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

Oxymorphone Hydrochloride: A Comprehensive Analysis of Suppliers, Market Dynamics, and Regulatory Challenges

The pharmaceutical supply chain for oxymorphone hydrochloride, a potent semi-synthetic opioid analgesic, is shaped by a complex interplay of regulatory oversight, patent litigation, and evolving market demands. This report examines the key suppliers, manufacturing trends, and challenges impacting the availability of this critical pain management drug, drawing on recent regulatory filings, market analyses, and supply chain disruptions.

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Key Suppliers of Oxymorphone Hydrochloride

Aurobindo Pharma USA

Aurobindo Pharma USA is a prominent supplier of oxymorphone hydrochloride tablets, offering 5 mg and 10 mg strengths under NDC codes 13107010301 and 13107010401, respectively[2][12]. The company’s presence in Cardinal Health’s distributor lists highlights its role in the U.S. generics market, particularly for Schedule II controlled substances[2][12]. Aurobindo’s production capabilities are bolstered by its compliance with FDA Good Manufacturing Practices (GMP), ensuring consistent quality for extended-release formulations[9][14].

Camber Pharmaceuticals

Camber Pharmaceuticals supplies oxymorphone hydrochloride tablets under NDC codes 31722092901 (5 mg) and 31722093001 (10 mg)[2][12]. Despite recent discontinuations of certain oxycodone products[5], Camber remains active in the opioid market, leveraging partnerships with distributors like Cardinal Health to maintain availability[12]. The company’s focus on high-volume generic production positions it as a key player amid ongoing shortages[5].

Mallinckrodt Pharmaceuticals

Mallinckrodt, headquartered in Ireland, has historically been a major manufacturer of generic opioids, including oxycodone and oxymorphone[7]. However, the company faced significant legal repercussions, including a $18 million settlement in Colorado for its role in fueling the opioid crisis[7]. While Mallinckrodt’s oxymorphone products are not explicitly detailed in the available data, its extensive distribution network and history of generic drug production underscore its indirect influence on the market[7][15].

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Market Dynamics and Competitive Landscape

Patent Litigation and Settlements

The 2010 settlement between Impax Laboratories (now part of Amneal Pharmaceuticals) and Endo Pharmaceuticals allowed Impax to launch a generic version of Opana® ER (oxymorphone hydrochloride) in 2013[1]. Subsequent renegotiations in 2017 introduced royalty-sharing arrangements, reflecting the competitive pressures in the generic opioid market[3]. These agreements enabled Impax to continue supplying AB-rated generic oxymorphone while Endo phased out its original formulation[3]. Combined sales of Impax’s generic and Endo’s reformulated Opana ER reached $229 million in the twelve months ending March 2017[3].

Global Market Trends

The global oxymorphone hydrochloride market is projected to grow through 2029, driven by demand for pain management solutions and generic substitution[6]. Regional disparities exist: North America dominates production due to robust generics infrastructure, while Asia-Pacific emerges as a cost-competitive manufacturing hub[6][9]. Suppliers like Rusan Pharma (India) and Parand Darou Pharma (Iran) highlight the globalization of API production[9][16].

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Regulatory and Supply Chain Challenges

Counterfeit Products and Safety Alerts

In August 2024, the World Health Organization (WHO) issued an alert for falsified oxymorphone hydrochloride 40 mg tablets contaminated with metonitazene, a potent synthetic opioid[8]. These counterfeit products, detected in Finland, lacked critical identifiers such as barcodes and embossed markings, posing severe overdose risks[8]. The incident underscores vulnerabilities in unregulated supply chains and the need for enhanced vigilance among distributors[8].

Discontinuations and Shortages

Supply instability persists due to discontinuations and manufacturing delays. In Australia, Mundipharma reversed its decision to halt Oxynorm® (oxycodone) capsules, but Oxycodone BNM 10 mg and 20 mg capsules remain in short supply until June 2025[4]. Similarly, U.S. suppliers like Amneal and Rhodes Pharmaceuticals have faced intermittent back orders for oxycodone immediate-release tablets, with partial resolutions expected by mid-2025[5].

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Active Pharmaceutical Ingredient (API) Manufacturers

Veranova and Noramco

Veranova (U.S.A.) and Noramco (U.S.A.) are leading API suppliers, providing high-purity oxymorphone hydrochloride for formulation[9][16]. Their compliance with USDMF (U.S. Drug Master File) standards ensures regulatory adherence for finished-dose manufacturers[13][16].

Rusan Pharma and Parand Darou Pharma

India’s Rusan Pharma and Iran’s Parand Darou Pharma exemplify the shift toward cost-efficient API production in emerging markets[9][16]. These suppliers cater to generic drugmakers seeking to reduce manufacturing costs while meeting WHO-GMP standards[6][14].

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Future Outlook and Strategic Recommendations

The oxymorphone hydrochloride market will likely face continued regulatory scrutiny and supply chain fragmentation. Strategic priorities for stakeholders include:

1. Diversifying API Sourcing: Engaging multiple regional suppliers to mitigate disruption risks[6][9].
2. Investing in Anti-Counterfeiting Technologies: Implementing track-and-trace systems to combat falsified products[8].
3. Advocating for Policy Reforms: Balancing opioid access with public health safeguards to address litigation-driven market exits[3][7].

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Key Takeaways

• Aurobindo Pharma and Camber Pharmaceuticals are critical suppliers of generic oxymorphone hydrochloride in the U.S.
• Patent settlements between generic and branded manufacturers shape market entry timelines[1][3].
• Global API production is increasingly concentrated in India and Iran, raising quality assurance concerns[6][9].
• Counterfeit opioids pose significant public health risks, necessitating stricter supply chain controls[8].

Frequently Asked Questions

1. Which companies currently supply oxymorphone hydrochloride in the U.S.?
Aurobindo Pharma, Camber Pharmaceuticals, and KVK-Tech are active suppliers, though availability varies by strength and formulation[2][5][12].

2. How has patent litigation affected oxymorphone availability?
Settlements, such as the 2017 Impax-Endo agreement, have enabled generic production while delaying competition for branded formulations[3][7].

3. What are the risks of counterfeit oxymorphone products?
Falsified tablets may contain lethal substances like metonitazene, leading to overdose and death[8].

4. Why are there ongoing shortages of opioid analgesics?
Discontinuations (e.g., Mallinckrodt’s exit) and manufacturing delays (e.g., Rhodes Pharmaceuticals) disrupt supply chains[5][7].

5. Which regions dominate oxymorphone API production?
North America and Asia-Pacific lead, with India and Iran emerging as cost-competitive hubs[6][9][16].

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This report synthesizes data from regulatory filings, market analyses, and supply chain disclosures to provide a nuanced understanding of oxymorphone hydrochloride sourcing. Stakeholders must navigate regulatory, ethical, and logistical challenges to ensure sustainable access to this critical therapeutic agent.

References

1. https://investors.amneal.com/news/press-releases/press-release-details/2013/Impax-Laboratories-Launches-Oxymorphone-Hydrochloride-Extended-Release-Tablets/default.aspx
2. https://www.cardinalhealth.com/content/dam/corp/web/documents/spreadsheet/cardinal-health-ny-item-list.pdf
3. https://investors.amneal.com/news/press-releases/press-release-details/2017/Impax-Announces-Settlement-of-Contract-Litigation-on-Opana-ER-Oxymorphone-Hydrochloride-CII-Extended-Release-Tablets/default.aspx
4. https://www.tga.gov.au/safety/shortages/information-about-major-medicine-shortages/about-shortage-and-discontinuation-oral-opioid-products
5. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=926
6. https://www.researchandmarkets.com/reports/4182008/oxymorphone-hydrochloride-cas-357-07-3
7. https://coag.gov/press-releases/8-2-22-2/
8. https://www.who.int/news/item/05-08-2024-medical-product-alert-n-3-2024--falsified-(contaminated)-oxymorphone-hydrochloride-40mg
9. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/oxymorphone-hydrochloride
10. https://www.fda.gov/drugs/information-drug-class/list-affected-prescription-acetaminophen-manufacturers
11. https://www.drugs.com/availability/generic-opana-er.html
12. https://www.cardinalhealth.com/content/dam/corp/web/documents/spreadsheet/cardinal-health-ri-item-list.pdf
13. https://www.pharmacompass.com/active-pharmaceutical-ingredients/oxymorphone-hcl
14. https://www.pharmacompass.com/active-pharmaceutical-ingredients/oxymorphone-hydrochloride
15. https://www.pharmacompass.com/active-pharmaceutical-ingredients/oxycodone-hydrochloride
16. https://www.pharmacompass.com/manufacturers-suppliers-exporters/oxymorphone-hydrochloride