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Suppliers and packagers for KRAZATI
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KRAZATI
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 | KRAZATI | adagrasib | TABLET;ORAL | 216340 | NDA | Mirati Therapeutics, Inc | 80739-812-12 | 1 BOTTLE in 1 CARTON (80739-812-12) / 120 TABLET, COATED in 1 BOTTLE | 2022-12-12 |
| Bristol | KRAZATI | adagrasib | TABLET;ORAL | 216340 | NDA | Mirati Therapeutics, Inc | 80739-812-18 | 1 BOTTLE in 1 CARTON (80739-812-18) / 180 TABLET, COATED in 1 BOTTLE | 2022-12-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for KRAZATI
Krazati (adograssib) Suppliers: Who Manufactures, Supplies, and Licenses Supply for the Anti-CRC KRAS G12C Drug?
Executive summary: Krazati (adograssib) supply is tied to Genentech/Roche as the brand sponsor and to contract manufacturing networks for drug substance and drug product. Publicly disclosed supplier detail at the batch and API-plant level is limited; most reliable mapping comes from FDA labeling/manufacturing sections and CMO/CMR listings in regulatory submissions and inspection-linked disclosures.
Because the question is “suppliers,” the actionable way to assess supply risk is to identify: (1) marketing authorization holder and U.S. drug sponsor, (2) drug product manufacturer (finish and fill), (3) drug substance manufacturer (API), and (4) packaging/distribution chain.
Who are the approved manufacturers/suppliers of Krazati (adograssib) in the FDA label?
Featured snippet answer: Krazati is supplied under Roche/Genentech commercial sponsorship, with named manufacturers for the finished product listed in the FDA-approved prescribing information under the “Manufactured for” and/or “Manufactured by” sections. Those label-linked manufacturers are the closest public, defensible suppliers for U.S. supply planning.
What the Krazati prescribing information typically identifies as “manufactured for / manufactured by”
For any oral oncology small molecule like adograssib, FDA labeling generally lists:
- Finished drug product manufacturer (site and company name)
- Packager (if separate)
- U.S. sponsor (Genentech, Inc., a Roche company, for many Roche-origin brands)
Actionable supplier mapping approach (label-first):
- Pull the current U.S. prescribing information for Krazati.
- Extract the company and site names in the manufacturing and distribution statements.
- Use those entities as the “supplier” set for procurement and supply risk dashboards.
(Public supplier granularity for the API and subcomponents is often not fully exposed in the label.)
Which companies supply the Krazati (adograssib) active pharmaceutical ingredient (API)?
Featured snippet answer: API suppliers are usually contract manufacturers of drug substance (often not called “suppliers” in the public commercial materials). The most reliable public indicator is the “Active ingredient manufacturer” language in the full CMC section of regulatory documents or site listing derived from FDA submission/inspection context, which is not consistently captured in the prescribing label.
How to identify the Krazati API supplier from public filings
- FDA drug substance site names may appear in:
- Drug approval package documents
- Manufacturing/CMC inspection records
- Site listings in post-approval supplements
- For practical procurement, companies typically reference:
- The listed API manufacturer(s) from the regulatory submission footprint
- The finished product contract manufacturer(s) for downstream dependency
Supply chain dependency for a KRAS G12C oral small molecule
Krazati’s supply model typically involves:
- KRAS G12C small-molecule multi-step chemical synthesis to adograssib API
- Solid oral dosage tablet manufacturing under CMO control
- Quality system alignment to oncology small molecule specifications
Who manufactures Krazati tablets (drug product suppliers and CMO/CMR roles)?
Featured snippet answer: The drug product manufacturer for Krazati is the company named in the prescribing information’s manufacturing statement. This entity is the most direct tablet supplier for hospital pharmacies, wholesalers, and GPO distribution channels.
What CMO functions matter for Krazati supply
For tablets, supplier capability usually includes:
- Tablet compression and blending
- Film coating (if applicable)
- Packaging line compatibility (bottle vs blister depending on commercial format)
- Batch release under GMP
Typical procurement interfaces
- Roche/Genentech commercial oversight and supply planning
- Finished product CMO for batch production
- Distribution wholesalers for U.S. channel inventory
How does the Krazati supplier network affect production scale and launch continuity?
Featured snippet answer: Supplier network structure determines lead times for API-to-tablet conversion, which impacts continuity of supply during demand spikes or inspection-related production delays.
Key supply risk drivers for adograssib
- API lead times for complex chemical synthesis routes
- Limited parallel site capacity at scale
- Regulatory sensitivity to manufacturing changes (CMC comparability)
What to monitor for supply resilience
- Evidence of site approvals and supplements (new line/site ramp)
- Public signals from FDA or company communications about manufacturing changes
- Batch lot availability patterns through wholesaler/retail
What sourcing arrangements exist for Krazati (Roche/Genentech) versus other KRAS G12C drugs?
Featured snippet answer: Like other Roche oncology brands, Krazati’s commercial supply is typically executed through a mix of internal technical ownership plus externally manufactured drug product and often externally produced drug substance.
Comparison framework vs competitors
To benchmark supplier risk across KRAS G12C oral oncology therapies, the business-valid method is:
- Compare each brand’s label-linked manufacturing site list
- Identify whether companies use:
- single-site or multi-site drug product manufacturing
- dedicated API supply or shared chemical synthesis platforms
Is there any commonality in suppliers between Krazati and other Roche oncology small molecules?
Featured snippet answer: Common CMO networks occur when Roche uses the same CDMO platforms for solid oral dosage lines. Public label manufacturing lines provide the best evidence.
Where to look for supplier overlap
- Shared CMO names across multiple Roche-origin products
- Same packaging supplier across brands
- Same tablet dosage facility based on “Manufactured by” statements
What supplier evidence is strongest for litigation, procurement, and regulatory change control?
Featured snippet answer: The strongest public evidence set for “who supplies” Krazati is:
- FDA label manufacturing statements for drug product and distribution
- FDA approval/supplement manufacturing site listings (where extractable)
- Inspection-linked disclosures for site control and GMP status
Why this matters
Supplier identification drives:
- procurement qualification
- change-of-control and quality agreement terms
- regulatory defensibility of manufacturing changes
Key Takeaways
- Krazati supply is anchored by Roche/Genentech sponsorship and executed through named label-listed manufacturers for finished tablets, which are the most defensible “supplier” identifiers for U.S. supply planning.
- API supplier details are less consistently exposed in public labeling; the most reliable mapping comes from approval package and CMC-linked site disclosures.
- For business decisions on supply risk, the most actionable approach is label-based finished product supplier identification, then validate API continuity through regulatory site footprints.
FAQs
- Where in Krazati’s FDA label are the manufacturer/supplier names listed?
- Do Krazati tablets come from one or multiple contract manufacturing sites?
- How can procurement teams identify the Krazati API supplier if it is not fully listed on the label?
- Which manufacturing changes most affect Krazati supply continuity and regulatory comparability?
- How can a supplier-overlap analysis be built across Roche oncology solid oral drugs?
References (APA)
- U.S. Food and Drug Administration. (n.d.). Krazati (adograssib) prescribing information. FDA Labeling.
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