Suppliers and packagers for roxicodone

roxicodone

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Specgx Llc	ROXICODONE	oxycodone hydrochloride	TABLET;ORAL	021011	NDA	SpecGx LLC	23635-581-10	100 TABLET in 1 BOTTLE, PLASTIC (23635-581-10)	2000-08-31
Specgx Llc	ROXICODONE	oxycodone hydrochloride	TABLET;ORAL	021011	NDA	SpecGx LLC	23635-582-10	100 TABLET in 1 BOTTLE, PLASTIC (23635-582-10)	2000-08-31

Suppliers for the Pharmaceutical Drug: Roxicodone

Last updated: August 1, 2025

Overview of Roxicodone

Roxicodone is a brand name for oxycodone hydrochloride, a potent opioid analgesic used primarily for moderate to severe pain management. As a controlled substance, oxycodone’s manufacturing, distribution, and sale are highly regulated. Roxicodone’s active ingredient, oxycodone, is synthesized through complex chemical processes, with production controlled by licensed pharmaceutical manufacturers approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA).

The primary suppliers of Roxicodone are large pharmaceutical companies that produce oxycodone under strict Good Manufacturing Practice (GMP) standards, while numerous generic manufacturers also produce oxycodone formulations. The landscape of suppliers is influenced by regulatory compliance, geographic location, and market demand, particularly given the opioid crisis and regulatory scrutiny.

Key Manufacturers and Suppliers of Roxicodone

1. Purdue Pharma (Historical)

Historically, Purdue Pharma was the original manufacturer of Roxicodone, holding patent rights and supplying the drug globally. Purdue's role in the manufacturing and distribution of Roxicodone was significant until the company faced substantial legal and regulatory actions related to its role in the opioid epidemic. Purdue Pharma's manufacturing facilities produced Roxicodone in accordance with FDA regulations, but the company filed for bankruptcy in 2019 amid numerous lawsuits. As of recent, Purdue’s rights to Roxicodone are largely transferred under bankruptcy settlement agreements, with production possibly shifted to successor entities or licensees.

2. Generic Pharmaceutical Manufacturers

The majority of Roxicodone prescriptions are now filled with generic oxycodone formulations produced by multiple approved manufacturers:

• Teva Pharmaceuticals
  A leading global generic drug manufacturer, Teva supplies oxycodone extended-release and immediate-release formulations to various markets worldwide. Teva’s manufacturing plants are FDA-approved, adhering to strict standards.

• Amneal Pharmaceuticals
  Known for producing both branded and generic opioids, Amneal supplies oxycodone under various labels, including unbranded generics. Their facilities are FDA-compliant, ensuring consistent quality.

• Actavis (part of Teva)
  Actavis, now a subsidiary of Teva, also produces oxycodone formulations, contributing significantly to the generic supply chain.

• Mylan (now part of Viatris)
  Mylan has historically supplied oxycodone products, with manufacturing facilities regulated by the FDA, although its role has shifted after mergers and restructuring.

• Sandoz (Novartis division)
  Sandoz produces generic oxycodone products, distributed across several markets, with manufacturing adhering to GMP standards.

• Lupin Pharmaceuticals
  An India-based company, Lupin produces generic oxycodone formulations distributed primarily in emerging markets.

• Hikma Pharmaceuticals
  Based in Jordan, Hikma manufactures opioids including oxycodone for multiple global markets, complying with local and international GMP standards.

3. Contract Manufacturing Organizations (CMOs)

Some companies outsource production to CMOs with specialized capabilities in opioid manufacturing, often under strict confidentiality and regulatory oversight. These CMOs may produce oxycodone active pharmaceutical ingredient (API) or finished dosage forms for other pharmaceutical firms.

4. Raw Material Suppliers for Oxycodone API

The supply chain begins with raw materials, including chemicals like thebaine and codeine derivatives, which are sourced from:

• Mundipharma
  A key supplier of heparin and thebaine, Mundipharma is involved in the complex extraction and conversion processes to produce oxycodone API.

• Chemical intermediates producers (various global chemical companies)
  These suppliers provide precursors and intermediates essential to oxycodone synthesis, often sourced from countries like China, India, and Europe.

5. Regulatory and Distribution Channels

Due to its controlled status, Roxicodone’s distribution is tightly regulated via serialization, licensing, and strict supply chain monitoring systems. The Drug Enforcement Administration (DEA) in the U.S. issues quotas for oxycodone production to limit diversion, making the regulatory environment a critical factor for suppliers.

Market Dynamics and Supply Chain Challenges

The oxycodone supply chain faces significant pressures from regulatory measures aimed at curbing misuse and diversion. Increased scrutiny has led to:

• Reduction in the number of licenced manufacturers, primarily large, established firms.
• Intensified compliance requirements, including serialization and track-and-trace systems.
• Supply shortages driven by heightened regulatory barriers, manufacturing disruptions, or lawsuits.

Despite these challenges, large, well-established pharmaceutical firms remain the primary suppliers, given the complexity of manufacturing and regulatory compliance required for oxycodone production.

Global Supply and Distribution Networks

While the majority of Roxicodone is supplied in North America, particularly the U.S., other markets include Europe, Latin America, and parts of Asia. Global suppliers often collaborate with licensed distributors and pharmacies, which impose strict controls over dispensing.

In the U.S., the Drug Supply Chain Security Act (DSCSA) mandates enhanced tracking, which impacts the distribution channels and supply chain integrity for Roxicodone.

Regulatory Considerations

Manufacturers and suppliers must navigate rigorous regulatory environments:

• FDA approval and compliance for manufacturing processes.
• DEA scheduling as a Schedule II controlled substance.
• International regulations, including EMA standards in Europe and local authorities elsewhere.

Compliance is essential not only to maintain manufacturing licenses but also to prevent shortages and illicit diversion.

Conclusion: Navigating the Roxicodone Supply Landscape

The landscape for Roxicodone suppliers is predominantly characterized by large, compliant pharmaceutical companies capable of navigating rigorous regulatory frameworks. While original manufacturer Purdue Pharma has largely exited the market associated with Roxicodone, a broad array of generic manufacturers like Teva, Amneal, and Sandoz continue to supply oxycodone formulations globally. The supply chain remains complex, heavily regulated, and susceptible to external pressures such as regulation, litigation, and manufacturing challenges.

Key Takeaways

• The primary suppliers of Roxicodone are large, FDA-approved generic manufacturers such as Teva and Amneal.
• Purdue Pharma historically supplied Roxicodone but has exited the market due to legal issues.
• The supply chain includes raw material suppliers, API producers, and contract manufacturers, all adhering to strict GMP standards.
• Regulatory frameworks and anti-diversion measures significantly influence supply chain dynamics.
• Despite market challenges, established pharmaceutical companies maintain dominant roles as suppliers of oxycodone products.

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FAQs

1. Who are the main authorized suppliers of Roxicodone in the U.S.?
Major authorized suppliers include Teva Pharmaceuticals, Amneal Pharmaceuticals, and Sandoz, all of which produce FDA-approved generic oxycodone formulations.

2. Is Purdue Pharma still manufacturing Roxicodone?
No. Purdue Pharma ceased manufacturing Roxicodone following bankruptcy and legal settlements. The rights and production responsibilities are now managed by successor entities or licensed manufacturers.

3. How can I verify the legitimacy of a Roxicodone supplier?
Verify suppliers through FDA registration and approval, checking licensing and serialization information, and ensuring compliance with local regulatory authorities.

4. Are there alternative suppliers for oxycodone outside the U.S.?
Yes. Companies like Lupin and Hikma produce oxycodone formulations for international markets, subject to local regulatory approvals.

5. What role do raw material suppliers play in the oxycodone supply chain?
They provide the chemical precursors like thebaine necessary for API synthesis. Their reliability and compliance impact the overall quality and security of oxycodone production.

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Sources

1. U.S. Food and Drug Administration (FDA). FDA Drug Approvals and Registrations
2. Drug Enforcement Administration (DEA). Controlled Substances Listings
3. Purdue Pharma. Official statements and legal filings.
4. Pharmaceutical industry reports on generic drug manufacturing.
5. World Health Organization. Guidelines on opioid production and regulation.