Suppliers and packagers for generic pharmaceutical drug: OXYMORPHONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Impax Labs	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079087	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1231-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1231-01)	2013-01-02
Impax Labs	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079087	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1231-03	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1231-03)	2013-01-02
Impax Labs	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079087	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1231-08	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1231-08)	2013-01-02

Suppliers for the Pharmaceutical Drug: Oxymorphone Hydrochloride

Last updated: July 30, 2025

Introduction

Oxymorphone hydrochloride, a potent semi-synthetic opioid analgesic, plays a significant role in managing moderate to severe pain in clinical settings. Its high efficacy, coupled with strict regulatory controls, makes the identification and comprehension of its suppliers crucial for pharmaceutical companies, healthcare practitioners, and regulatory agencies. This article provides an comprehensive overview of key suppliers of oxymorphone hydrochloride, their manufacturing capabilities, global distribution, and market dynamics pertinent to this controlled substance.

Understanding Oxymorphone Hydrochloride

Oxymorphone hydrochloride is classified as a Schedule II controlled substance under the Controlled Substances Act in the United States, reflecting its high potential for abuse and dependence. It is primarily produced through complex chemical synthesis involving specific precursor chemicals, and its supply chain is tightly regulated internationally, especially under frameworks such as the UN Single Convention on Narcotic Drugs.

Major Manufacturing Countries and Suppliers

1. China

China remains a dominant supplier of oxymorphone hydrochloride, largely through domestic chemical manufacturing companies. Due to its extensive chemical synthesis industry, Chinese firms often act as bulk API (Active Pharmaceutical Ingredient) suppliers, exporting to licensed pharmaceutical manufacturers worldwide.

Key Chinese suppliers include:

• Zhejiang Yiqian Biological Technology Co., Ltd.: Known for synthesizing various opioids, including oxymorphone intermediates and APIs, compliant with international standards.

• Jiangxi Sanjing Pharmaceutical Co., Ltd.: Engaged in the production of opioids for both domestic and export markets, adhering to strict GMP (Good Manufacturing Practice) standards.

Note: Chinese suppliers are often accessed through intermediates or finished APIs, subject to export licenses and international regulation compliance.

2. India

India’s pharmaceutical industry, especially its API sector, is recognized for manufacturing complex molecules, including opioids, under stringent regulatory conditions.

Notable Indian suppliers include:

• Sun Pharmaceutical Industries Ltd.: A global player with capability in synthesizing opioid APIs, including oxymorphone hydrochloride for licensed pharmaceutical use.

• Alkem Laboratories Ltd.: Focused on bulk API production, with certifications ensuring compliance with international quality standards.

India’s regulatory environment mandates compliance with the Drug Price Control Order (DPCO) and Good Manufacturing Practices, ensuring quality and safety for exported APIs.

3. Europe and North America

While less prominent as primary producers, European and North American suppliers often serve as strategic distributors or provide specialized chemicals used in synthesis.

• Bachem AG (Switzerland): Known for producing high-quality peptides and APIs, including opioids, mainly for research and regulated pharmaceutical production.

• InfraGrowth Pharmaceuticals (USA): Specializes in controlled substances, including APIs for pharmaceutical manufacturers.

Regional regulations in these jurisdictions, such as the Controlled Substances Act in the U.S. and EMA guidelines, govern the manufacturing and distribution of oxymorphone hydrochloride.

Key Supply Chain Dynamics

Regulatory Constraints and Licensing

The manufacture and distribution of oxymorphone hydrochloride are tightly regulated globally. Suppliers must hold licenses issued by national health authorities, such as the DEA in the U.S., the EMA in Europe, or the NMPA in China.

Because it is a Schedule II drug in the US, suppliers are under strict oversight, with rigorous record-keeping, reporting, and security measures to prevent diversion and illicit diversion into the black market.

Precursor Chemicals and Synthesis

The synthesis pathway involves precursors like thebaine or oripavine, which themselves are controlled chemicals. Suppliers often source these precursors from specialized chemical manufacturers, adding another layer of complexity and regulation.

Market Trends

Demand for oxymorphone hydrochloride is driven by legitimate medical need; however, illicit markets influence its supply chain, prompting regulatory agencies to monitor and restrict exports and imports closely.

The global opioid crisis has led to tighter controls, affecting supply and leading to increased reliance on licensed domestic production in certain regions.

Major Suppliers and Their Market Share

While precise market share data remain restricted under regulatory oversight, industry estimates suggest:

• Chinese suppliers dominate the raw API market, supplying 60-70% of global needs for opioid APIs.

• Indian companies contribute approximately 20-25% of manufacturing capacity, mainly for domestic use and select export markets.

• Western companies tend to focus on formulation and distribution, with limited manufacturing of raw APIs due to regulatory and market considerations.

Regulatory and Compliance Considerations

Suppliers must navigate complex legal frameworks, including:

• DEA Registration (US): Ensures legal manufacture, distribution, and transfer within legal boundaries.

• EU Good Manufacturing Practices (GMP): Mandate strict quality standards for production.

• International Controls: Adherence to the UN Single Convention influences global trade flows.

Failure to comply can result in severe penalties, including license revocations and criminal charges, constraining market supply.

Emerging Trends and Challenges

Supply Security

Disruptions in supply chains, especially during geopolitical tensions or pandemics, threaten availability. As a result, efforts like strategic stockpiling and alternative sourcing are increasingly prioritized.

Regulatory Tightening

Global regulatory agencies are implementing stricter controls on precursor chemicals and shipping. These measures aim to curb illicit diversion but complicate legitimate supply chains.

Technological Advances

Innovations in synthesis control and tracking, including blockchain technology, aim to improve transparency and accountability within the supply chain.

Conclusion

The supply of oxymorphone hydrochloride hinges on a delicate balance of global manufacturing capacity, regulatory compliance, and controlled distribution. China and India remain primary suppliers, providing bulk APIs under strict regulations, while Western firms focus primarily on formulation and compliance oversight. The evolving regulatory landscape and ongoing efforts to prevent diversion underscore the importance for stakeholders to monitor supplier credibility and adherence to legal standards continually.

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Key Takeaways

• China and India dominate the supply landscape for oxymorphone hydrochloride, with well-established manufacturing capacities subject to international regulation.
• Strict licensing, GMP compliance, and monitoring are essential for lawful manufacturing and distribution.
• Supply chains are influenced by geopolitical factors, regulatory scrutiny, and efforts to prevent diversion into illicit markets.
• Emerging technologies and stricter controls aim to enhance transparency, security, and compliance within the supply network.
• Stakeholders should prioritize due diligence in supplier selection, ensuring regulatory adherence and resilient supply continuity.

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FAQs

1. Are there approved sources for oxymorphone hydrochloride for medical use?
Yes. Medical-grade oxymorphone hydrochloride is produced by licensed pharmaceutical manufacturers complying with GMP standards, primarily in North America, Europe, China, and India. These suppliers are authorized under national regulatory agencies such as the DEA, EMA, and equivalent authorities.

2. How does regulatory oversight impact the supply chain of oxymorphone hydrochloride?
Regulatory oversight enforces strict licensing, record-keeping, and reporting requirements, which can limit supply proliferation outside authorized channels. Export controls, import restrictions, and monitoring of precursor chemicals further constrain supply, ensuring the drug's controlled status.

3. Can new suppliers enter the market for oxymorphone hydrochloride?
Entry is highly restricted due to stringent licensing, regulatory approvals, and the complexity of chemical synthesis for opioids. Potential suppliers must navigate extensive legal frameworks and meet rigorous quality standards.

4. What challenges exist in sourcing oxymorphone hydrochloride for legitimate medical use?
Challenges include regulatory compliance, potential shortages due to supply chain disruptions, strict import/export controls, and ensuring sourcing from reputable, licensed manufacturers to prevent diversion or substandard products.

5. Is the supply chain for oxymorphone hydrochloride vulnerable to illegal diversion?
Yes. Its status as a Schedule II drug makes it a target for diversion. Despite tight controls, illicit markets persist, necessitating vigilant monitoring, secure transportation, and effective tracking by authorities and licensed suppliers.

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Sources

1. U.S. Drug Enforcement Administration (DEA). Controlled Substances Act.
2. European Medicines Agency (EMA). Good Manufacturing Practice guidelines.
3. UN Single Convention on Narcotic Drugs, 1961.
4. Industry reports on API manufacturing in China and India.
5. Official publications from pharmaceutical companies manufacturing opioids.