PAFOLACIANINE SODIUM: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907	NDA	On Target Laboratories, Inc.	81052-138-10	10 CARTON in 1 CARTON (81052-138-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1.6 mL in 1 VIAL, SINGLE-DOSE (81052-138-01)	2021-11-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

Suppliers for Pafolacianine Sodium (Oncology Imaging): Manufacturers, Contrast-Formulation Sources, and Supply Risk

Pafolacianine sodium is used as a diagnostic imaging agent in oncology (PET/fluorescence context). It is sourced through a small number of qualified specialty suppliers that provide either the active pharmaceutical ingredient (API) or finished diagnostic product for licensed distribution channels. Supply access depends on intended use (research reagent vs clinical diagnostic supply), regulatory status, and whether the vendor supplies API, drug product, or both.

Who supplies pafolacianine sodium API for pharmaceutical manufacturing?

Primary supplier routes

API suppliers: vendors manufacturing pafolacianine sodium API (or advanced intermediates) for contract manufacturing organizations (CMOs) and diagnostic manufacturers.
Finished-dose diagnostic suppliers: vendors providing the formulated imaging product under NDA/IND/clinical supply arrangements.
Reagent suppliers (non-cGMP): research-grade distributors sometimes carry pafolacianine sodium for assay development and preclinical imaging workflows, usually without the documentation package expected for regulated manufacturing.

Supply reality for rare oncology imaging agents Pafolacianine sodium is not widely stocked like mainstream small-molecule APIs. Commercial availability is typically through:

qualified specialty manufacturers supplying to diagnostic product makers, and
regional distributors with temperature-controlled logistics and documentation support.

Which companies manufacture pafolacianine sodium for clinical use?

Clinical supply pattern

Clinical imaging agents typically come through vendors that already support regulatory-grade manufacturing, including batch records, CoA, and stability documentation.
For imaging diagnostics, manufacturers frequently coordinate labeling, packaging, and cold-chain distribution rather than selling raw API at scale.

What to look for in a clinical supplier

Supply chain capability for sterile/aseptic handling (if the drug product is sterile).
Documentation package consistent with:
- GMP manufacturing and CoA release,
- traceability for raw materials,
- stability data for shelf life/handling.

Are there multiple global suppliers of pafolacianine sodium, or is it single-source?

Single-source risk is common For niche diagnostic agents, supply is often concentrated. Practical indicators of concentration:

limited public procurement listings,
short list of vendor-qualified CMOs,
supplier documentation requiring qualification steps.

Operational implication Procurement for diagnostic manufacturing should assume:

a constrained vendor base, and
qualification lead times tied to cGMP documentation and analytical method transfer.

What documents and quality system requirements do pafolacianine sodium suppliers provide?

Typical supplier deliverables

Certificate of Analysis (CoA) per lot
GMP status statement (for cGMP supply)
Analytical profile (purity, identity, related substances)
Particle size and residual solvent data (if applicable to formulation process)
Stability protocol and trend data for shelf-life assignment
Change control and impurity fate-of-variation statements (for process changes)
Sterility/endotoxin documentation if supplied as drug product

Regulatory-ready QA pack A regulated purchaser expects:

controlled specifications,
validated analytical method summaries or at minimum method descriptions,
traceability for critical raw materials.

What is the difference between pafolacianine sodium API suppliers and imaging drug-product suppliers?

API suppliers

deliver bulk active compound with analytical release specs
support CMO or manufacturer formulation into drug product
require the buyer to handle formulation, fill-finish, sterility assurance (if needed), and regulatory filing elements

Drug-product suppliers

deliver finished imaging agent in final presentation (vial/pack)
take responsibility for manufacturing and quality release of the drug product
simplify regulatory supply chain for the sponsor/manufacturer receiving product

Business consequence API sourcing increases buyer manufacturing scope. Drug-product sourcing reduces integration burden but typically carries higher unit cost and tighter forecast commitments.

What formulations are typically supplied for pafolacianine sodium (vial presentation, concentration, stability)?

Common supply format characteristics for imaging agents

single-use vials
controlled concentration suitable for imaging workflows
packaging designed for cold-chain or controlled temperature storage

Supplier-specific differences Even when both supply “pafolacianine sodium,” vendors can differ in:

salt form quality profile and polymorph/particle characteristics (if applicable)
excipient system (buffers, stabilizers)
fill size and overfill strategy
handling instructions and stability claims

How do you evaluate pafolacianine sodium supplier reliability for IP, audit, and regulatory submissions?

Evaluation criteria that matter in practice

Regulatory track record: prior support for imaging/diagnostic manufacturing and successful audits
Audit readiness: ability to respond to QA due diligence within procurement timelines
Method transfer support: analytical cross-walk capability for identity/purity panels
Change control discipline: visibility into formulation and process changes
Right-to-audit: contractual audit access for batch release decisions
Contingency planning: documented second-source or hold-time strategy

Why this matters Imaging agents are frequently time-sensitive for clinical studies and require predictable release schedules. Supplier instability delays patient dosing schedules and can trigger protocol amendments.

What procurement channels exist for pafolacianine sodium (direct, distributor, CMO-qualified)?

Channel map

Direct manufacturer-to-buyer
- fastest for qualification, best documentation control
Distributor
- faster lead times for small quantities
- may add friction for audit requests depending on documentation access
CMO-qualified procurement
- buyer contracts a CMO that already has supplier qualification for pafolacianine sodium
- lowers buyer qualification burden, increases lock-in to CMO’s supplier list

What generic entry risks exist for pafolacianine sodium suppliers?

Non-traditional for “generic” Pafolacianine sodium is a diagnostic agent. Competitive entry risks depend on:

whether it is protected as a proprietary formulation/presentation,
whether method-of-use or formulation patents exist,
whether supply is bottlenecked by qualification requirements rather than patent barriers.

Supplier impact Even if a competitor can source API, regulatory-grade drug product manufacture may still be the gating factor due to:

aseptic/sterility assurance and stability qualification,
analytical method validation,
supply chain cold-chain compliance.

What patent/IP constraints affect sourcing or substitution of pafolacianine sodium?

Typical constraint classes

API process patents impacting impurity profiles and allowed manufacturing routes
formulation patents protecting excipient systems or concentration ranges
device-imaging integration patents (if tied to imaging workflow)

Sourcing consequence Suppliers may restrict sales to avoid implication in protected manufacturing methods or proprietary specifications that do not align with a buyer’s planned product.

(Patent landscape details require the specific proprietary product name, NDA/ANDA identifier, and jurisdiction-specific assignments, which are not provided in the prompt.)

Key Takeaways

Pafolacianine sodium supply is typically concentrated in a small number of specialty vendors that can support regulated documentation and quality release.
Supplier options usually split into API sourcing (for buyers with formulation/fill-finish capability) and finished drug-product sourcing (for sponsors needing ready-to-use clinical supply).
The procurement decision should prioritize cGMP documentation, audit readiness, analytical method support, and cold-chain logistics over price.
For diagnostics, the practical barrier to entry is often qualification and manufacturing release predictability rather than API availability alone.

FAQs

Is pafolacianine sodium available from mainstream API distributors?
Supply is generally specialist-led; mainstream catalog availability is often limited.
What documentation should a buyer require from pafolacianine sodium suppliers?
CoA, GMP/cGMP status, analytical release specs, traceability, and stability data for regulated supply.
Do pafolacianine sodium API and drug-product suppliers differ in qualification timelines?
Yes. API qualification typically adds formulation and fill-finish timelines for the buyer.
How do cold-chain requirements affect supplier selection for pafolacianine sodium?
Temperature handling and stability limits drive packaging choice and can constrain vendor logistics.
What are the most common reasons for supply delays with niche diagnostic imaging agents?
Batch release hold due to analytical deviations, limited capacity, and qualification/QA documentation bottlenecks.

References

(No sources were provided in the prompt.)

Suppliers and packagers for generic pharmaceutical drug: PAFOLACIANINE SODIUM