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Suppliers and packagers for generic pharmaceutical drug: Vismodegib
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Vismodegib
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Genentech | ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388 | NDA | Genentech, Inc. | 50242-140-01 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-140-01) / 28 CAPSULE in 1 BOTTLE, PLASTIC | 2012-01-30 |
| Genentech | ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388 | NDA | Genentech, Inc. | 50242-140-86 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-140-86) / 28 CAPSULE in 1 BOTTLE, PLASTIC | 2012-01-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: Vismodegib
Vismodegib suppliers: who manufactures and sells supplies of GDC-0449 (Erivedge) active ingredient and finished product?
Vismodegib supply chains split into (1) API and (2) finished-dose drug product supply for the branded capsule product (Erivedge, 150 mg). Publicly indexed supplier details depend on whether the user needs commercial finished product sourcing or API procurement. In the United States, Vismodegib is marketed as Erivedge capsules; branded supply is typically handled by the marketing authorization holder and its commercial manufacturing network, while API is sourced from specialized chemical manufacturers and contract API sites.
What follows is a supplier map of the commercial ecosystem for vismodegib based on publicly disclosed manufacturing and commercial supply roles.
Who supplies vismodegib (Erivedge) finished capsules to the market?
Answer (market role split):
- Marketing authorization holder / brand owner: Genentech, Inc. (Erivedge is marketed in the US under the Genentech brand organization).
- Commercial manufacturing and product supply: the commercial capsule manufacturing network supporting Erivedge is typically executed via Genentech’s contracted CDMO and drug-product sites, with distribution through Genentech-affiliated channels.
Practical implication for procurement: finished-dose sourcing is usually controlled at the brand supply level unless a distributor sources from specific lots. Direct “supplier of record” for a given lot is generally traceable via lot-specific documentation and distribution records, not a single static entity name.
What are the key finished-dose packaging formats and strengths that affect supplier scope?
- Dosage form: capsules
- Strength: 150 mg
- Supplier scope differs by: capsule fill-finish site, bottling/packaging facility, and commercial distribution warehouse
Who manufactures the vismodegib API (GDC-0449) for pharmaceutical supply?
Answer (API supply):
- Vismodegib API is produced by specialized small-molecule API manufacturers and contract synthesis organizations supporting brand and generic supply chains.
- API supply is not limited to one manufacturer globally. Multiple suppliers may support clinical, commercial, and regional distribution demands.
Why API supplier identification is fragmented
- Vismodegib is a complex small molecule (Hedgehog pathway inhibitor) with multi-step synthesis.
- API supply contracts typically vary by geography, lot availability, and regulatory strategy.
- Patent and regulatory documentation are usually where manufacturing-site names appear, while general supplier databases often list only the branded drug entity.
Procurement lens for API buyers
For API procurement, the supplier list is best evaluated by:
- DMF holder(s) and approved manufacturing sites (US and other regions)
- GMP certificate coverage and inspection history tied to the specific API site
- Lot release testing capability (impurities and residual solvents)
- Regulatory suitability for intended market (US vs EU vs ROW)
Which companies have been linked to vismodegib manufacturing or supply roles?
Answer (publicly linked ecosystem roles):
- Genentech is the brand owner and directs commercial supply for Erivedge in the US.
- Contract manufacturing organizations (CMOs) and API manufacturers supply the upstream drug substance and the finished-dose capsule manufacturing network.
Commercial procurement reality: you rarely buy “direct” API from the brand owner. You source through approved intermediaries or via direct API vendor qualification against the relevant regulatory filings for vismodegib.
What do DMF holders and approved manufacturing sites imply for supplier selection?
Answer (regulatory gatekeeping):
- The practical “supplier list” for an API is constrained by US FDA DMF coverage and site approvals that align with commercial demand and regulatory filings.
- API sites are approved through the regulatory pathway that references the DMF and the drug master file cross-reference strategy (or the relevant national submissions in other markets).
Supplier selection criteria for vismodegib API
- DMF-referenced site authorization
- CoA and impurity profile alignment with the relevant specification
- Consistency in polymorph/solid-state form control
- Scalability and supply continuity for production schedules
When do generic or alternative supply opportunities affect vismodegib procurement?
Answer (procurement timing):
- Vismodegib’s commercial supply is driven by branded access until a meaningful regulatory and patent clearance event enables generics or other competitors to sell the drug substance and finished product.
What to watch for
- FDA Orange Book entries tied to Erivedge (drug product patents and exclusivity)
- Paragraph IV filings (if any) that create generic launch timelines
- Settlement agreements that delay entry
- Exclusivity blocking mechanisms such as patent term adjustment or additional exclusivities for specific change types
How does vismodegib supplier risk differ by API vs finished-dose sourcing?
API sourcing risk:
- GMP and inspection outcomes at the API site
- Multi-step synthesis bottlenecks and impurity control risks
- DMF cross-reference limitations
Finished-dose sourcing risk:
- Capsule fill-finish capacity and packaging material constraints
- Lot release delays
- Variability in distributor warehouse stocking
How do you map vismodegib suppliers to regulatory filings in the US?
Answer (mapping method):
- Start with the Orange Book listing for Erivedge to identify patent-protected elements and the reference listed drug.
- Then cross-reference FDA DMF and manufacturing-site information for the drug substance and the finished dosage.
- For non-US regions, map analogously through local regulatory submissions (EMA/National) and DMF equivalents.
Procurement deliverable: a supplier eligibility matrix by market, dosage form, and DMF-referenced site.
Key Takeaways
- Finished-dose vismodegib supply is controlled by the brand owner (Genentech) and its commercial capsule manufacturing network for Erivedge 150 mg.
- API supply is handled by specialized API manufacturers and contract synthesis/CMO sites tied to DMF-supported manufacturing approvals.
- Supplier identification for vismodegib is typically lot- and site-specific and is best grounded in FDA Orange Book + DMF-referenced manufacturing sites rather than broad “supplier lists.”
- When planning sourcing, split the work between API site qualification and finished-dose packaging/lot release qualification.
FAQs
1) Who is the brand owner of Erivedge (vismodegib) in the US?
Genentech.
2) What is the marketed dosage form and strength for vismodegib?
Capsules, 150 mg.
3) How do I identify the approved vismodegib API manufacturing sites?
Use FDA DMF-referenced manufacturing site information tied to the relevant Erivedge regulatory submissions.
4) What document set best supports qualification of a vismodegib API supplier?
DMF cross-reference and GMP evidence for the exact manufacturing site plus CoA and impurity/spec conformance.
5) Do finished-dose suppliers match API suppliers for vismodegib?
Not necessarily. Drug product capsule manufacturing and packaging sites often differ from the API synthesis sites.
References (APA)
- Genentech, Inc. Erivedge (vismodegib) prescribing information. (Latest available version on file).
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Erivedge, vismodegib). U.S. Food and Drug Administration.
- FDA. Drug Master Files (DMF) database and DMF-referenced manufacturing information for vismodegib (GDC-0449). U.S. Food and Drug Administration.
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