OXYCODONE AND ASPIRIN: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Epic Pharma Llc	OXYCODONE AND ASPIRIN	aspirin; oxycodone hydrochloride	TABLET;ORAL	040910	ANDA	Epic Pharma, LLC	42806-061-01	100 TABLET in 1 BOTTLE (42806-061-01)	2020-06-30
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 14, 2026

Suppliers for Oxycodone and Aspirin APIs, Finished Dosage Forms, and Excipients: Who Provides What for Manufacturing and Distribution

Suppliers for oxycodone plus aspirin products break into three procurement lanes: (1) controlled-substance supply for oxycodone (API and/or intermediates), (2) aspirin (API and compression-coating-grade excipient inputs), and (3) finished-dose manufacturing and packaging. In practice, upstream oxycodone supply is dominated by licensed opioid API manufacturers and intermediate producers with DEA registration and state controlled-substance credentials, while aspirin supply is broader and more commoditized across chemical and tableting supply chains.

Which companies supply oxycodone API and intermediates for combination analgesics?

What supplier categories exist for oxycodone

Oxycodone supply is typically sourced through one or more of the following channels:

API manufacturers producing oxycodone (or oxycodone hydrochloride) under GMP for pharmaceutical use.
Intermediate producers supplying regulated precursors and intermediates that are then converted to oxycodone API by downstream API houses.
Licensed contract manufacturers that formulate and table/encapsulate oxycodone products using a purchased API.
Distributor and broker networks for regulated substances that consolidate cold-chain and controlled-substance logistics under compliant DEA/state pathways.

For combination products containing oxycodone and aspirin, the key procurement point is whether the supplier delivers:

API oxycodone plus a separate API aspirin, or
a co-formulated intermediate blend (less common), or
finished dose ready for packaging.

High-risk supply constraints

Oxycodone procurement is constrained by:

DEA registration at manufacturing and distribution nodes,
state controlled-substance registrations where warehousing and distribution occur,
quota-like or licensing friction tied to procurement controls,
auditability of chain-of-custody and GMP documentation.

Common sourcing patterns

Most sponsors and CDMOs do one of two approaches:

Dual sourcing: oxycodone API from one or two DEA-licensed API manufacturers, aspirin API from multiple competitive sources, then formulation by a contract manufacturer.
Single-source API strategy with CDMO: oxycodone API procured from a validated supplier, aspirin sourced more flexibly, formulation and packaging outsourced.

Which suppliers provide aspirin API for oxycodone/aspirin tablets or capsules?

Aspirin supply is broader than oxycodone

Aspirin API sourcing is typically less constrained than oxycodone due to:

fewer regulatory hurdles at the manufacturing node,
larger numbers of GMP aspirin manufacturers,
multiple salt/grade equivalents depending on product specification.

Aspirin inputs for solid oral dosage manufacture can include:

aspirin API (acetylsalicylic acid),
compliant grades aligned to particle size targets for content uniformity,
excipient-related raw materials used to manage tablet hardness and dissolution.

Procurement focus for aspirin

Purchasing teams usually qualify suppliers on:

assay and impurity profile (including related substances),
particle size distribution affecting blend uniformity,
moisture content for stability in the final tablet blend.

Which excipient and packaging suppliers support oxycodone/aspirin solid dose manufacture?

Excipient suppliers: typical bill-of-material inputs

Oxycodone/aspirin tablets require standard solid oral excipients. Common categories include:

binders (granulation or direct compression),
disintegrants (tablet breakup and dissolution),
lubricants (flow and compression),
glidants (powder flow),
coating systems (if the dosage is film-coated),
packaging components (bottles, caps, blister materials, desiccants).

Packaging requirements

Where the product is distributed as regulated opioid medication, packaging procurement must align with:

tamper-evident bottle cap and/or blister sealing specs,
labeling and serialization requirements where applicable,
moisture control and child-resistant packaging where mandated.

What contract manufacturers make oxycodone/aspirin finished dosage forms (tablets, capsules)?

Finished-dose manufacturing pathways

Combination products are usually produced by:

CDMOs with controlled-substance handling capability, which use GMP facilities with validated security and chain-of-custody procedures; and/or
vertically integrated producers that manage API receipt, blending, compression, coating, and packaging under one compliance system.

What to qualify in a CDMO

Procurement and tech transfer teams typically qualify CDMOs based on:

DEA and state controlled-substance license coverage for the site,
validated cleaning and segregation controls,
ability to handle both controlled and non-controlled actives in the same facility,
demonstrated yield and dissolution performance consistent with reference product specs.

Which FDA regulatory filings show supplier relationships for oxycodone/aspirin?

Orange Book listings and DMF linking

For U.S. products, supplier qualification commonly traces through:

FDA Orange Book entries tied to approved NDA/ANDA products,
DMFs (Drug Master Files) for intermediates or excipients,
labeling and manufacturing information in approval packages.

Practical procurement use

Business teams use Orange Book and DMF linkages to:

identify which manufacturing sites are tied to the approved product,
determine whether upstream API is sourced through DMFs or by direct NDA references,
assess whether an alternative supplier would require separate regulatory bridging.

How do DEA and state licensing affect who can supply oxycodone for combination products?

Supplier eligibility

Oxycodone supply is limited to entities with:

DEA registration for the specific activity (manufacture, distribution, import/export),
controlled substance handling security controls,
state registrations for warehousing/distribution activities.

What happens at distribution

If a supplier is a distributor rather than a manufacturer, chain-of-custody compliance becomes the procurement bottleneck:

documentation completeness,
verified custody logs,
audit trail availability.

What generic entry risks exist for oxycodone/aspirin if suppliers change?

Regulatory and formulation transfer risks

Changing oxycodone or aspirin supplier can trigger:

additional analytical characterization,
re-validation of blend uniformity, dissolution, and stability,
potential reformulation work if particle size or excipient compatibility shifts.

Commercial impact

Supplier substitution can increase:

tech transfer timelines,
batch failures risk,
costs tied to stability studies and regulatory reporting.

Supplier landscape: how oxycodone/aspirin supply chains typically compare to other opioid combos

Why oxycodone supplier count is narrower

Compared with non-controlled analgesic combinations, oxycodone’s supplier pool is narrower because controlled-substance manufacturing and handling requires:

DEA site registration,
quota-like internal procurement controls,
compliance-heavy audits and documentation.

Aspirin offsets some leverage

Aspirin’s more commoditized status gives buyers:

leverage on price,
optionality on manufacturing sites,
easier second-source qualification.

Key Takeaways

Oxycodone supply is the gating item: only DEA and state-licensed manufacturers and compliant controlled-substance distributors can reliably support commercial-scale production of oxycodone/aspirin products.
Aspirin supply is broader and more competitive, but buyers still must qualify impurity and particle-size specs for tablet performance.
The procurement model is usually “regulated active plus commodity active,” followed by formulation and packaging through a CDMO capable of controlled-substance handling.
Supplier switching can create regulatory and product-performance risk through blend uniformity, dissolution, and stability impacts.

FAQs

1) How do manufacturers source oxycodone for commercial tablets when multiple DEA-licensed sites exist?
They typically dual-source oxycodone API and use validated receiving and chain-of-custody controls, then lock final blend and dissolution specs during tech transfer.

2) Do aspirin suppliers need DEA registration to sell acetylsalicylic acid for combination products?
No, aspirin API is not a controlled substance in the same way oxycodone is; eligibility is primarily GMP and quality compliance rather than DEA.

3) What documentation is typically required when qualifying a new oxycodone API supplier?
GMP certificates, CoA with impurity profiles, validation batch data, and controlled-substance chain-of-custody documentation.

4) Can a CDMO buy oxycodone API and aspirin API and produce oxycodone/aspirin tablets under one master supply chain?
Yes, but only if the CDMO site holds the necessary controlled-substance licensing and has validated segregation, security, and cleaning controls.

5) How does supplier change affect dissolution and stability for oxycodone/aspirin tablets?
Changes in particle size, impurities, or excipient compatibility can shift granulation behavior and dissolution, requiring revalidation and stability updates.

References

No sources were provided in the request, and no specific manufacturer or FDA product identifiers were supplied; therefore no citations can be generated.

Suppliers and packagers for OXYCODONE AND ASPIRIN