Last updated: April 25, 2026
Who are the known suppliers/manufacturers of Oxymorphone Hydrochloride?
Oxymorphone hydrochloride supply in the market is dominated by (1) originators and branded supply chains, (2) generic API and finished-dose manufacturers, and (3) contract manufacturers producing controlled-substance APIs and intermediates under DEA and applicable GMP regimes.
Which suppliers are tied to branded or finished-dose oxymorphone hydrochloride products?
The US oxymorphone hydrochloride market is historically anchored by branded and authorized generic products. The practical “supplier” set for finished dosage forms is typically the marketing authorization holder plus the CMO/API chain behind it. These entities include:
- Endo Pharmaceuticals (branded supply chain historically associated with oxymorphone products in the US)
- Teva (authorized generics and supply chains historically present for oxymorphone-containing products)
Which suppliers are active in generic oxymorphone hydrochloride finished dosage forms?
Generic finished-dose supply is usually supported by multiple manufacturers across strengths and dosage types. Commonly observed participants in US generic opioid supply chains include:
- Lupin
- Amneal
- Mylan / Viatris (legacy supplier footprints for multiple opioid generics, with ownership and manufacturing networks consolidated over time)
Which API and CMO suppliers support oxymorphone hydrochloride manufacturing?
Oxymorphone hydrochloride is a controlled opioid. API supply is generally produced by manufacturers with DEA registration and relevant GMP compliance for opioid substances and intermediates. In the market, API and intermediate supply typically comes from:
- US-based controlled substance API manufacturers (DEA-registered)
- Qualified CMOs (often global) producing opioid APIs for branded and generic finished-dose programs
The exact API supplier for a specific NDA/ANDA product is not uniform and is governed by procurement contracts, site qualification, and API life-cycle management. For commercial due diligence, the operational approach is to map the ANDA holder to its listed manufacturing sites (drug product and API) and confirm current production via latest product labeling and regulatory filings.
What is the most actionable way to identify the supplier for a specific product SKU?
For procurement, R&D sourcing, or investment diligence, use this deterministic mapping logic:
- Select the specific dosage form and strength (oxymorphone hydrochloride immediate-release vs extended-release; strength in mg).
- Identify the ANDA holder (or NDA holder) for that SKU.
- Extract the current manufacturing information from the most recent regulatory listing:
- drug product manufacturing site(s)
- packaging site(s)
- labeler and related operations
- Confirm whether the API is manufactured in-house or via contract API by checking:
- DMF-linked references in filings (when publicly disclosed)
- the API manufacturing site names appearing in regulatory submissions and listing records
This approach is faster and more reliable than generic “supplier lists” because opioid supply changes by batch, site qualification, and commercial contracts.
What data do suppliers usually need to provide for oxymorphone hydrochloride supply?
For controlled-opioid procurement, supplier qualification typically includes:
- DEA registration coverage for the specific opioid substance or intermediate
- GMP manufacturing compliance for the API and/or drug product
- Certificate of Analysis (CoA) per batch, including impurity profile and residual solvents where applicable
- Chain-of-custody documentation for controlled substances
- Quality agreements (QAA) and change control commitments
Supplier landscape by supply chain node
| Supply-chain node |
Typical supplier category |
What it means for sourcing oxymorphone hydrochloride |
| Finished-dose (tablet) |
Branded and generic finished-dose manufacturers |
The “supplier” most visible to buyers; changes by ANDA/NDA and site qualification |
| API |
DEA-registered opioid API manufacturers |
Determines API availability, impurity profile control, and batch release robustness |
| CMO/intermediate production |
Contract manufacturing and intermediate suppliers |
Impacts lead times and feasibility for new or relaunch programs |
How concentrated is oxymorphone hydrochloride supply?
Oxymorphone supply concentration is structurally high because:
- controlled-substance compliance requirements limit eligible producers
- opioid API manufacturing and intermediate synthesis require tight regulatory controls
- supplier networks for opioids shift toward fewer, highly qualified sites over time
Key Takeaways
- Oxymorphone hydrochloride supply is typically anchored in the branded and authorized generic supply chains plus DEA-registered API/CMO manufacturing networks.
- For business-critical procurement or diligence, supplier identification must be mapped at the SKU level using the ANDA/NDA holder and current manufacturing site listings, not broad market “supplier lists.”
- The most actionable supplier list is a node-specific map: finished-dose manufacturers for the commercial product and separate API/CMO qualification for production continuity.
FAQs
-
What is the fastest way to identify the real supplier for a specific oxymorphone hydrochloride product?
Map the product SKU (dose form and strength) to its ANDA/NDA holder and extract the current manufacturing sites from the most recent regulatory listing.
-
Are oxymorphone hydrochloride suppliers the same across different strengths?
Not necessarily. Manufacturing sites and API sources can vary by strength, batch allocation, and commercial agreements.
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Why does oxymorphone hydrochloride supply depend heavily on DEA-registered manufacturers?
The substance is controlled, so eligible API and often finished-dose production require DEA registration and controlled-substance compliance.
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Can API suppliers change without changing the finished-dose labeler?
Yes. Finished-dose labelers can switch API suppliers through change control while maintaining the same marketing authorization, subject to regulatory requirements.
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What documentation matters most when qualifying a supplier for oxymorphone hydrochloride?
DEA registration coverage, GMP compliance, batch-level CoAs, impurity and residuals reporting, chain-of-custody, and a quality agreement.
References
[1] FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (oxymorphone hydrochloride). https://www.accessdata.fda.gov/scripts/cder/daf/
[2] FDA. Drug Manufacturing Safety and Quality initiatives and current GMP expectations for drug substances and drug products. https://www.fda.gov/drugs/drug-manufacturing-safety-and-quality
[3] DEA. Controlled Substances Act and DEA registration requirements for controlled substances manufacturing and handling. https://www.dea.gov/controlled-substances-act
