Bulk Pharmaceutical API Sources for OPANA ER

Bulk Pharmaceutical API Sources for OPANA ER

Vendor	Vendor Homepage	Vendor Sku	API Url
Ambinter		Amb22800582
Smolecule		S618755
AA BLOCKS		AA00CKA3

Bulk Active Pharmaceutical Ingredient (API) Sources for: OPANA ER

Last updated: July 30, 2025

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Introduction

Opana ER, the brand name for oxymorphone extended-release, represents a potent opioid analgesic approved by the U.S. Food and Drug Administration (FDA) for managing severe pain. As a Schedule II controlled substance, oxymorphone’s production and distribution are tightly regulated, with a focus on ensuring high-quality APIs that meet stringent safety and efficacy standards. Identifying reliable bulk API sources for OPANA ER is crucial for pharmaceutical manufacturers, regulatory agencies, and supply chain stakeholders to maintain compliance and ensure consistent drug quality.

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Regulatory Landscape and API Manufacturing Standards

The landscape for sourcing oxymorphone API is shaped by rigorous regulatory oversight to prevent abuse and diversion. The Drug Enforcement Administration (DEA) classifies oxymorphone as a controlled substance, imposing restrictions on its manufacturing and distribution. Manufacturers must comply with Good Manufacturing Practices (GMP) outlined by the FDA, which ensure the API’s chemical purity, stability, and consistency.

High-quality API suppliers typically possess international certifications such as WHO-GMP, ISO 9001, and compliance with U.S. Drug Master Files (DMFs). These certifications serve as indicators of manufacturing quality and regulatory adherence, important for pharmaceutical companies sourcing APIs for commercial production.

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Key Global API Suppliers for Oxymorphone ER

1. Indivior PLC / Indivior Solutions, Inc. (United Kingdom and United States)
Indivior is a leading developer of opioid-based therapies, including oxymorphone API. The company maintains state-of-the-art manufacturing facilities compliant with GMP standards. Indivior supplies high-purity oxymorphone APIs for both branded and generic formulations, with quality certifications suitable for strict regulatory environments.

2. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
A prominent Chinese API manufacturer, Zhejiang Huahai produces various opioid APIs, including oxymorphone, under rigorous GMP standards. The company has obtained multiple certifications and maintains a robust quality management system, serving global markets with reliable supply chains. Their APIs typically undergo comprehensive testing for potency, bioavailability, and impurity profiles aligned with international pharmacopeias.

3. Zhejiang Con Baoxing Pharmaceutical Co., Ltd. (China)
Another Chinese supplier recognized for opioid API production. Con Baoxing emphasizes compliance with international quality standards, offering GMP-certified oxymorphone API. Their production capacity and quality controls align with regulatory expectations, making them a viable source for global pharmaceutical manufacturers.

4. Sun Pharmaceutical Industries Ltd. (India)
Sun Pharma’s API division manufactures a range of opioids, including oxymorphone. Their facilities conform to GMP principles, and they actively participate in regulatory audits, ensuring the APIs meet pharmacopoeial standards suitable for formulation into OPANA ER.

5. Hikma Pharmaceuticals (Jordan)
Hikma produces various controlled substances, including opioid APIs, under strict GMP conditions. Their manufacturing plants in Jordan are inspected regularly by international regulators and adhere to regulatory standards suitable for supply in the US and Europe.

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Emerging and Niche API Manufacturers

Several smaller or regional API producers are also involved in the oxymorphone supply chain, often providing custom synthesis or niche quantities. These include firms with specialized capabilities in controlled substance APIs, typically extending their certification to meet the demands of global pharmaceutical companies.

6. Micro Labs Ltd. (India)
Micro Labs offers GMP-compliant opioids, including oxymorphone API, catering to both generic and branded pharmaceutical markets. Their focus on quality assurance enables them to serve as a secondary API source for established manufacturers.

7. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
This company supplies a wide array of APIs, including controlled substances, with GMP certification and adherence to international pharmacopoeial standards, making them suitable partners for pharmaceutical formulations.

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Sourcing Considerations

When evaluating API sources for OPANA ER, stakeholders should prioritize the following:

• Regulatory Compliance: Confirm that suppliers hold up-to-date certifications (GMP, ISO, DMF filings) and have undergone recent inspections.
• Quality Control: Ensure rigorous testing protocols for purity, potency, and impurity profiles aligned with USP, EP, or JP standards.
• Supply Chain Robustness: Evaluate the manufacturer’s capacity to sustain consistent supply volumes, especially given the surging demand for opioids in pain management and the strict controls surrounding controlled substances.
• Pricing Transparency: Maintain clarity on pricing structures, considering that API costs significantly impact the overall production budget for OPANA ER.
• Traceability and Documentation: Seek transparent documentation of batch records, certificates of analysis, and compliance with export/import regulations.

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Risks and Challenges in API Sourcing

Sourcing oxymorphone API involves navigating challenges related to regulatory scrutiny, counterfeit risks, and geopolitical considerations. The controlled nature of opioids demands meticulous due diligence to prevent supply chain infiltration by illicit actors. Additionally, geopolitical shifts or enforcement changes can impact the availability from certain geographies, notably China and India—key API manufacturing hubs.

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Future Outlook

The global API market for opioids like oxymorphone is poised for continued evolution influenced by regulatory reforms, opioid supply chain reforms, and increasing emphasis on manufacturing transparency. Innovations in synthetic methodologies and process intensification are expected to enhance API quality while potentially reducing costs. Furthermore, the integration of digital supply chain management tools may improve traceability and compliance.

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Key Takeaways

• Reliable API sourcing for OPANA ER hinges on strict adherence to GMP standards and international certifications.
• Major suppliers include Indivior (UK/US), Zhejiang Huahai (China), Sun Pharma (India), Hikma (Jordan), and Micro Labs (India).
• Due diligence should focus on regulatory compliance, quality control, supply stability, and transparency.
• The controlled substance regulation landscape poses ongoing challenges, necessitating comprehensive due diligence and supply chain oversight.
• Future trends include technological advancements in synthesis and supply chain transparency initiatives, impacting API sourcing efficiency and security.

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FAQs

1. What are the primary regulatory considerations when sourcing oxymorphone API?
Manufacturers must ensure suppliers comply with GMP standards, possess appropriate certifications (GMP, DMF), and adhere to DEA regulations governing controlled substances.

2. How does API quality impact the safety and efficacy of OPANA ER?
High-quality API ensures consistent potency, purity, and stability, directly influencing the drug’s safety profile and therapeutic effectiveness while minimizing impurities that could cause adverse effects.

3. What regions are dominant sources of oxymorphone API?
China and India are the primary regions with established production capacity, supported by manufacturers like Zhejiang Huahai, Sun Pharma, and Micro Labs, among others.

4. What risks are associated with international API sourcing for controlled substances?
Risks include regulatory non-compliance, counterfeit APIs, supply disruptions, and geopolitical issues affecting export-import procedures.

5. How can pharmaceutical companies ensure the integrity of their API supply chain?
By conducting thorough supplier audits, verifying certifications, implementing traceability systems, and maintaining longstanding relationships with verified GMP-compliant manufacturers.

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Conclusion

Sourcing high-quality oxymorphone API for OPANA ER manufacturing requires meticulous evaluation of international suppliers' regulatory compliance, quality assurance, and supply stability. While leading firms based in China, India, the US, UK, and Jordan dominate the market, ongoing vigilance in documentation and regulatory adherence remains paramount in mitigating risks and ensuring product integrity. As the global landscape evolves, incorporating technological innovations and supply chain transparency will be vital in maintaining a resilient and compliant API supply.

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References

[1] U.S. Food and Drug Administration (FDA). "Opana ER Approval Summary." 2006.
[2] DEA Diversion Control Division. "Drug Schedules." 2023.
[3] WHO. "Good Manufacturing Practices (GMP) for Pharmaceutical Products." 2020.
[4] Global Pharma Supply Chain Reports, 2022.
[5] International Pharmacopoeia, 2022 Edition.