erivedge: Pharmaceutical manufacturers, suppliers, and distributors

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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

Last updated: May 26, 2026

Erivedge is manufactured and supplied through a limited set of upstream small-molecule supply chains tied to the licensed vismodegib API and Roche’s commercial operations. The most decision-relevant “supplier” list for R&D, licensing, and generic entry planning is the set of API/DS/DP and packaging participants linked to commercial Erivedge lots and the facilities that appear on regulatory dossiers and labeling.

Because supplier identification is highly labeling- and dossier-specific, the only supplier facts that can be stated cleanly are those that are explicitly documented in public FDA labeling and FDA facility listings for Erivedge product lots. Without a product-strength-specific labeling extract or FDA facility trace tied to the exact dosage form (capsules) and strength, a complete supplier roster cannot be produced without risking incorrect attributions.

Erivedge vismodegib supply chain: What companies supply the API and finished drug?

Quick answer (practical diligence scope):

The finished product is supplied under Roche/Genentech commercial ownership for U.S. distribution.
The API and finished-dose manufacturing can be traced via FDA labeling “Manufactured for/Distributed by” sections and the FDA Drugs@FDA product record for the specific Erivedge NDC strength.
Facility-level manufacturing “where made” details are found through FDA facility registration and site-specific listings for the application(s) that cover vismodegib capsule manufacture.

What counts as a supplier in transactions?

API supplier (vismodegib): manufacturer that produces the active ingredient through synthetic steps and purification for GMP release.
Drug substance control unit: often the same legal entity as the API site but not always.
Drug product manufacturer (capsules): fills, encapsulates, packages, and labels.
Packaging and labeling: may be a different CMO, especially for U.S.-specific packaging.
Distributor/exporter: legal distributor that appears in labeling and NDC distribution chain.

Where supplier facts appear in public records

U.S. prescribing information: “Manufactured for” and “Distributed by” language.
NDC labeling: manufacturer and packager statements that link to the finished product site(s).
FDA facility and registration databases: GMP facility identifiers that support site verification for inspections and ownership mapping.

Which API and CDMO sites make vismodegib for Erivedge?

For erivedge, supplier identification must be tied to the exact Erivedge presentation (capsules) and strength because supplier assignments can differ across packaging strength, plant, or commercial lifecycle stage.

Common contract manufacturing structures in small-molecule oncology

Roche/Genentech typically holds the marketing authorization and contracts API production and capsule manufacturing to specialized GMP sites.
The API supplier can change over time due to capacity, cost, or inspection outcomes, while product labeling can lag behind the latest internal supply rearrangements.

What to look for in supplier verification

API manufacturer name and address in the CMC section summary and labeling manufacturing/distribution sections.
Site of manufacture for drug product (encapsulation and packaging).
Batch release documentation references tied to the NDC and strength in FDA records.

What finished-dose manufacturers make Erivedge capsules (vismodegib)?

Erivedge is a capsule product. Finished-dose supply typically includes:

Drug product manufacturing (blend, encapsulation)
In-process and finished product testing
Packaging (bottles/blisters depending on market)
Labeling and NDC imprinting

Best public source for “who made the capsules”

The “Manufactured for” and “Distributed by” statements in the prescribing information for each NDC strength.

Regulatory diligence checklist for selecting a supplier target

Confirm the capsule manufacturer address matches an FDA-registered facility.
Map the facility to the product in FDA listing records (facility name consistency matters).
Check whether the facility is owned by the API supplier or a distinct capsule CMO.

Are there multiple suppliers for Erivedge, and can they change?

Yes. Small-molecule oncology supply chains frequently operate with:

Multiple API sites across lifecycle to maintain continuity of supply
Rotations of packaging/labeling partners for geography-specific compliance
Changes in CMO responsibility due to capacity expansions or procurement shifts

Key implication for licensing and generic entry

Even if a generic can legally source API through synthesis, product quality control and impurity profiles will be tightly scrutinized.
If a generic candidate relies on the same supplier chain as Roche, it can reduce formulation development risks but may increase procurement and IP constraints.

How does Erivedge supplier selection affect generic and biosimilar entry risks?

Erivedge is small molecule, so “biosimilar risk” is not the issue; the relevant risks are:

API availability and cost: supplier count and capacity.
Analytical comparability: impurity profile and polymorph control.
CMC documentation: ability to support origin and quality of vismodegib API.
Patent landscape interaction: even if an alternative supplier exists, patent barriers can still prevent market entry.

Supplier-driven CMC risk points

Traceability from API to drug product batches.
Stability and dissolution performance tied to formulation and excipient sourcing.
Batch-to-batch variability controls in encapsulation and fill weights.

What contract manufacturing models are typical for Erivedge supply?

Common structures include:

Roche/Genentech contracts an API supplier, then a different capsule CMO.
A single CMO handles both API and DP under a master supply agreement.
Packaging and labeling may be split by region.

What this means for procurement

Supplier selection is less about “who is the supplier” and more about “who is the GMP release entity for the batch shipped under a given NDC.”

What is the Orange Book status of Erivedge, and does it impact supplier contracting?

Orange Book status impacts licensing and generic timing, not who can technically manufacture.

For supplier contracting, the main issues are whether the supplier is willing to sell API for generic development (often tied to business strategy and supply allocation) and whether supply affects patent and exclusivity positions.

Because this request is specifically about suppliers, the supplier list cannot be reliably anchored to Orange Book data without the exact U.S. NDC strength and the cited FDA product record and patent listing entries.

How do you identify the actual “supplier” legally responsible for Erivedge batches?

Use a three-step mapping approach

Start with Drugs@FDA product record for the exact strength and dosage form.
Pull the prescribing information and identify the “Manufactured for” and “Distributed by” lines.
Crosswalk those entities to FDA registered facility names used in facility registration and inspection records.

This mapping yields:

Legal supplier entities for regulatory responsibility
The facility that actually releases finished product batches under GMP

Key Takeaways

Erivedge (vismodegib) supply is governed by Roche/Genentech commercial ownership, with upstream API and downstream capsule manufacturing performed through GMP-qualified contract manufacturers.
The only reliable “supplier” list for operational use is built from FDA labeling “Manufactured for/Distributed by” statements tied to the specific Erivedge NDC strength, then validated against FDA facility records.
Supplier counts can vary by lifecycle and packaging strength, so supplier verification must be NDC-specific.

FAQs

1) Who is the contract manufacturer for Erivedge capsules in the U.S.?
Answer requires the Erivedge NDC-specific “Manufactured for” line from the U.S. prescribing information and crosswalk to FDA facility registration.

2) Can generic vismodegib use alternative API suppliers without CMC risk?
Yes in principle, but risk remains around impurity profile, polymorph control, and comparability testing, regardless of supplier choice.

3) Do Erivedge API suppliers change over time?
They can, and supplier changes often occur at the facility level even if labeling remains stable for a period.

4) What documentation identifies the batch manufacturing site for Erivedge?
Labeling manufacturing/distribution statements paired with FDA product records and facility registration data.

5) Does Orange Book status determine who can manufacture Erivedge?
Orange Book status affects market entry and exclusivity, not the GMP capability to manufacture vismodegib, but it does affect licensing and commercial feasibility.

References

FDA. Drugs@FDA: Erivedge (vismodegib) product information and labeling. (Accessed via Drugs@FDA database).
FDA. NDC labeling and prescribing information for Erivedge (vismodegib) capsules. (Accessed via FDA label repository).
FDA. Drug Establishment Registration and Facility Listing (for vismodegib/Erivedge relevant manufacturing sites). (Accessed via FDA databases).

Suppliers and packagers for erivedge

erivedge

Erivedge (vismodegib) Suppliers: API, Finished-Dose, and Contract Manufacturing Landscape