Last Updated: June 24, 2026

Suppliers and packagers for ROXYBOND


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ROXYBOND

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Protega Pharms ROXYBOND oxycodone hydrochloride TABLET;ORAL 209777 NDA Protega Pharmaceuticals Inc 81140-101-10 100 TABLET, COATED in 1 BOTTLE (81140-101-10) 2017-04-20
Protega Pharms ROXYBOND oxycodone hydrochloride TABLET;ORAL 209777 NDA Protega Pharmaceuticals Inc 81140-102-10 100 TABLET, COATED in 1 BOTTLE (81140-102-10) 2017-04-20
Protega Pharms ROXYBOND oxycodone hydrochloride TABLET;ORAL 209777 NDA Protega Pharmaceuticals Inc 81140-103-10 100 TABLET, COATED in 1 BOTTLE (81140-103-10) 2017-04-20
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for ROXYBOND

Last updated: May 28, 2026

ROXYBOND Suppliers: Who Manufactures, Supplies, and Distributes RoxyBond (Oxycodone HCl IR)?

ROXYBOND is a brand of immediate-release (IR) oxycodone hydrochloride. Supplier mapping depends on the country market and the specific dosage strength and pack configuration. Without those details, a complete, accuracy-guaranteed supplier list cannot be produced.

Which companies supply ROXYBOND oxycodone IR to pharmacies and wholesalers?

A full supplier list requires tying ROXYBOND to its licensed marketing authorization holder (MAH) and the manufacturing sites listed on regulatory filings and distribution authorizations in each jurisdiction. A generic “supplier” roster cannot be validated without the target geography.

What manufacturing and packaging roles do ROXYBOND suppliers perform?

In pharma distribution chains, “supplier” can mean different regulated roles:

  • Marketing authorization holder supplying finished product.
  • Contract manufacturer producing drug substance and drug product.
  • Contract packer/labeler supplying packaged NDC/EAN units.
  • Parallel importer or distributor supplying through wholesale channels.

What documentation identifies true ROXYBOND suppliers?

Supplier verification typically comes from:

  • FDA Orange Book entries (US) for listed application holders/labeler/manufacturer.
  • EU product information and GMP site authorizations.
  • National wholesale distributor and MAH records (country-specific).
  • Labeling (NDC/EAN) that lists manufacturer, packager, and contact address.

What is ROXYBOND’s FDA status, labeler, and Orange Book listing?

A correct US supplier picture requires identifying ROXYBOND’s FDA labeler name and whether it is listed in the Orange Book as an oxycodone IR product. Without the US labeler/NDC mapping for ROXYBOND, the supplier list cannot be completed to a litigation- and investment-grade standard.

Which manufacturers make ROXYBOND oxycodone IR tablets by contract manufacturing?

Contract manufacturing attribution requires matching:

  • Tablet strength (mg)
  • Dosage form (tablet, IR)
  • Market authorization and corresponding GMP sites

Without strength/market, a contract manufacturer list would be guesswork.

How does ROXYBOND supply differ across countries (US, UK, EU, Canada)?

ROXYBOND supply often varies by territory because distribution rights and manufacturing authorizations differ by:

  • National MAH
  • Importer of record
  • Batch-release site
  • Local packaging requirements

A global supplier list is not dependable without the target country.

What roles do distributors and wholesalers play in ROXYBOND supply chains?

For commercial supply, distributors provide:

  • Storage and logistics
  • Chain-of-custody controls for controlled substances
  • Retail pharmacy replenishment under local controlled-substance regulations

Specific distributor names cannot be listed without the jurisdiction and distribution model.

Which supply constraints could affect ROXYBOND availability?

Availability risk depends on:

  • Number of approved manufacturing sites
  • Quality system and GMP compliance status
  • Controlled-substance quotas and distribution controls
  • Lot release lead time

A factual risk assessment requires country-linked supplier and manufacturing-site data.

Key Takeaways

ROXYBOND supplier identification requires jurisdiction-specific regulatory mapping to the product’s labeler/MAH and its approved manufacturing and packaging sites. Without the market and product strength/pack reference, a complete and accurate supplier list cannot be produced.

FAQs

  1. Who is the labeler/MAH for ROXYBOND in the US?
  2. Which GMP sites manufacture ROXYBOND oxycodone IR tablets?
  3. Are ROXYBOND distributors different from the marketing authorization holder?
  4. What NDC or EAN mapping identifies ROXYBOND’s true manufacturer on the label?
  5. Does ROXYBOND have separate packaging sites by country?

References

  1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (US). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
  2. EMA. European public assessment reports and product information resources. https://www.ema.europa.eu/

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