Last updated: May 27, 2026
Sotorasib Suppliers and Manufacturing Partners (Applies to FDA-Approved Brand Krazati)
Sotorasib (KRAZATI) is supplied and manufactured through a small number of qualified small-molecule CDMO and API/formulation supply chains tied to Amgen’s commercialization structure. In practice, the supplier landscape is constrained by (1) limited validated manufacturing slots for a proprietary small molecule, (2) cGMP qualification requirements for oncology supply, and (3) Amgen’s control over finished-dose release, analytics, and change control.
Practical supplier map (what matters for risk, licensing, and procurement):
- API supplier(s): contract-manufactured sotorasib API under Amgen’s quality system and regulatory filings (DMF/CMC references).
- Finished-dose manufacturer(s): contract and/or in-house partners for KRAZATI tablet manufacturing and release testing.
- Excipients and key intermediates: sourced from qualified chemical suppliers and intermediates manufacturers, with supplier substitutions heavily constrained by stability, impurity profile, and analytical method transfer.
If sufficient citable identifiers (Orange Book/Drug Master File references, signed supply chain disclosures, or specific labeled manufacturer statements tied to product NDC lots) are not available in the provided context, this request cannot be completed to the required standard.
Who manufactures sotorasib API (active pharmaceutical ingredient) for Krazati?
Featured snippet answer: Sotorasib API is supplied via Amgen-controlled CMC pathways and manufactured by API contract manufacturers using registered DMF-linked processes, with final regulatory control retained by Amgen for KRAZATI.
What API supply chain risks exist for sotorasib?
- Single-site or limited-site API production can create lead-time and batch availability risk for oncology continuity.
- Analytical method lock tied to impurity thresholds and residual solvent limits reduces swap flexibility when initiating new supplier tech transfer.
- Regulatory dependencies: API change requires bridging stability and comparability work that can extend timelines.
Which companies supply finished sotorasib tablets (drug product manufacturing)?
Featured snippet answer: Finished-dose sotorasib tablets are manufactured by qualified drug product manufacturers under Amgen’s CMC and quality oversight for KRAZATI distribution.
Which dosage form is involved and why it narrows suppliers?
- KRAZATI is marketed as oral tablets. Tablet manufacturing requires:
- consistent particle size and flow for a small-molecule API
- impurity control through granulation and compression parameters
- validated dissolution performance under fixed specifications
These constraints usually narrow qualified CDMO availability compared with simpler capsule formats.
How does Amgen manage sotorasib supplier qualification and release testing?
Featured snippet answer: Amgen retains control over regulatory filings and product release under its quality system, with CDMOs executing manufacturing steps under agreed quality agreements.
What qualification steps block new suppliers
- site qualification and cGMP readiness audits
- process validation and comparability
- method transfer for HPLC, dissolution, and impurity profiling
- stability initiation and ongoing OOS/OOT remediation capability
What does the Orange Book list for Krazati that can reveal suppliers?
Featured snippet answer: The U.S. Orange Book lists FDA-approved drug products and patent/exclusivity data. Supplier-identifying manufacturing partners are typically not deterministically listed there; they are more often tied to labels, CMC filings, and DMF references.
Where supplier names usually appear (high-signal sources)
- product labeling “manufactured for” / “manufactured by” statements tied to NDC labels
- FDA CMC sections and DMF acknowledgements linked to the application
- inspection histories and Establishment Registration and Listing data (when mapped to manufacturing steps)
What generic entry risks change when suppliers are constrained for sotorasib?
Featured snippet answer: Limited, tightly controlled supply chains increase practical barriers for early generic or follow-on supply if manufacturing slots are scarce or tech transfer timelines are longer than expected.
Timing effects
- API availability can delay generic commercialization even if patents and exclusivity timelines allow entry.
- Finished-dose manufacturing slot constraints can shift launch schedules, impacting market share capture windows.
What supplier documentation supports licensing or procurement decisions for sotorasib?
Featured snippet answer: For high-stakes licensing, procurement, and litigation readiness, suppliers should be evidenced through:
- labeled drug product manufacturer statements by NDC
- DMF-linked API manufacturing references
- executed quality agreements and change-control history supporting comparability
Key Takeaways
- Sotorasib supply is Amgen-controlled through CMC filings and quality oversight; API and tablet manufacturing are executed by qualified partners under regulatory constraints.
- Supplier identification at the company level normally requires label/NDC-specific manufacturer statements and DMF/CMC-linked manufacturing references; without those identifiers, the supplier list cannot be stated accurately to a litigation-grade standard.
- Supplier constraints influence both continuity of supply and follow-on entry feasibility, even when exclusivity and patent barriers are time-based.
FAQs
- Can a CDMO switch sotorasib API sources without regulatory bridging?
- Which CMC changes most often trigger comparability work for sotorasib tablets?
- How do DMFs for sotorasib API affect who can supply the market?
- Does Krazati labeling name the tablet manufacturer by NDC lot?
- What lead times matter most for sotorasib API versus tablet bulk and finished goods?
References (APA)
- U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
- U.S. Food and Drug Administration. (n.d.). Drugs@FDA. FDA.
- FDA. (n.d.). Labeling and drug product information for KRAZATI (sotorasib). FDA.
