Suppliers and packagers for TREANDA

TREANDA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;INTRAVENOUS	022249	NDA	Cephalon, LLC	63459-390-08	1 VIAL, SINGLE-DOSE in 1 CARTON (63459-390-08) / 5 mL in 1 VIAL, SINGLE-DOSE	2010-01-05
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;INTRAVENOUS	022249	NDA	Cephalon, LLC	63459-391-20	1 VIAL, SINGLE-DOSE in 1 CARTON (63459-391-20) / 20 mL in 1 VIAL, SINGLE-DOSE	2008-03-31
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	022249	NDA	Cephalon, LLC	63459-390-08	1 VIAL, SINGLE-DOSE in 1 CARTON (63459-390-08) / 5 mL in 1 VIAL, SINGLE-DOSE	2010-01-05

Suppliers and packagers for TREANDA

Last updated: May 26, 2026

TREANDA (bendamustine) suppliers: contract manufacturers, API makers, and key upstream vendors

Executive summary: TREANDA (bendamustine hydrochloride) is a branded oncology product (alkylating agent). Commercial supply chains for bendamustine-based products typically rely on specialized sterile fill-finish and hazardous drug handling capacity plus downstream vial/packaging operations and upstream bendamustine API manufacture. However, a complete, source-backed map of the exact TREANDA-labeled manufacturing sites and the current named API/finished-dose suppliers cannot be produced from the information available here.

Who supplies TREANDA (bendamustine) drug product and packaging?

Featured answer: TREANDA’s finished-dose supply is produced in licensed pharmaceutical manufacturing sites using hazardous drug controls appropriate for cytotoxics, followed by vial filling, stopper application, lyophilization only if applicable to the specific presentation, labeling, and distribution under FDA-regulated quality systems.

What parts of the TREANDA supply chain require dedicated suppliers?

• Drug product manufacturing: batch synthesis-to-formulation under cGMP, with containment and waste handling for cytotoxic compounds.
• Sterile or non-sterile processing: the specific processing mode depends on the product presentation (powder vs ready-to-dilute liquid, and whether sterile filtration/fill is used).
• Fill-finish: vial filling, inspection, sealing, and packaging for sterile oncology workflows.
• Secondary packaging and distribution: cartons, labeling in compliance with FDA requirements, cold chain if any, and logistics.

Common supplier archetypes for TREANDA-like oncology products

• Cytotoxic contract manufacturing organizations (CMOs) with oncology HPAPI lines
• Fill-finish partners specializing in oncology vials
• Labeling/serialization and distribution logistics providers

Who makes bendamustine hydrochloride (TREANDA API) for commercial supply?

Featured answer: Bendamustine hydrochloride (the active ingredient in TREANDA) is produced by specialty chemical manufacturers with controlled impurity profiles and scalable purification.

Upstream API supplier capabilities that matter for bendamustine

• Controlled synthesis route and impurity control strategy
• Robust analytics: chiral or isomer control (where applicable), residual solvent and nitrosamine controls, heavy metal limits
• Batch-to-batch consistency with defined specs for oncology use

What typically constrains API supply for TREANDA?

• Limited number of qualified API producers meeting oncology-grade specs
• Hazardous handling and stringent quality documentation for regulatory filings
• Concentration risk when a single API route dominates global supply

What is the Orange Book status of TREANDA and what does it imply for sourcing?

Featured answer: Orange Book listings can identify the approved drug product, dosage forms, and related patent coverage but do not directly name suppliers. Orange Book data can still help infer which versions and presentations are on the market and which manufacturing sites support approvals.

How Orange Book data is used in supplier mapping

• Link between specific dosage forms and approved manufacturing/labeling configurations
• Identification of listed patents that correlate with the innovator’s lifecycle and, indirectly, with which presentations remain actively promoted

How do FDA approvals and manufacturing inspections affect TREANDA suppliers?

Featured answer: FDA inspection outcomes can change the set of qualified manufacturing sites, especially for sterile/HPAPI processes.

FDA information used to validate suppliers

• Establishment registration and manufacturing location history
• Inspection classifications and remediation timelines
• Changes in manufacturing sites reflected in FDA supplements

What contract manufacturing sites commonly handle bendamustine and other cytotoxics?

Featured answer: The practical supplier set for bendamustine products is usually dominated by a small number of CMOs with:

1. HPAPI containment systems
2. validated cleaning and waste handling
3. oncology-grade quality management

Typical site requirements for cytotoxic fill-finish

• High-containment manufacturing suites and validated decontamination
• Cross-contamination risk controls appropriate for potent alkylators
• Documented environmental monitoring and operator protection

Which companies are TREANDA suppliers in the US market?

Featured answer: The supplier landscape depends on whether the question targets:

• API manufacturers (global chemical producers)
• Finished-dose CMOs (US and overseas fill-finish sites)
• Marketing authorization holders and their supply agreements

A defensible list of named companies requires direct linkage to FDA facility disclosures, Orange Book manufacturing information, and current company supply-chain documentation. That specific, source-anchored supplier roster is not available in the material provided here.

What generic entry risks exist for TREANDA that affect supplier demand?

Featured answer: Supplier demand for TREANDA-like drug product manufacturing can shift based on generic or biosimilar entry timelines, patent losses, and FDA approvals.

How supplier economics change with generic competition

• Lower price pressure increases the value of manufacturing efficiency and scale
• CMOs may rebalance capacity toward high-volume generics if brand demand declines
• API sourcing can tighten if downstream demand increases for approved generics

Key information required to produce an accurate TREANDA supplier list

A complete supplier list must be grounded in at least one of the following:

• FDA establishment/manufacturing site disclosures tied to the approved TREANDA product
• Orange Book manufacturing site entries for the specific dosage form
• Public CMC disclosures and labeling package insert manufacturing sections
• Verified inspection and compliance documentation tied to named establishments

No such source-backed supplier mapping content is present in the current input, so a precise supplier answer cannot be generated.

Key Takeaways

• TREANDA is a bendamustine oncology drug that uses a specialized cytotoxic supply chain.
• Supplier mapping for TREANDA requires source-linked identification of API and finished-dose manufacturing sites.
• The necessary source data to name specific API makers, CMOs, and fill-finish vendors is not provided here.

FAQs

1. Who are bendamustine hydrochloride API manufacturers used for US oncology supply chains?
2. Which CMOs specialize in hazardous drug fill-finish for cytotoxic injectables like bendamustine?
3. Does TREANDA’s FDA labeling list manufacturing sites that can identify suppliers?
4. How do patent status changes for bendamustine affect contract manufacturing demand?
5. What FDA inspection signals most often lead to manufacturing site changes for cytotoxic injectables?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-05-26).
2. FDA. Drug Establishment Registration and Listing System (DRLS) and related establishment information. (Accessed 2026-05-26).
3. FDA. cGMP inspection reports and enforcement actions database. (Accessed 2026-05-26).