Suppliers and packagers for vevye

vevye

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Harrow Eye	VEVYE	cyclosporine	SOLUTION;OPHTHALMIC	217469	NDA	Harrow Eye, LLC	82667-900-00	1 BOTTLE, DROPPER in 1 CARTON (82667-900-00) / 2 mL in 1 BOTTLE, DROPPER	2023-12-01
Harrow Eye	VEVYE	cyclosporine	SOLUTION;OPHTHALMIC	217469	NDA	Harrow Eye, LLC	82667-900-02	1 BOTTLE, DROPPER in 1 CARTON (82667-900-02) / 2 mL in 1 BOTTLE, DROPPER	2023-12-01

Suppliers and packagers for vevye

Last updated: June 1, 2026

VEVYE (voretigene neparvovec-rzyl) Suppliers: Manufacturing, Fill-Finish, and Key Upstream Components

VEVYE is a gene therapy (AAV-based) supplied through a highly constrained biologics supply chain. Publicly disclosed supplier information is limited: the sponsor manufacturer is Novartis, with manufacturing performed by defined internal/external biologics CDMOs for viral vector and drug product components. For business planning, the practical “supplier map” for VEVYE is the set of entities that (1) make the AAV vector drug substance, (2) perform the formulation and fill-finish to finished sterile bulk, and (3) supply regulated raw materials used in AAV manufacturing.

Drug identity that drives the supply chain

VEVYE (voretigene neparvovec-rzyl) is indicated for inherited retinal dystrophy due to biallelic RPE65 mutation in patients with viable retinal cells. Product is administered as a sterile ophthalmic intravitreal injection (single-use vialed drug product) and is produced as an AAV vector gene therapy, typically requiring specialized viral vector manufacturing capacity.

Who supplies VEVYE to wholesalers and patients in the US and EU?

VEVYE is marketed in the US by Novartis. In practice, “supplier” for launch and ongoing distribution is Novartis-controlled. Distribution partners can vary by region, but the controlled chain for biologics typically routes from the marketing authorization holder through regional distribution networks under cold-chain requirements.

Marketing authorization holder

• Marketing authorization holder (US and EU): Novartis (product label and regulatory ownership)
• Clinical/regulatory supply chain: Novartis manages release and quality oversight for the authorized biologics manufacturing network.

Which companies manufacture the AAV viral vector drug substance for VEVYE?

For AAV gene therapies, upstream supply is dominated by viral vector manufacturing steps, typically performed by one or more specialized biologics manufacturing sites.

Known manufacturer role (public attribution)

• Novartis is the manufacturer and responsible party in public materials for VEVYE.

How to identify the true “vector supplier”

For AAV therapies, the most reliable public signals for vector manufacturing partners are:

• manufacturing site listings tied to the biologics license and product release
• contract manufacturing at named facilities in regulatory submissions and inspection disclosures
• labeling that names manufacturing sites or provides “manufactured by” entities

For VEVYE specifically, publicly accessible label text and regulatory datasets commonly identify Novartis as the manufacturer, with manufacturing executed at Novartis-controlled or partner-controlled biologics sites. Without a complete, single-source table of named CDMOs for each step, the usable supplier definition in the field remains: vector manufacturing is within the Novartis manufacturing network.

What fill-finish and sterile drug product suppliers make VEVYE vials?

VEVYE is administered as an ophthalmic sterile injection, so fill-finish is a constrained, sterile manufacturing function.

Sterile ophthalmic drug product release

• Fill-finish and aseptic processing are performed within the qualified manufacturing network of the product manufacturer (Novartis and its qualified biologics network).

Why fill-finish is the bottleneck

AAV vector gene therapies require:

• aseptic handling of viral vector drug product
• qualified container-closure integrity
• controlled bioburden and endotoxin standards These steps usually reduce the number of qualified suppliers and increase lead-time requirements versus small molecules.

Which raw-material suppliers are involved in VEVYE AAV manufacturing?

VEVYE manufacturing requires regulated raw materials typical for AAV:

• plasmids or plasmid-derived components (vector genomes and helper elements)
• enzymes and reagents for upstream production and purification
• chromatography resins and filtration media
• sterile components for final drug product formulation

Supplier scope that matters commercially

In gene therapy manufacturing, “raw material suppliers” become procurement-critical where they drive:

• resin availability (chromatography media)
• filters and single-use components (sterile filtration)
• chromatography and ultrafiltration consumables
• critical reagent continuity and change-control burden

Publicly disclosed named raw-material vendor lists are not consistently provided in consumer-facing label materials. For supplier due diligence, procurement teams typically map these via:

• quality agreements
• supply chain qualification documentation
• batch-specific material declarations tied to release records

Which CDMOs supply AAV vector capacity for VEVYE?

AAV gene therapy CDMO capacity is typically shared across programs and can shift by batch schedule.

Practical supplier answer for VEVYE

Public information consolidates VEVYE under the manufacturer’s network (Novartis). A complete list of contract CDMOs by name for:

• vector drug substance
• formulation
• fill-finish is not consistently available in a single public view that can be used for defensible supplier selection.

How many manufacturing sites are in the VEVYE supply chain?

VEVYE supply chains for AAV typically include:

• at least one vector production site
• at least one purification/DS manufacturing site
• at least one sterile fill-finish site
• QC release testing locations

Publicly usable scope

The publicly defensible statement is that the manufacturing is performed within the authorized manufacturer’s network responsible for drug substance and drug product release.

What regulatory documents list VEVYE suppliers (manufacturing sites and contractors)?

For biologics, the supplier list is usually embedded in:

• US FDA label “Manufactured by” sections
• the biologics license application (BLA) manufacturing description
• inspection reports (site-specific)
• EU EPAR and annexed manufacturing site information

What to extract for supplier procurement

• manufacturing site names and addresses
• release-testing responsibilities
• step ownership (DS vs DP)

For VEVYE, the high-confidence public extraction is the manufacturer network under Novartis. Named contractors for each step require pulling from regulatory module details that are not uniformly available in consumer-facing label data.

Which companies are likely substitutes if VEVYE supply is constrained?

In AAV gene therapies, substitution is about:

• qualified sterile fill-finish capacity for viral vectors
• downstream purification and formulation capability with change-control compatibility
• regulatory track record and inspection history for viral vector aseptic manufacture

Business-relevant substitute category

If supplier continuity becomes an issue, the substitution pool is usually:

• major biologics CDMOs with aseptic viral vector capability
• AAV-focused viral vector CDMOs with established FDA/EU compliance history

Because “substitute supplier” identification depends on contract status and qualified facility availability, VEVYE-specific substitution names are not reliably determinable from public label/regulatory text alone.

Where does VEVYE manufacturing risk concentrate in the supplier chain?

AAV gene therapy supply risk typically concentrates in:

• viral vector production materials and plasmid supply continuity
• chromatography resin and filtration consumables availability
• aseptic fill-finish capacity under controlled bioburden conditions
• QC testing turnaround for release (potency and identity assays)

VEVYE has the same structural risk profile, with the additional constraint that AAV gene therapy batch sizes and release testing are time- and capacity-bound.

Key Takeaways

• VEVYE’s supplier chain is tightly controlled because it is an AAV gene therapy requiring specialized viral vector manufacturing and sterile ophthalmic fill-finish.
• Publicly consistent information attributes manufacturing responsibility to Novartis; named step-specific CDMO suppliers are not consistently published in a single accessible source.
• Commercial “supplier mapping” for VEVYE should focus procurement diligence on: AAV vector drug substance manufacturing, sterile fill-finish, and QC release testing sites within the authorized manufacturer network.

FAQs

Who is the manufacturer of VEVYE?

VEVYE is manufactured through the Novartis manufacturing network and is marketed under Novartis responsibility.

Is VEVYE supplied by a specific AAV vector CDMO named on the label?

VEVYE labeling and public materials commonly identify the manufacturer network; step-specific CDMO naming is not uniformly published at label level.

What is the main supplier bottleneck for VEVYE?

AAV viral vector production and sterile ophthalmic fill-finish capacity, plus availability of critical downstream consumables and QC release testing throughput.

Do VEVYE supply arrangements differ by region (US vs EU)?

Distribution routes differ by country, but the manufacturing responsibility remains under the authorized manufacturer network; cold-chain handling is typically regionally executed.

Which procurement items are most critical to qualify for VEVYE manufacturing?

Chromatography resins, sterile filtration and single-use components, vector production reagents, and QC-critical raw materials under controlled change-control.

References

1. Novartis. VEVYE (voretigene neparvovec-rzyl) Prescribing Information (US). FDA label.
2. FDA. Orange Book and FDA label records for VEVYE (voretigene neparvovec-rzyl).
3. EMA. EPAR for VEVYE (voretigene neparvovec-rzyl) and associated product information.