Suppliers and packagers for OXYCODONE HYDROCHLORIDE

OXYCODONE 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
Ani Pharms	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	CAPSULE;ORAL	205177	ANDA	ANI Pharmaceuticals, Inc.	62559-167-01	100 CAPSULE in 1 BOTTLE (62559-167-01)	2016-06-10
Avanthi Inc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	CAPSULE;ORAL	202773	ANDA	KVK-TECH, INC.	10702-023-01	100 CAPSULE in 1 BOTTLE (10702-023-01)	2015-08-20
Avanthi Inc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	CAPSULE;ORAL	202773	ANDA	KVK-TECH, INC.	10702-023-06	60 CAPSULE in 1 BOTTLE (10702-023-06)	2015-08-20
Novel Labs Inc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	CAPSULE;ORAL	204752	ANDA	Novel Laboratories, Inc.	40032-950-01	100 CAPSULE in 1 BOTTLE (40032-950-01)	2015-08-24
Novel Labs Inc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	CAPSULE;ORAL	204752	ANDA	Novel Laboratories, Inc.	40032-950-03	30 CAPSULE in 1 BOTTLE (40032-950-03)	2015-08-24
Novel Labs Inc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	CAPSULE;ORAL	204752	ANDA	Novel Laboratories, Inc.	40032-950-50	500 CAPSULE in 1 BOTTLE (40032-950-50)	2015-08-24

OXYCODONE HYDROCHLORIDE: Key Suppliers and Supply-Chain Proof Points

Last updated: April 24, 2026

Who supplies oxycodone hydrochloride API for pharmaceutical manufacturers?

Multiple global suppliers produce oxycodone hydrochloride (API) and related intermediates under cGMP and controlled-substance supply controls. The most business-relevant supplier set depends on whether you need API or finished dosage and whether you buy direct from an API manufacturer or via a distributor with DEA licensing and controlled-substance handling.

Below are supplier names used in pharmaceutical procurement and regulatory supply-chain contexts for oxycodone HCl (API and/or controlled-substance drug product supply).

API and controlled-substance supply sources (commercially active)

Supplier	Supply role	What they supply for oxycodone hydrochloride markets	Evidence pointer
Mallinckrodt (US)	API and/or drug product supply	Oxycodone hydrochloride products and related controlled-substance supply	Federal drug labeling and controlled-substance market presence for oxycodone formulations under Mallinckrodt branding (see FDA label system) [1]
Teva Pharmaceuticals (Israel/Global)	Drug product supply; controlled-substance distribution	Oxycodone hydrochloride immediate-release and extended-release products across US market	FDA label system for oxycodone hydrochloride formulations under Teva [1]
Purdue Pharma (US)	Drug product supply	Oxycodone hydrochloride formulations historically used in US controlled-substance market	FDA label system for branded oxycodone hydrochloride products under Purdue entities [1]
Endo Pharmaceuticals / Clarion Brands (US)	Drug product supply	Oxycodone hydrochloride formulations in the US market	FDA label system shows controlled-substance oxycodone HCl drug products attributed to Endo and related label holders [1]
AmerisourceBergen (US)	Distributor	Controlled-substance distribution for branded and generic oxycodone hydrochloride products	Controlled-substance distribution model for large wholesalers with DEA licensing (US controlled substance distribution infrastructure) [2]
McKesson (US)	Distributor	Controlled-substance distribution for oxycodone hydrochloride drug products	US wholesaler controlled-substance distribution channel (DEA-licensed distribution ecosystem) [2]
Cardinal Health (US)	Distributor	Controlled-substance distribution for oxycodone hydrochloride drug products	US wholesaler controlled-substance distribution channel (DEA-licensed distribution ecosystem) [2]

Key point for procurement: API supply for oxycodone HCl is tightly controlled and typically sold through DEA and import/export compliance plus cGMP documentation. Many manufacturers source finished dose through DEA-licensed wholesale distributors rather than importing API directly.

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Do DEA and importer controls narrow the set of “real” oxycodone hydrochloride suppliers?

Yes. Oxycodone hydrochloride is a Schedule II controlled substance, and supply is constrained by:

• DEA registration requirements for manufacturing, distribution, and import/export of Schedule II substances
• security, recordkeeping, and inventory controls
• licensed channeling through registered entities

This regulatory structure shapes which vendors can legally supply into a national market. The controlled-substance distribution model in the US is built around DEA-registered manufacturers and DEA-licensed distributors/wholesalers [2].

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What supplier categories matter most in real procurement?

Procurement teams typically face two workable routes:

Route A: Buy through DEA-licensed distributors (fastest route to product availability)

Common buyer outcomes:

• You purchase finished dose (tablet/capsule) rather than API
• You avoid API import and Schedule II handling complexity
• You rely on established wholesaler compliance and logistics

The main distributor category in US oxycodone hydrochloride supply is the large DEA-licensed wholesaler ecosystem (examples include AmerisourceBergen, McKesson, and Cardinal Health) [2].

Route B: Buy API from DEA-registered API manufacturers or API traders (highest compliance lift)

Common buyer outcomes:

• You obtain API under cGMP and compliance documentation
• You run DEA import/manufacturing compliance on your side (or via a registered partner)
• You perform tight qualification of supplier facilities, testing, and change control

The API set is smaller and more opaque than the drug product set, because you must also verify manufacturing controls and schedule compliance through regulatory documentation and supplier disclosures.

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Where is the supplier evidence located for oxycodone hydrochloride drug products?

The cleanest audit trail for “who supplies what into the market” is the FDA label database, which ties oxycodone hydrochloride formulations to label holders/marketing authorization entities. FDA labeling for oxycodone HCl products provides the firm identity for the marketed drug product, which in turn maps to actual supply responsibility in the US channel [1].

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How to map “supplier” to actual contract scope

When procurement says “supplier,” it often means one of these contract scopes:

1. Drug product supplier (finished dose)

   • Contracting with label holders or distributors with DEA logistics
   • For commercial operations, this is typically the most immediate option

2. API supplier

   • Direct qualification of API manufacturer
   • Requires cGMP dossier, impurity profile, stability data, and controlled-substance compliance documentation

3. Intermediates and manufacturing services

   • Some vendors provide oxycodone-related intermediates or contract manufacturing capability
   • These do not always equal final oxycodone hydrochloride API supply

For oxycodone hydrochloride, Route A typically dominates supplier lists available to business buyers because the market is visible via FDA-labeled products and wholesale distribution channels [1][2].

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What does the oxycodone hydrochloride “supplier landscape” look like in practice?

Based on the publicly visible US market structure:

Visible drug-product supplier set (label holders)

The following label-holding entities appear in FDA label records for oxycodone hydrochloride formulations:

• Mallinckrodt [1]
• Teva [1]
• Purdue (brand/private label entities) [1]
• Endo (and successor entities where labels are held) [1]

Distribution channel suppliers (wholesalers)

In the US controlled-substance distribution model, large wholesalers handle inventory movement under DEA controls:

• AmerisourceBergen [2]
• McKesson [2]
• Cardinal Health [2]

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Key operational constraints when selecting an oxycodone hydrochloride supplier

For Schedule II procurement, suppliers must satisfy buyer-facing controls that usually go beyond standard pharma qualification.

Compliance and documentation

• DEA registration fit for your role (importer/manufacturer/distributor)
• cGMP manufacturing controls and batch traceability
• Controlled-substance storage, security, and inventory reconciliation

US controlled-substance distribution is governed by DEA-licensed infrastructure and compliance programs [2].

Product and quality fit

• Impurity profile and test methods
• Stability and shelf-life agreement
• Change notification and deviation handling

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Practical shortlist (actionable, contract-ready)

If the goal is to secure supply in the US channel for oxycodone hydrochloride formulations, the most contract-ready shortlist typically includes:

Route A: Distribution or finished dose

• AmerisourceBergen (wholesale distribution) [2]
• McKesson (wholesale distribution) [2]
• Cardinal Health (wholesale distribution) [2]

Finished dose label holders that appear in FDA oxycodone hydrochloride labeling include:

• Mallinckrodt [1]
• Teva [1]
• Purdue entities [1]
• Endo entities [1]

Route B: API (direct)

API supplier names are not consistently visible at the same level as finished-dose label holders in the public labeling record; the procurement workflow usually targets:

• DEA-registered API manufacturers
• qualified suppliers with verified cGMP documentation
• contract manufacturing or trading partners with controlled-substance logistics

In practice, buyers often start with Route A unless they have an existing API qualification program and DEA operational capability [2].

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Key Takeaways

• Oxycodone hydrochloride supply in major markets is constrained by Schedule II DEA controls, which shape who can legally manufacture, distribute, or import.
• The most visible supplier set comes from FDA oxycodone hydrochloride labels (label holders) and DEA-licensed wholesaler distribution (AmerisourceBergen, McKesson, Cardinal Health) [1][2].
• If you need finished dosage, Route A gives the most contract-ready access. If you need API, expect tighter vendor qualification and controlled-substance compliance requirements.

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FAQs

1) What is the fastest way to source oxycodone hydrochloride supply commercially?

Buy finished-dose products through DEA-licensed distributors. This aligns with the US controlled-substance distribution channel dominated by major wholesalers [2].

2) Who are the common US distributors for oxycodone hydrochloride products?

Large DEA-licensed wholesalers used in controlled-substance distribution include AmerisourceBergen, McKesson, and Cardinal Health [2].

3) How can I verify who markets oxycodone hydrochloride products in the US?

Use FDA label records for oxycodone hydrochloride formulations to identify the label holder responsible for marketed products. Examples of label holders include Mallinckrodt, Teva, Purdue, and Endo [1].

4) Is oxycodone hydrochloride supply easier if I buy API instead of finished dose?

API sourcing is usually harder operationally because Schedule II procurement requires cGMP and DEA compliance for manufacturing/import and controlled-substance handling. Finished-dose sourcing through distributors avoids much of that workflow [2].

5) Does DEA licensing affect which “suppliers” can sell to my entity?

Yes. Controlled-substance supply for Schedule II substances depends on DEA registration and controlled-substance compliance, limiting the legal supplier set to registered entities and permitted channels [2].

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References

[1] U.S. Food and Drug Administration (FDA). Drug Labels (Oxycodone hydrochloride product labels). https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-04-24).
[2] U.S. Drug Enforcement Administration (DEA). Controlled Substances laws and registration requirements (Schedule II distribution and handling framework). https://www.deadiversion.usdoj.gov/ (accessed 2026-04-24).