharmaceutical Co., Ltd.: Chinese supplier with GMP certification, offering competitively priced oxycodone APIs for export, provided regulatory approval is secured.

Supply Chain Considerations:

• Given restrictions on imported controlled substance APIs in many markets, partnerships with suppliers holding DEA registration or equivalent local approval are essential.
• Quality assurance through Certificate of Analysis (CoA), stability reports, and adherence to USP or EP standards.

2. Acetaminophen

The non-opioid component, acetaminophen, has a broader supplier base due to its widespread use in over-the-counter formulations.

Key Suppliers for Acetaminophen:

• BASF SE: Supplies pharmaceutical-grade acetaminophen meeting USP standards, with a well-established distribution network.
• Vishnu Chemicals: Indian manufacturer producing GMP-certified acetaminophen within international specifications.
• Mitsubishi Chemical Corporation: A global producer of high-purity acetaminophen, emphasizing consistency and regulatory compliance.
• Hubei Yitai Pharmaceutical Co., Ltd.: Chinese GMP-certified supplier, offering competitive pricing for pharmaceutical-grade acetaminophen.

Market Dynamics:

• The acetaminophen supply chain benefits from multiple large-scale producers, reducing procurement risk.
• Continuous quality monitoring is vital, particularly for excipient APIs, to mitigate risks of adulteration.

International API Markets and Sourcing Strategies

North American Market

The U.S. relies heavily on domestic manufacturing due to regulatory barriers for controlled substances. Suppliers such as Mallinckrodt and Pfizer dominate oxycodone API production, holding DEA registration and adhering to stringent U.S. cGMP standards.

European Market

European suppliers, including Teva and Sandoz, provide oxycodone APIs compliant with EMA regulations. Importing APIs necessitates thorough documentation and compliance with the EU’s Good Manufacturing Practice guidelines.

Asian Market

Chinese and Indian manufacturers constitute the core of global API supply, offering cost-effective options. Ensuring regulatory compliance mandates rigorous supplier audits and documentation.

Quality Assurance and Compliance

Manufacturers sourcing APIs for Roxicet 5/500 must prioritize suppliers with:

• Certificates of Analysis (CoA) confirming potency, purity, and impurity profiles.
• Good Manufacturing Practice (GMP) certification.
• Data on batch reproducibility.
• Auditable supply chain records.

In addition, the APIs must meet pharmacopeial standards such as USP, EP, or JP specifications. The potential for counterfeit or substandard APIs necessitates rigorous supplier qualification and periodic re-evaluation.

Supply Chain Challenges

The controlled nature of oxycodone APIs disrupts straightforward sourcing, often resulting in:

• Long lead times due to regulatory approvals.
• Limited supplier options owing to licensing restrictions.
• Heightened vigilance against diversion and trafficking risks.

To mitigate these issues, manufacturers build diversified supplier networks and engage in strategic stockpiling, ensuring supply continuity.

Emerging Trends and Future Outlook

As the global opioid landscape adjusts to tighter regulations, manufacturers are exploring:

• Alternative sourcing models, including licensed imports under strict compliance.
• Development of proprietary supply chains aligned with compliance regimes.
• Investing in local API manufacturing capacities in strategic markets.

Furthermore, advancements in synthetic chemistry and process improvements aim to optimize API yield, reduce costs, and ensure consistent quality.

Conclusion

The reliable procurement of oxycodone hydrochloride and acetaminophen APIs for Roxicet 5/500 hinges on strict adherence to regulatory standards and quality assurance. Leading global suppliers—such as Mallinckrodt, Sun Pharma, and BASF—offer compliant APIs suited for pharmaceutical manufacturing in regulated markets. Balancing cost, quality, and regulatory compliance remains central to establishing resilient supply chains capable of supporting the production needs of Roxicet 5/500.

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Key Takeaways

• Regulatory compliance is paramount; sourcing from DEA-registered and GMP-certified suppliers ensures legal and quality adherence.
• Diversification of suppliers reduces supply chain disruptions, especially given regulatory restrictions on controlled substances.
• Rigorous quality testing and documentation are critical to confirm API purity, potency, and compliance with pharmacopeial standards.
• Asian manufacturers offer cost-effective options but require thorough qualification and regulatory approval.
• Future trends favor in-house API manufacturing and process innovations to mitigate supply risks and manage costs.

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FAQs

1. What are the primary challenges in sourcing APIs for Roxicet 5/500?
Regulatory restrictions on controlled substances like oxycodone pose significant barriers, including licensing, import restrictions, and diversion controls. Ensuring supplier compliance with GMP and DEA regulations is essential, as is maintaining supply chain security.

2. Which suppliers are most reputable for oxycodone API?
Leading manufacturers such as Mallinckrodt Pharmaceuticals, Sun Pharmaceutical Industries, and Teva Pharmaceuticals are recognized for producing high-quality, compliant oxycodone APIs, especially for markets like the U.S. and Europe.

3. How does the sourcing of acetaminophen compare to oxycodone?
Acetaminophen has a broader supplier base due to its widespread use in over-the-counter medication, making it easier and less restrictive to source compared to oxycodone. Still, quality and GMP compliance remain critical.

4. Are there international suppliers capable of providing compliant oxycodone API?
Yes. Chinese and Indian manufacturers, such as Huaian Huanghua Pharmaceutical and Vishnu Chemicals, supply oxycodone APIs, provided they possess the necessary certifications and licensing approvals for export to regulated markets.

5. What strategies can manufacturers employ to ensure a stable supply of APIs?
Diversification of supplier relationships, establishing long-term licensing agreements, maintaining strategic inventory reserves, and employing comprehensive supplier audits and qualification procedures are effective strategies to safeguard supply continuity.

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References

[1] U.S. Food and Drug Administration. "Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)." 2022.