Suppliers and packagers for VISUDYNE

VISUDYNE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119	NDA	Bausch Health US LLC	0187-5600-15	1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0187-5600-15)	2000-04-12
Bausch Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119	NDA	Bausch & Lomb Incorporated	24208-560-15	1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (24208-560-15)	2000-04-12

Suppliers for Visudyne (verteporfin) in the US: Who manufactures it, who distributes it, and what supply-chain disclosures matter

Last updated: May 28, 2026

Visudyne (verteporfin) is supplied to the US market as a branded injectable for photodynamic therapy. The supply structure is dominated by the product’s listed FDA-label holder and its commercial distribution channel; upstream “suppliers” for verteporfin drug substance and sterile manufacturing are typically not fully disclosed in the Orange Book. For supply-chain execution, the highest-signal entities are the FDA label/Applicant, the commercial manufacturer, and the authorized distributors listed for drug distribution.

Who supplies Visudyne (verteporfin) in the US market?

Direct supplier in regulated filings: the FDA “applicant”/label holder listed for Visudyne (verteporfin) on the prescribing information and FDA product records controls the branded supply chain, including contract manufacturing and distribution arrangements.

Distribution channel: Visudyne is typically distributed through wholesale distributors that hold authorized pharmaceutical distribution rights for branded injectables. Those entities are the operational “suppliers” for pharmacies and health systems.

H3: How to identify the operational supplier for purchasing and contracting

For procurement, the “supplier” you contract with is usually one of:

• The wholesaler/distributor that lists Visudyne for sale and services account-level fulfillment
• The authorized wholesaler delivering to group purchasing organizations (GPOs)
• The direct-to-institution supplier used by the label holder for tender markets

Orange Book entries can identify the NDA applicant and patent estate but often do not disclose drug-substance vendors.

H3: What Orange Book does and does not tell you about upstream vendors

Orange Book lists patent associations and NDA status, not a bill of materials. Drug-substance and fill-finish suppliers are usually behind:

• NDA manufacturing site disclosures in FDA records
• Label “Manufactured for” language on the carton and vial
• DMF linkage for excipients and manufacturing controls, when publicly indexed

Source: FDA Orange Book and labeling records.

What companies manufacture the Visudyne injectable (verteporfin)?

Visudyne is manufactured as a sterile injectable product. The manufacturing supply chain is split across:

1. Active ingredient (verteporfin) manufacturing (often via contract chemical synthesis and purification)
2. Sterile manufacturing and packaging (drug product manufacturing and aseptic processing)
3. Labeling, kit assembly (where applicable), and distribution logistics

Who manufacturers the drug product: the entity named on the “Manufactured for/Manufactured by” statements in the US prescribing information and package labeling.

Who supplies sterile manufacturing capacity: contract manufacturing sites are common for injectable sterile products; their identity is usually reflected in the labeling or FDA manufacturing site listing.

H3: Where to look in Visudyne labeling for the manufacturer

In Visudyne’s US carton and vial labeling, the manufacturer identity typically appears as:

• “Manufactured for” (label holder) and “Manufactured by” (site) language
• The address of the drug product manufacturer or packaging site

Source: FDA labeling records.

How do authorized distributors supply Visudyne to hospitals and pharmacies?

Authorized distributors supply Visudyne through standard pharmaceutical wholesale distribution. Execution depends on:

• Contract tendering and GPO placement
• Inventory allocation during supply constraints
• UCC and cold-chain handling requirements if applicable to the product’s storage conditions (Visudyne is generally managed as a light-sensitive product per label guidance)

H3: Typical distributor role in a branded injectable supply chain

Distributors generally handle:

• Import/clearance where needed
• Warehousing, inventory rotation, and lot traceability
• Fulfillment to wholesalers, group purchasing networks, and health systems

Source: US wholesale distribution model and FDA distribution expectations; specific distributor identities come from product listing and authorized wholesaler feeds, not Orange Book.

What is the FDA/Orange Book status of Visudyne that affects supplier and supply risk?

Why this matters for “supplier” questions: market exclusivity, patent protection, and regulatory status affect how many firms can legally sell the branded product and whether alternatives or authorized generics are present.

H3: Orange Book status drivers for supply continuity

• If Visudyne has no AB-rated therapeutic equivalents and remains NDA-controlled, branded supply continuity relies on the label holder’s manufacturing and distribution arrangements.
• If additional marketing applications exist (authorized generics or related strengths/forms), suppliers may diversify.

Source: FDA Orange Book.

Who supplies Visudyne outside the US: does the global supplier list change?

Global supply is often fragmented:

• Different regional marketing authorizations can have different label holders and manufacturing sites
• Local distributors for each region handle importation and distribution

If global supply is relevant to your operational footprint, you typically map:

• The marketing authorization holder by country
• The labeled manufacturer by country
• The authorized distribution channels for each market

Source: national regulatory authority labeling and MAH records.

What upstream “raw material” suppliers exist for verteporfin and excipients?

Raw-material sourcing is usually not listed by name in Orange Book and is often only visible through:

• DMF public indices (if any)
• FDA manufacturing disclosure in NDA supplements
• Supplier declarations referenced in inspection records (not consistently public)

Operationally, for verteporfin injectables, upstream suppliers fall into:

• Verteporfin drug-substance chemical manufacturers (often DMF-backed)
• Excipients suppliers used in the sterile formulation and kit components
• Packaging/closure suppliers used for vials, stoppers, and kit assembly

Source: FDA DMF index records and labeling/manufacturing disclosures.

What generic or biosimilar competition affects Visudyne supplier options?

Visudyne is a small-molecule injectable. Generic competition, if any, would generally be driven by:

• ANDA filings and approvals for verteporfin injectable
• Paragraph IV challenges if patents are asserted against generic entry

If no approved generics exist for the relevant NDA/strength, procurement remains tied to the branded product supply.

Source: FDA Orange Book patent listings and ANDA status.

What patent estate structure implies who must supply the product and what entry barriers exist?

The Visudyne patent estate determines whether any new supplier can legally market the same drug product or a close substitute. Barriers typically include:

• Drug substance patents (verteporfin synthesis)
• Drug product formulation/sterility/kit assembly patents
• Method-of-use patents for photodynamic therapy

Source: FDA Orange Book and Orange Book patent listings.

Key takeaways

• The operational “supplier” for Visudyne in the US is the NDA label holder’s distribution chain, executed through authorized wholesalers/distributors.
• The most reliable manufacturer identity comes from Visudyne’s US labeling “Manufactured for/Manufactured by” statements and corresponding FDA product records.
• Upstream verteporfin drug-substance and excipient suppliers are usually not named in Orange Book; they require cross-referencing FDA labeling/manufacturing disclosures and DMF-linked public records.
• Patent and regulatory status determine whether procurement can diversify into approved generic verteporfin injectables; otherwise branded supply continuity is the controlling constraint.

FAQs

1. Where is Visudyne (verteporfin) manufactured according to the FDA label?
   The manufacturing site identity is stated on the Visudyne “Manufactured for/Manufactured by” portions of the US prescribing information and carton labeling.

2. Does the FDA Orange Book list verteporfin raw material suppliers for Visudyne?
   No. Orange Book primarily links patents to an NDA; it does not name upstream drug-substance or excipient suppliers.

3. Which wholesalers can hospitals buy Visudyne from in the US?
   Hospitals buy through authorized pharmaceutical distributors and GPO/contract channels; the specific distributor list is tied to authorized wholesale feeds and product listing systems.

4. Are there generic verteporfin injectables approved that expand supplier options?
   Supplier diversification depends on whether an ANDA has been approved for the relevant strength/presentation and is AB-rated in FDA records.

5. Do patents for Visudyne restrict alternative suppliers beyond the branded label holder?
   Yes. Patent protection in the Orange Book can restrict marketing of competing products that practice the claimed composition, formulation, or methods.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Visudyne/verteporfin listings). US Food and Drug Administration.
2. FDA. Drugs@FDA (Visudyne/verteporfin NDA and labeling records). US Food and Drug Administration.