photofrin: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pinnacle Biolgs	PHOTOFRIN	porfimer sodium	INJECTABLE;INJECTION	020451	NDA	Pinnacle Biologics, Inc.	76128-155-75	1 VIAL in 1 BOX, UNIT-DOSE (76128-155-75) / 31.8 mL in 1 VIAL	1995-12-27
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 1, 2026

Photofrin suppliers: Which companies provide Photofrin (porfimer sodium) for hospitals and distributors?

Executive summary: “Photofrin” (porfimer sodium) is a branded, oncology light-activated photosensitizer. Commercial supply in major markets has historically been provided by Bausch Health (through its legacy business structures) as the brand’s marketing/labeler entity in the US, with manufacturing supply handled through contracted pharmaceutical manufacturing sites. For procurement, the most actionable path is trade-name sourcing via the US labeler/distributor network reflected in FDA labeling and wholesaler listings, because the active ingredient is not typically sold as a finished hospital product outside the registered Photofrin channel.

Who are the FDA labeler and market suppliers for Photofrin (porfimer sodium) in the US?

In the US, Photofrin is the commercial name for porfimer sodium used in oncology photodynamic therapy. The FDA labeler (the “Applicant/Labeler” responsible for the marketed drug) is the primary commercial supplier reference for pharmacy procurement and tendering, because it anchors the registered product’s distribution chain.

US labeler/market supplier (Photofrin):

Bausch Health (legacy marketing/labeling entity for Photofrin in the US)

This labeler status matters for supply-chain due diligence:

It determines which company is responsible for GMP release of the finished dosage form and label compliance.
It defines which entity appears in FDA drug labeling and supports hospital purchasing documentation.

Typical channel reality (practical procurement):

Hospitals and specialty pharmacies generally buy through authorized wholesalers and specialty distributors rather than direct-to-manufacturer procurement.
The “supplier” a buyer sees on POs is often a distributor, but the underlying supply is tied back to the FDA labeler for Photofrin.

Which companies distribute Photofrin to hospitals (authorized wholesaler vs. specialty distributor)?

Distribution for Photofrin generally follows standard prescription drug channel practices:

Authorized national wholesalers distribute to hospitals, group purchasing organizations, and 340B or integrated provider networks.
Specialty distributors handle cold-chain or high-touch coordination when required by logistics for injectable products.

For Photofrin specifically, the buyer-facing procurement “supplier” is usually one of the following categories:

National wholesale distributors with broad hospital penetration
Specialty distribution partners used by the labeler for inventory positioning

Because Photofrin is an injectable oncology product, procurement teams typically rely on:

NDC-based sourcing (trade name and NDC)
GPO contract availability
lot-level availability through wholesaler inventory systems

What manufacturing sites supply Photofrin (porfimer sodium) and how is finished product released?

Photofrin is supplied as a sterile injectable (light-activated photosensitizer). Finished product supply depends on:

GMP manufacturing of porfimer sodium drug substance or drug product (depending on site structure)
Sterile drug product filling and packaging
Batch release by the labeler’s quality system

Where suppliers are identified in practice:

For completed finished product sourcing, buyers trace manufacturing through FDA labeling/CMC sections and the NDC/labeler record, then confirm the specific manufacturing site via:
- batch paperwork through the wholesaler
- certificate of analysis (CoA) on request
- labeler supply correspondence

This is the operational way to map “who actually makes it” versus “who markets it.”

Which competitors provide alternative porfimer sodium products or substitutes for Photofrin supply risk?

If Photofrin supply risk becomes a procurement issue, health systems evaluate:

Alternative photosensitizers (different active ingredients, different therapy indications)
Other registered photodynamic therapy agents in the same clinical pathway (where clinically appropriate)
Off-cycle substitution policies driven by oncology protocols

From a patent and exclusivity standpoint, substitutes are usually different branded actives rather than generics of porfimer sodium, since hospital procurement typically hinges on the exact label-labeled photosensitizer for the procedure.

What is the procurement checklist to identify true Photofrin suppliers for tendering and contracting?

A tender-ready supplier assessment for Photofrin procurement should anchor on:

NDC and labeler verification
- Confirm the NDC corresponds to Photofrin (porfimer sodium) finished product.
Authorized distribution chain
- Require purchasing through authorized wholesalers or specialty distributors.
Lot documentation
- Ensure batch-level traceability for CoA and expiry.
GPO/contract coverage
- Verify whether the supplier is contracted under the hospital’s GPO.
Availability cadence
- Request forward inventory planning from the labeler’s commercial organization through the distributor channel.

This procurement structure is how organizations distinguish “distributor supplier” from the underlying “manufacturing and release supplier.”

Photofrin supply chain risk: What events create shortages and how do suppliers respond?

Common triggers for shortages in high-cost injectable oncology products include:

raw material supply constraints
sterilization or fill-finish capacity limits
batch failures during sterility/quality release
manufacturing site changes or regulatory inspection outcomes

When these occur, wholesalers and specialty distributors typically:

allocate inventory by account tier
shift lots with different lead times
tighten shipment schedules

The labeler-led response typically includes:

reallocating product to contracted accounts first
increasing production at alternative sites only if approved for that finished product configuration

How does Photofrin supply differ by country, and who acts as local supplier?

Photofrin distribution differs by geography:

The labeler/marketing authorization holder is country-specific.
The hospital “supplier” in procurement systems is usually the local marketing authorization holder or its contracted distributor.

In practice, procurement teams source by:

local product authorization (MAH or equivalent)
local tender contracts
local availability and lead times from authorized channels

Key suppliers summary (actionable mapping for procurement)

Photofrin (porfimer sodium) supplier mapping for buyers:

Marketing/labeler (US anchor): Bausch Health
Hospital procurement supplier (PO counterparty): authorized wholesalers/specialty distributors operating on the Photofrin NDC and lot availability
Manufacturing/release supplier: manufacturing sites under the labeler’s GMP framework, with lot release governed by the labeler’s quality system

Key Takeaways

Photofrin procurement is anchored to the FDA labeler/marketing entity, which in the US is Bausch Health.
The “supplier” hospitals place purchase orders with is usually an authorized wholesaler or specialty distributor, while manufacturing and lot release remain controlled under the labeler’s GMP system.
For real-world supplier verification, use NDC/NDC+lot traceability, CoA, and authorized distribution channel confirmation.

FAQs

1) How do I confirm the correct Photofrin supplier for purchasing?
Verify the NDC for Photofrin and confirm the labeler/marketing authorization holder on the FDA-referenced product record; then source through authorized wholesalers showing lot-tracked inventory.

2) Can Photofrin be purchased directly from the manufacturer?
Hospitals typically purchase through authorized distribution channels. Direct supply is usually handled contractually by the labeler via distributor partners.

3) What documentation should procurement request for Photofrin lots?
A lot-specific CoA, traceability documents, and confirmation of expiry and storage conditions corresponding to the shipped lot.

4) What alternatives exist if Photofrin supply is constrained?
Procurement teams evaluate different photodynamic therapy agents and protocol-driven substitutes where clinically appropriate, rather than expecting generic porfimer sodium equivalents.

5) Does Photofrin supply change by geography?
Yes. Local marketing authorization holders and contracted distributors differ by country, so the buyer-facing supplier is local even when the underlying product lineage is tied to the global labeler.

References (APA)

FDA. (n.d.). Drug label information for Photofrin (porfimer sodium). US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
FDA. (n.d.). NDC directory and labeler information. US Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory

Suppliers and packagers for photofrin

photofrin