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

Roxicodone Suppliers: What Companies Provide the Drug Substance and Product

Last updated: April 25, 2026

Roxicodone (also spelled roxikodone) is an opioid analgesic active ingredient and branded product in some markets. Supplier availability depends on whether the buyer needs API (drug substance), finished dosage forms (drug product), or both. Public-facing supplier ecosystems for roxicodone are typically narrower than for widely globalized opioids, and many supply chains route through regional distributors and contract manufacturers rather than large multi-market brand owners.

Because “roxicodone” is a prescription opioid, supply status and legality are heavily jurisdiction-specific and frequently handled through authorized distribution networks, regulatory filings, and contract manufacturing.

Which entities typically supply roxicodone to pharma buyers?

Roxicodone supply usually comes from one of four categories:

1. API manufacturers (drug substance)
   • Produce roxicodone as active pharmaceutical ingredient for formulation into tablets, capsules, or oral liquids.
2. Finished-dose manufacturers (drug product)
   • Manufacture the dosage form and package and label it for market distribution.
3. Specialty wholesalers and authorized distributors
   • Source product from manufacturers and supply licensed customers.
4. Contract development and manufacturing organizations (CDMOs/CMOs)
   • Formulate or package under contract using purchased API or API-to-product conversion.

How to interpret supplier lists in roxicodone procurement

A roxicodone “supplier” can mean different roles:

• API supplier: provides the substance used in manufacturing.
• Formulation/finished product supplier: provides manufactured roxicodone tablets/capsules.
• Distributor: sells from inventory under regulated channels.
• CRO/CDMO: provides services but may not sell the API as a commodity.

For R&D or commercial manufacturing, the buyer must match the supply role to the intended use case: registration filing, GMP manufacturing, and market distribution.

Supplier identification: what is actually trackable in public sources

Public sources that can be used to identify candidates are typically:

• Regulatory product labeling (countries where roxicodone is marketed)
• Imported product listings
• Company press releases and product catalogs
• Regulated API listing databases

However, without specifying the target jurisdiction and whether the need is API vs drug product, public supplier identification becomes non-deterministic. Many companies only show listings under local distributors and do not publish global supplier rosters.

Roxicodone supply chain: where it normally sits

Roxicodone is used as an opioid analgesic and is classified under controlled substance regimes in many jurisdictions. Supply chains therefore rely on:

• Licensing and import authorization
• Controlled substance handling
• GMP documentation
• Traceable sourcing from approved manufacturers

These constraints tend to reduce the number of directly identifiable, publicly listed “suppliers” compared with non-controlled APIs.

Actionable procurement structure for roxicodone

For a business decision, supplier diligence for roxicodone should be structured to verify:

• Product form: API vs tablets vs capsules vs oral solution
• GMP status: manufacturing site approval relevant to the buyer’s target market
• Regulatory documentation: DMF/CEP/ASMF where applicable (API) and registration dossiers (product)
• Controlled substance authorization: licensing for transport, storage, and handling
• Quality system: batch release testing and specification conformance

In practice, the most operationally reliable supplier route for roxicodone is often:

• API purchase from an API manufacturer with a controlled substance capable supply chain, then
• CMO formulation and packaging, then
• local authorized distribution in the target country.

What “suppliers” means for investment and R&D diligence

For R&D programs:

• The critical suppliers are the API manufacturer and the CMO for formulation.
• Distributors are secondary unless the program is buying finished product for clinical supply.

For commercial supply:

• The critical suppliers are licensed finished-dose manufacturers and authorized distribution partners.
• API sourcing matters for cost and continuity but is often managed under long-term commercial contracts.

Known market positioning of roxicodone (context for supplier pool)

Roxicodone has been associated with analgesic use under opioid control rules. Public drug identity and controlled substance handling requirements vary by country, affecting which manufacturers and distributors can legally sell and ship.

Key Takeaways

• Roxicodone supply typically concentrates among API manufacturers, finished-dose CMOs, and authorized distributors due to controlled-substance constraints.
• “Supplier” must be defined by role: API, drug product, distribution, or CMO services.
• Publicly identifying named suppliers globally is not reliable without jurisdiction and API vs finished product scope because supply often routes through local authorized networks.
• The most decision-useful procurement path is API manufacturer sourcing + formulation/packaging via GMP CMO + licensed distribution.

FAQs

1) Do roxicodone suppliers usually provide API, finished product, or both?

Most suppliers are organized by role. API supply is handled by drug substance manufacturers, while finished dosing is handled by drug product manufacturers or CMOs. Dual-role suppliers exist but are less common for controlled opioids.

2) What matters more for roxicodone procurement: API supplier or finished-dose manufacturer?

It depends on the program. For formulation and registration, the API supplier and its documentation quality matter first. For commercialization, finished-dose manufacturing and local distribution control matter most.

3) Are roxicodone suppliers the same across countries?

No. Controlled substance authorization and import/export licensing restrict supply by jurisdiction, so the effective supplier roster changes by market.

4) What compliance artifacts should suppliers provide for roxicodone?

Typical requirements include GMP manufacturing information and batch documentation, plus controlled substance handling capability aligned to the buyer’s jurisdictional import and distribution rules.

5) How should a company validate continuity of roxicodone supply?

Through supply agreements with defined manufacturing lead times, batch release controls, and documented ability to ship under regulated controlled-substance logistics.

---

References

[1] FDA. “Controlled Substances.” U.S. Food and Drug Administration. https://www.fda.gov/drugs/controlled-substances.
[2] Drug Enforcement Administration. “Controlled Substances.” U.S. Department of Justice. https://www.dea.gov/drug-information.
[3] ICH. “ICH Q7: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.” International Council for Harmonisation. https://www.ich.org/page/quality-guidelines.
[4] ICH. “ICH Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities).” International Council for Harmonisation. https://www.ich.org/page/quality-guidelines.