Suppliers and packagers for VALCHLOR

VALCHLOR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317	NDA	Helsinn Therapeutics (U.S.), Inc.	69639-120-01	1 TUBE in 1 CARTON (69639-120-01) / 60 g in 1 TUBE	2018-11-08

Valchlor suppliers: What manufacturers make valrubicin and who supplies the clinical and commercial supply chain

Last updated: May 23, 2026

Valchlor (valrubicin) is supplied as a packaged, ready-to-use product for intravesical administration. The supplier set is defined by (1) the NDA product manufacturer(s) and (2) the contract manufacturing and packaging vendors shown in FDA product records and commercial distribution listings, with the active pharmaceutical ingredient (API) sourced from specialized chemical manufacturers. The relevant supplier entities are determined from FDA labeling, Orange Book listings, and FDA facility records tied to the NDA product.

Who makes Valchlor (valrubicin) and what company supplies the drug product?

Valchlor’s drug product supplier is the NDA holder’s manufacturing network as listed for the commercial product in FDA records and the product label. The drug is not distributed as a generic commodity; instead it is supplied as a finished, packaged intravesical dosage form, with manufacturing and packaging performed at specific FDA-registered facilities tied to the NDA.

What facilities are shown for Valchlor manufacturing and packaging?

FDA facility registrations and product listings typically separate:

• Drug substance (API) sites: valrubicin chemical manufacture
• Drug product sites: finished dosage formulation, sterile/non-sterile finishing as applicable, and packaging into the labeled configuration

Which label sections identify Valchlor’s manufacturer?

The Valchlor carton and prescribing information identify:

• Applicant/labeler and US marketing authorization holder
• The “manufactured for” or “distributed by” line
• The manufacturing site address block tied to the NDA

What suppliers provide the Valchlor active pharmaceutical ingredient valrubicin?

Valrubicin API is produced through a specialized chemical synthesis and is then delivered to the NDA holder or its contract manufacturer for formulation into the final intravesical dosage form. Supplier identification in practice is constrained to API manufacturing sites registered with FDA and tied to the NDA submission product and manufacturing profile.

How does API sourcing appear in the US regulatory record?

For supplier due diligence, API supply chains are typically evidenced by:

• FDA drug master file (DMF) references (when used by an NDA holder)
• FDA facility registration under the relevant product category
• Inspection history tied to the facility and the drug substance

What Orange Book listings show about Valchlor suppliers and exclusivity?

Orange Book listings for Valchlor identify:

• NDA number(s)
• Dosage form and strength
• Proprietary name
• Applicant (labeler)
• Patent numbers listed for the NDA

Those fields anchor the supplier identity because the “Applicant” and associated NDA manufacturing information link back to the product’s registered manufacturing facilities.

What patents are listed for Valchlor that affect supply?

Patent listing does not directly list manufacturing vendors, but it affects supply timing:

• Formulation and composition patents tied to valrubicin product manufacture
• Method-of-use patents tied to intravesical administration protocols

These listings determine whether alternative supply chains can enter via generics or authorized equivalents.

Which companies supply Valchlor for intravesical use in the US commercial market?

Valchlor’s commercial supply is controlled by the NDA holder’s distribution arrangements and, in many cases, by limited finished-goods distribution partners. The operational suppliers are:

• The NDA labeler (commercial supplier)
• The contract manufacturer and contract packager at FDA-registered sites
• Import-distribution entities only if the finished product is imported under the NDA

What are the common ways Valchlor supply changes?

When supply is constrained, the NDA holder typically rebalances sourcing among:

• FDA-registered drug product facilities
• Packaging sites
• Alternate upstream drug substance manufacturers, if allowed under the NDA

How to identify Valchlor supplier risks for R&D licensing or litigation due diligence?

Supplier risk is usually mapped in three layers:

1. Regulatory linkage: which FDA-registered facilities are tied to the NDA
2. IP linkage: which patents are listed and whether competitors can market equivalents
3. Operational linkage: whether a facility is the sole or one-of-few source for the finished product

For licensing and litigation work, supplier identification also matters for:

• Obviousness-type design-around routes in formulation
• Substantially similar manufacturing processes tied to method patents
• Paragraph IV generic entry credibility (if an applicant targets Valchlor equivalence)

Key takeaways

• Valchlor supply is defined by NDA-controlled manufacturing and packaging networks tied to FDA-registered facilities and the Orange Book NDA applicant.
• Valrubicin API suppliers are identified indirectly through FDA facility registrations, DMF linkage (when present), and inspection records tied to the drug substance.
• Supplier due diligence for Valchlor should start with Orange Book “Applicant” and then map to FDA facility registration and labeling “manufactured for/distributed by” lines to establish the actual drug product and API sites.

FAQs

1) What is the NDA applicant/labeler for Valchlor (valrubicin) in the US?
The Orange Book “Applicant” field and the Valchlor prescribing information applicant/labeler lines identify the commercial supplier organization for the NDA.

2) Are Valchlor manufacturing sites limited to one facility or multiple FDA-registered plants?
Valchlor’s supply chain is typically multi-site within the NDA holder’s permitted manufacturing and packaging network, as evidenced by FDA-registered facilities used for the finished product.

3) How do I find the Valchlor API (valrubicin) supplier in FDA records?
Map the NDA’s drug substance references through FDA facility registration and DMF linkage (when referenced), then cross-check inspection records for valrubicin API manufacturing sites.

4) Do Valchlor formulation or method-of-use patents affect who can supply Valchlor?
Patent listing can constrain market entry by preventing generic or equivalent supply until expiry or via litigation resolution, licensing, or agreed paragraph IV outcomes.

5) What should be checked in a supplier qualification package for Valchlor?
Check that the site is FDA-registered for the relevant product category and that the manufacturing and packaging facilities are the same as those authorized under the NDA’s regulatory submissions.

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book).
2. U.S. Food and Drug Administration. Labeling and prescribing information for Valchlor (valrubicin). (FDA access).