Suppliers and packagers for AVEED

AVEED

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Endo Operations	AVEED	testosterone undecanoate	INJECTABLE;INTRAMUSCULAR	022219	NDA	Endo USA, Inc.	67979-511-43	1 VIAL, SINGLE-USE in 1 CARTON (67979-511-43) / 3 mL in 1 VIAL, SINGLE-USE	2014-03-05

Suppliers and packagers for AVEED

Last updated: May 24, 2026

Aveed (testosterone undecanoate) suppliers: who manufactures, supplies, and sources the drug product and key components?

Executive summary: Aveed is supplied in the U.S. by Endo Pharmaceuticals Inc. (brand owner/distributor). The drug product (Aveed injection, testosterone undecanoate) is manufactured under Endo’s commercialization structure, with formulation/aseptic fill-finish performed by contract manufacturing organizations aligned to Endo’s supply chain. No complete, citable supplier roster (manufacturer-by-manufacturer, site-by-site) is available in the materials provided here, so a definitive supplier list cannot be produced.

What companies supply Aveed testosterone undecanoate in the US?

Answer (direct): Endo Pharmaceuticals Inc. is the U.S. supplier/distributor of Aveed. A full supplier roster that identifies specific manufacturing sites and upstream component suppliers is not available in the provided information.

Who is the marketing authorization holder or brand distributor?

• Endo Pharmaceuticals Inc. (Aveed commercialization/supply in the U.S.)

Are there contract manufacturers for the Aveed injection?

• Aveed injection requires sterile aseptic manufacturing and fill-finish (typical for injectable depot formulations).
• The specific CDMO names and sites are not provided in the available dataset.

How does Aveed’s supply chain work for sterile depot injections?

Answer (direct): Aveed is a sterile injectable depot product, which typically requires:

• aseptic drug substance handling and conversion to injection-ready bulk
• sterile fill-finish
• cold-chain or controlled room temperature logistics depending on packaging and stability specs

What are the manufacturing steps that drive supplier selection?

• drug substance sourcing and conversion to bulk
• aseptic sterile filling
• secondary packaging (carton/labeling)
• release testing and distribution logistics

What raw-material and equipment suppliers support testosterone undecanoate injectables?

Answer (direct): Raw-material and equipment suppliers are not enumerated in the information provided here, so a supplier-by-supplier list cannot be published.

Which input categories matter for depot testosterone undecanoate?

• testosterone undecanoate drug substance or key intermediates
• sterile injectable excipients and solvents
• containment and delivery components (vial, rubber closures, syringe systems if applicable)
• aseptic processing systems and QC/sterility assurance tooling

Which contract manufacturing organizations (CMOs) make Aveed injection?

Answer (direct): The CMO or fill-finish site identities are not supplied in the available information, so they cannot be listed.

How to interpret “supplier” when users ask for manufacturing sources

• For investor and litigation-grade diligence, “supplier” typically means:
  • drug product manufacturer of record (DP-MFR)
  • drug substance manufacturer of record (DS-MFR)
  • sterile fill-finish site
• Those records are not included in the material provided.

What does Aveed’s FDA regulatory status imply about manufacturing responsibility?

Answer (direct): FDA approval ties regulatory responsibility to the application holder and listed manufacturing sites. Without the cited Orange Book/label/manufacturing section content here, manufacturing sites cannot be named.

Where manufacturing details usually appear

• prescribing information “Manufactured for/Distributed by”
• FDA label sections listing “manufactured by” and site addresses
• regulatory submissions that list DS/DP manufacturers

Which biosimilar or generic challenges affect Aveed supply risk?

Answer (direct): Aveed is a brand product; competitive entry risk exists through potential generics/alternatives. However, supplier risk depends on whether alternative products qualify for scale-up and sterile depot capacity. The required filings and litigation data are not included in the provided information, so no challenge-specific risk map can be produced.

When do supply constraints emerge for testosterone undecanoate injections?

Answer (direct): Supply constraints commonly emerge from:

• sterile fill-finish capacity limits
• drug substance availability
• regulatory site changes and batch release bottlenecks No Aveed-specific constraint timeline is present in the available information.

Key Takeaways

• Endo Pharmaceuticals Inc. is the U.S. supplier/distributor of Aveed (testosterone undecanoate injection).
• A complete, citable list of drug product manufacturing sites and upstream raw-material suppliers is not available in the provided information, so it cannot be stated as fact.

FAQs

1. Who distributes Aveed in the United States?
   Endo Pharmaceuticals Inc.
2. What type of manufacturing does Aveed require?
   Sterile injectable depot manufacturing with aseptic fill-finish.
3. Are there multiple suppliers for Aveed drug substance or raw materials?
   Not determinable from the provided information.
4. Do generic or alternative testosterone undecanoate products affect Aveed supply?
   They can affect market allocation, but product-specific challenge data is not provided here.
5. Where can Aveed manufacturing site information be found?
   In prescribing information “manufactured/distributed” sections and regulatory listings, which are not included in the provided dataset.

References

1. (No citable sources were provided in the input.)