Share This Page
Suppliers and packagers for generic pharmaceutical drug: aspirin; oxycodone hydrochloride
✉ Email this page to a colleague
aspirin; 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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
Suppliers and packagers for generic pharmaceutical drug: aspirin; oxycodone hydrochloride
Aspirin and Oxycodone Hydrochloride Suppliers: Who Manufactures and Supplies Active Ingredients (API) and Finished Dosage Forms?
Supplier lists for both aspirin and oxycodone hydrochloride depend on the exact market context (API vs finished dosage forms, US vs EU vs global, branded vs generic, and whether the buyer needs DMFs, CEPs, or GMP audit readiness). The only way to provide a complete, decision-grade answer with named suppliers and verifiable sourcing status is to anchor to specific regulatory listings (FDA Orange Book for finished products, FDA Drug Registration and Listing for manufacturers, and FDA DMF/CEF status for APIs).
No source package, jurisdiction scope, dosage forms, or regulatory listing targets were provided. Without those anchors, any named “supplier” roster would be incomplete and not litigation or procurement usable.
What are the common supply chains for aspirin and oxycodone hydrochloride (API vs finished dosage forms)?
Aspirin
- Typical supply split:
- API manufacturers supply acetylsalicylic acid (ASA) under GMP.
- Finished dosage form manufacturers produce tablets/capsules under their own GMP, using sourced API.
- Buyer-facing documentation often centers on:
- GMP certificates and batch traceability
- CoA release specs
- Regulatory dossiers (DMF/CEP depending on region)
Oxycodone hydrochloride
- Typical supply split is more constrained due to:
- Controlled-substance handling requirements
- Higher compliance burden (DEA licensing in the US, security and recordkeeping)
- More intensive customer qualification
- Buyer-facing documentation often centers on:
- DEA registration for manufacturing and distribution where required
- GMP, controlled-substance security plans
- Batch traceability and diversion-control systems
Which suppliers make aspirin API (acetylsalicylic acid) and sell to finished-dose manufacturers?
No complete, verifiable supplier list can be produced from the prompt alone. A decision-grade roster requires tying named firms to:
- API dossier status (eg, DMF in the US)
- US drug establishment registrations (FDA)
- GMP inspection history and approval/licensing state
- Whether the supplier sells API, intermediates, or only finished product
Which companies supply oxycodone hydrochloride API and controlled-substance finished dosage forms?
A reliable named supplier list for oxycodone hydrochloride requires regulatory and licensing linkage (controlled-substance authorization and establishment listings). Without:
- the targeted region(s),
- whether the buyer needs API vs finished goods,
- the specific strengths and dosage forms (immediate-release vs extended-release),
- and the intended market entry route (US branded/generic, EU national, etc.), any supplier names would risk factual mismatch with current licensing and the specific dosage product form required.
How do supplier qualification and documentation differ for aspirin vs oxycodone hydrochloride?
Aspirin supplier qualification
- Standard pharmaceutical vendor qualification:
- GMP compliance at API and/or finished-dose site(s)
- analytical method validation and CoA consistency
- impurity profile control (ASA-related impurities)
- Lower regulatory friction relative to controlled substances, so the qualification process is typically more streamlined.
Oxycodone hydrochloride supplier qualification
- Expanded qualification scope due to diversion risk controls:
- controlled-substance registrations and secure warehousing
- inventory controls and reconciliation procedures
- audit trails and chain-of-custody
- Tight operational constraints can reduce the number of eligible vendors for buyers.
What are the regulatory listing sources that identify real suppliers?
To generate an accurate supplier list, suppliers must be mapped to public regulator datasets:
- US finished products
- FDA Orange Book identifies NDA/ANDA products and listed patents; it also points to drug applicants/manufacturing info in the related label and application records.
- US establishment and product listing
- FDA Drug Registration and Listing identifies registered manufacturing sites by product and role.
- US API dossiers
- DMF references (and sometimes RLD/Reference Listed Drug linking) identify API filing sites.
- EU
- National competent authority registers and CEP holders (where used) identify API sourcing for regional dossiers.
- Controlled substance
- For oxycodone, supplier eligibility must align with controlled-substance handling authorizations in the relevant jurisdiction.
Key Takeaways
- A procurement-grade supplier list for aspirin and oxycodone hydrochloride cannot be produced from the current prompt because it lacks the required regulatory anchors (region, API vs finished-dose, dosage form/strength, and listing targets).
- Aspirin supply sourcing is typically easier to validate through standard GMP and dossier records.
- Oxycodone hydrochloride sourcing is constrained by controlled-substance regulatory authorization and secure manufacturing/distribution requirements.
- Decision-grade supplier identification requires mapping firms to regulator-linked listings (US Orange Book for product applicants, FDA establishment listings for sites, and DMF/CEP-style dossier records for APIs) and aligning with controlled-substance authorization where applicable.
FAQs
- What is the difference between aspirin API suppliers and finished dosage manufacturers in procurement?
- Which documentation matters most when qualifying oxycodone hydrochloride suppliers?
- How do you validate whether a supplier can provide controlled-substance oxycodone hydrochloride for commercial supply?
- What regulatory data sources identify legitimate aspirin and oxycodone hydrochloride manufacturing sites?
- How do API impurity specs and CoA release criteria typically differ between aspirin and oxycodone hydrochloride?
References
No sources were provided in the prompt, and no regulator listing or product dossier identifiers were given to support citation-grade supplier identification.
More… ↓
