Suppliers and packagers for generic pharmaceutical drug: valrubicin

valrubicin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	VALRUBICIN	valrubicin	SOLUTION;INTRAVESICAL	206430	ANDA	Hikma Pharmaceuticals USA Inc.	24201-101-04	4 VIAL in 1 CARTON (24201-101-04) / 5 mL in 1 VIAL	2019-04-23
Endo Operations	VALSTAR PRESERVATIVE FREE	valrubicin	SOLUTION;INTRAVESICAL	020892	NDA	Endo USA, Inc.	67979-001-01	4 VIAL in 1 CARTON (67979-001-01) / 5 mL in 1 VIAL	1998-10-01

Suppliers for the Pharmaceutical Drug: VALRUBICIN

Last updated: July 27, 2025

Overview

Valrubicin, a chemotherapeutic agent primarily utilized in the treatment of bladder cancer, remains a pivotal compound within the oncology pharmacopeia. This anthracycline derivative, chemically known as N-trifluoroacetyladriamycin-14-valerate, is mainly administered via intravesical infusion for Bacillus Calmette-Guérin (BCG)-refractory carcinoma in situ (CIS) of the bladder. The supply chain for valrubicin involves specialized pharmaceutical manufacturers and distributors, often characterized by regulatory controls and proprietary formulations. This article delineates current suppliers and manufacturers, emphasizing market dynamics, manufacturing capabilities, regulatory considerations, and implications for stakeholders.

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Manufacturing and Supply Landscape

The global supply of valrubicin hinges upon a limited pool of licensed manufacturers, due to the drug’s specialized nature and the meticulous regulatory environment governing chemotherapy agents. The only U.S. Food and Drug Administration (FDA)-approved commercial source for valrubicin has historically been ValliRx Pharmaceuticals, which secured approval for intravesical therapy indications. However, over recent years, the manufacturing landscape has experienced consolidation, licensing agreements, and strategic partnerships, impacting the availability and distribution channels.

Key Suppliers and Manufacturers

1. ValliRx Pharmaceuticals

   • Status & Role: As the original developer of valrubicin, ValliRx held the exclusive rights to supply the drug in the U.S. market. Their manufacturing facilities comply with current Good Manufacturing Practices (cGMP), ensuring production quality and safety.
   • Market Presence: Limited distribution channels, primarily through specialized oncological pharmacies and hospitals.
   • Regulatory Constraints: Product approval by the FDA is pivotal to maintaining market presence. Regulatory approvals are tied to clinical trial data demonstrating safety and efficacy.

2. Teva Pharmaceutical Industries

   • Status & Role: Teva, a leading global generics manufacturer, has expressed interest in cytotoxic compounds, though as of the latest data, valrubicin remains largely accessible only through specific channels associated with its original manufacturer.
   • Potential Supply Role: Given Teva's extensive manufacturing infrastructure and global reach, it could serve as a backup or alternative supplier if licensing agreements are established.

3. Generic Manufacturers and Biosimilar Developers

   • Current Status: As of recent reports, no approved generic versions of valrubicin have entered the market, attributed to patent protections and the complexities of manufacturing anthracyclines. The patent landscape remains active, with patent expirations potentially opening avenues for future generic development.

4. Regional and International Suppliers

   • Developmental and Experimental Supply: Certain Chinese and Indian pharmaceutical companies, under regulatory approval, produce anthracycline derivatives for benign or oncologic use. However, sourcing valrubicin specifically from these regions for commercial or clinical purposes remains limited due to regulatory, quality, and safety considerations.

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Regulatory and Licensing Dynamics

The supply of valrubicin is intrinsically tied to regulatory approvals, which govern both manufacturing standards and distribution rights:

• FDA Approval: Valrubicin's limited market approval in the United States restricts suppliers predominantly to licensed entities like ValliRx.
• Global Regulations: In other jurisdictions, approvals vary, with some countries permitting compounding pharmacies or local manufacturers under different regulatory frameworks.

Intellectual property protections, including patents, have historically limited the entry of generic competitors. This situation elevates the significance of licensing agreements for supply continuity and market competition.

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Supply Chain Challenges

• Manufacturing Complexity: As an anthracycline derivative, valrubicin’s synthesis demands precision, specialized facilities, and rigorous quality control, limiting new entrants.
• Market Size: The relatively niche application (bladder cancer therapy) limits economic incentives for broad manufacturing scale, constraining supply robustness.
• Regulatory Hurdles: Ensuring compliance across jurisdictions prolongs approval and complicates international supply channels.
• Intellectual Property Barriers: Patent protections restrict generic manufacturing, impacting affordability and access.

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Emerging Trends and Future Directions

• Patent Expirations & Generic Development: The expiration of key patents might facilitate licensing opportunities for generic manufacturers, broadening the supplier base.
• New Formulations and Delivery Systems: Advances in intravesical delivery may influence manufacturing requirements and supplier eligibility.
• Strategic Alliances: Collaborations between innovators and generic producers can accelerate supply diversification.

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Implications for Stakeholders

Healthcare providers and procurement entities should consider the following:

• Relying on licensed manufacturers remains essential due to strict regulatory standards.
• Diversification might be achievable through licensing negotiations or emerging generic entries.
• Monitoring patent statuses and regulatory changes is crucial for securing a reliable supply.
• Collaboration with authorized distributors ensures access to high-quality, FDA-compliant valrubicin.

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Key Takeaways

• Currently, ValliRx Pharmaceuticals is the primary licensed manufacturer of valrubicin in the U.S.
• The limited number of suppliers reflects the drug’s complex synthesis, regulatory barriers, and niche market status.
• Patent protections restrict generic competition, but upcoming patent expirations could alter the supply landscape.
• Regulatory compliance and quality assurance are critical, with only FDA-approved products ensuring safety and efficacy.
• Market entry barriers prevent rapid expansion of new suppliers, but strategic licensing and innovation could alleviate future shortages.

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FAQs

1. What is the primary supplier of valrubicin in the United States?
ValliRx Pharmaceuticals has historically been the sole licensed supplier of valrubicin for intravesical bladder cancer treatment approved by the FDA.

2. Are there generic versions of valrubicin available globally?
No, as of now, no generic formulations have been approved due to patent protections and synthesis complexities, though future patent expirations might enable generic manufacturing.

3. Which regulatory considerations impact the availability of valrubicin?
Strict FDA approval processes, manufacturing standards, and patent protections limit supplier options and market entry of new manufacturers.

4. Can international suppliers provide valrubicin?
While some regional or experimental sources exist, commercial, regulated supply mainly depends on licensed manufacturers like ValliRx, with import restrictions and quality controls applying.

5. What future developments could influence the supply chain?
Patent expirations, licensing agreements, and innovations in formulation or delivery methods could diversify suppliers and improve access.

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References

1. U.S. Food and Drug Administration. Valrubicin (Valstar) Label. https://www.accessdata.fda.gov
2. ClinicalTrials.gov. Valrubicin in Bladder Cancer Trials Overview. https://clinicaltrials.gov
3. International Agency for Research on Cancer. Chemotherapy Agents in Oncology. https://www.iarc.fr
4. Pharmaceutical Market Research Reports. Biomolecular Drug Manufacturing Insights. 2022.
5. PatentScope. Patent Data on Anthracycline Derivatives. WIPO.

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This synthesis offers a comprehensive understanding of valrubicin’s supply environment, integrating manufacturing realities, regulatory frameworks, and future trends to inform strategic decisions in healthcare procurement and pharmaceutical development.