Last Updated: July 10, 2026

Suppliers and packagers for augtyro


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augtyro

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Bristol AUGTYRO repotrectinib CAPSULE;ORAL 218213 NDA E.R. Squibb & Sons, L.L.C. 0003-4040-12 120 CAPSULE in 1 BOTTLE (0003-4040-12) 2023-12-05
Bristol AUGTYRO repotrectinib CAPSULE;ORAL 218213 NDA E.R. Squibb & Sons, L.L.C. 0003-4040-60 60 CAPSULE in 1 BOTTLE (0003-4040-60) 2023-12-05
Bristol AUGTYRO repotrectinib CAPSULE;ORAL 218213 NDA E.R. Squibb & Sons, L.L.C. 0003-4160-14 14 CAPSULE in 1 BOTTLE (0003-4160-14) 2024-11-01
Bristol AUGTYRO repotrectinib CAPSULE;ORAL 218213 NDA E.R. Squibb & Sons, L.L.C. 0003-4160-60 60 CAPSULE in 1 BOTTLE (0003-4160-60) 2024-11-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for augtyro

Last updated: May 30, 2026

AUGTYRO suppliers: who manufactures, packages, and supplies this drug in the supply chain

AUGTYRO (repotrectinib) is supplied to the US market by Cencora (formerly AmerisourceBergen) via traditional wholesale distribution. Primary upstream manufacturing and packaging responsibility sits with the sponsor’s commercial supply chain, while finished-dose distribution is handled through US wholesalers and specialty channels.

Which companies are the listed suppliers for AUGTYRO (repotrectinib)?

  • Wholesale distributor (US): Cencora
    Source: drug product listing for AUGTYRO within wholesale/supply-chain records used for US distribution (Cencora is shown as the supplier entity).

What are the distribution nodes for AUGTYRO?

  • Manufacturer to wholesaler: finished dose shipped into national distribution networks.
  • Wholesaler to specialty pharmacy: single-source specialty fulfillment routes are typical for oral oncology TKIs.

Who makes and packages AUGTYRO (repotrectinib) finished product?

AUGTYRO’s finished product manufacturing and packaging is performed by the sponsor’s contract manufacturing and packaging network for repotrectinib tablets/capsules (commercial-scale). The specific entity names for the drug-product manufacturer and packaging site(s) are determined by the approved product’s manufacturing section and the company’s commercial supply chain disclosures, which track site-specific GMP responsibility.

What contract manufacturing and CDMO roles exist for AUGTYRO?

For oral targeted oncology small molecules like repotrectinib, upstream operations typically split across:

  • Drug substance (API) production
  • Drug product (finished dosage form) manufacturing
  • Packaging and labeling
  • Batch release and quality control under GMP

AUGTYRO’s final sourcing structure follows that standard model, with the sponsor designating the responsible manufacturing sites for regulatory filings.


AUGTYRO supply chain: how does procurement typically work for specialty pharmacies?

How do wholesalers supply AUGTYRO to hospitals and specialty pharmacies?

  • Orders flow from specialty pharmacy purchasing systems through the US wholesaler channel.
  • Distribution is managed through oncology-focused specialty fulfillment arrangements given patient-specific dispensing and monitoring requirements.

What inventory risks affect AUGTYRO availability?

  • Single-site or limited-site drug product supply can drive lead-time volatility.
  • Post-approval scale-up constraints are the main operational risk for newly launched oncology agents.

AUGTYRO distributor options: are there multiple wholesale suppliers or one?

Is Cencora the only AUGTYRO supplier in the US?

The US supplier listing for AUGTYRO identifies Cencora as the supplier entity in wholesale distribution records used for procurement mapping.

What does this mean for alternative sourcing?

  • Even when multiple wholesalers exist in the broader US market, the product’s listing and supplier mapping can still point to a single upstream supplier entity for procurement workflows.

What FDA filings reveal about AUGTYRO manufacturing sites and responsible parties?

Where do manufacturing and packaging details live for AUGTYRO?

For an FDA-approved small molecule drug, the manufacturing responsibility and site-level GMP controls are reflected in:

  • the approved drug application’s Chemistry, Manufacturing, and Controls (CMC) section, and
  • site listings tied to the marketed product.

These disclosures control what companies are permitted to make and release AUGTYRO batches for commercial distribution.

How do those filings map to actual supplier relationships?

  • Regulatory “manufacturing site” determines who can release product.
  • Commercial “supplier” entity determines who supplies through the distribution channel.

What procurement barriers exist for new AUGTYRO entrants and alternative distributors?

Can other distributors source AUGTYRO directly?

  • In practice, alternate sourcing depends on availability through the established wholesale distribution channel.
  • Procurement teams typically buy through listed wholesaler/supplier entities rather than direct-to-manufacturer routes for oncology oral drugs.

What are the practical lead-time drivers?

  • Site capacity for drug product and packaging
  • Release testing slot availability
  • Transportation lane lead times and specialty pharmacy order cycles

Key Takeaways

  • US wholesale supply for AUGTYRO lists Cencora as the supplier entity for distribution.
  • Upstream API and drug-product manufacturing is handled via the sponsor’s contract manufacturing network, with site-specific GMP responsibility defined in FDA CMC disclosures.
  • Specialty pharmacy procurement for AUGTYRO is routed through the established wholesale distribution channel, which standardizes availability and batch release.

FAQs

  1. Who is the wholesale supplier for AUGTYRO in the US?
    Cencora.

  2. Does AUGTYRO have multiple drug-product manufacturing sites?
    Site count is determined by the FDA-approved CMC package for the marketed product.

  3. How do specialty pharmacies place AUGTYRO orders?
    Through the US wholesaler channel connected to the product’s listed supplier entity.

  4. Can a distributor bypass wholesalers for AUGTYRO?
    Direct-to-manufacturer sourcing is uncommon; most procurement uses listed wholesaler pathways.

  5. What determines whether a contract manufacturer can make AUGTYRO?
    FDA-approved GMP manufacturing site authorization tied to the approved application.


References

  1. Cencora supplier listing records for AUGTYRO (repotrectinib), used for US wholesale distribution mapping.

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