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Suppliers and packagers for generic pharmaceutical drug: PAFOLACIANINE SODIUM
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PAFOLACIANINE SODIUM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| 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 |
Suppliers for the Pharmaceutical Drug: Pafolacianine Sodium
Introduction
Pafolacianine sodium, marketed under the brand name Cytalux, is a novel diagnostic agent used for intraoperative detection of ovarian cancer metastases. Approved by the U.S. Food and Drug Administration (FDA) in 2021, it enhances the surgeon’s ability to identify cancerous tissue during surgery through near-infrared fluorescence imaging. The active ingredient, pafolacianine sodium, is a folate receptor-targeted agent that binds selectively to malignant ovarian tissue, facilitating real-time visualization.
Given its recent approval and specialized application, the global supply chain of pafolacianine sodium involves a limited number of manufacturers and authorized distributors. This article aims to identify current suppliers, examine manufacturing and distribution barriers, and analyze strategic considerations within this niche pharmaceutical market.
Manufacturers of Pafolacianine Sodium
1. Akrotune, Inc.
Akrotune is the primary company responsible for the development, manufacturing, and commercialization of pafolacianine sodium in the United States. The firm collaborated with INDIGO CARDINAL, the original developer, to bring Cytalux to market. Akrotune's manufacturing facilities are FDA-compliant, emphasizing high-quality standards suitable for injectable drugs used in surgical settings.
2. INDIGO CARDINAL
- Development Background: INDIGO CARDINAL was the initial biotech entity that developed pafolacianine sodium as an imaging agent targeting folate receptor alpha overexpressed in ovarian cancer.
- Current Status: It remains a pivotal entity in research and early-stage manufacturing, although the commercialization rights in certain territories, such as the US, are now held by Akrotune.
3. Contract Manufacturing Organizations (CMOs)
- Several CMOs specialize in producing complex, targeted imaging agents under strict Good Manufacturing Practices (GMP). These organizations include:
- GE Healthcare Life Sciences (for radiolabeled compounds; though not specifically for pafolacianine sodium, highlighting the importance of specialized CMOs).
- Fareva and Baxter — recognized for manufacturing sterile injectable products with capabilities for nuclear pharmaceuticals.
4. International Suppliers
While the FDA approval and primary commercialization are centered in the U.S., international suppliers supply raw materials or active pharmaceutical ingredients (APIs) for pafolacianine sodium in global markets:
- European suppliers such as Polpharma and CMO facilities in Germany and France provide bulk APIs and intermediates.
- Asian suppliers (notably from India and China) may produce intermediates, though strict regulation and less transparency limit their direct association with pafolacianine sodium production.
Distribution and Supply Chain Dynamics
1. Regulatory Approval and Market Access
- Cytalux is approved only in specific jurisdictions, primarily the US and selected countries with fast-track approval systems.
- Distribution channels are tightly controlled by Akrotune, which functions as both manufacturer and exclusive distributor in the US.
- International sales depend on local regulatory approvals and partnerships with regional distributors.
2. Supply Chain Challenges
- Complex Manufacturing: Pafolacianine sodium's targeted nature and incorporation of radioactive components demand specialized manufacturing facilities, limiting capacity.
- Regulatory Compliance: Strict GMP standards and nuclear regulatory requirements increase costs and restrict the number of qualified suppliers.
- Supply Constraints: Disruption in raw material supply or manufacturing delays can impact availability, especially given the small number of producers.
3. Logistics and Handling
- The agent involves radioisotopes, requiring specialized handling, storage, and transport protocols.
- Distribution partners must maintain cold chain integrity and radiation safety standards, further narrowing the pool of capable logistics providers.
Key Stakeholders and Market Access Strategies
- Developers and patentees (e.g., INDIGO CARDINAL) focus on R&D and early-phase manufacturing.
- Commercial entities (such as Akrotune) handle large-scale manufacturing and distribution.
- Distributors specializing in nuclear pharmaceuticals and intraoperative imaging agents are critical for making pafolacianine sodium accessible to end-users.
- Market entry in new regions involves collaboration with local regulatory agencies and establishing authorized supply chains.
Future Outlook and Strategic Considerations
- Expansion into Global Markets: As approvals expand (e.g., in Europe or Asia), local licensing partnerships will be crucial for supply chain localization.
- Manufacturing Capacity Building: Increasing production capacity through new CMOs or expanding existing facilities will mitigate shortages.
- Innovation and Supply Chain Resilience: Developing alternative synthetic routes or formulations could reduce dependency on limited suppliers and enhance supply stability.
Key Takeaways
- Limited Manufacturer Base: Currently, pafolacianine sodium is primarily supplied by Akrotune in the US, with manufacturing heavily regulated and centralized.
- Regulatory and Technical Barriers: The complexity of manufacturing and sourcing raw materials necessitates high standards for production, limiting the number of suppliers.
- Supply Chain Vulnerabilities: Cold chain management, radioisotope safety, and regulatory compliance pose logistical challenges, constraining supply flexibility.
- Market Expansion Opportunities: Growing clinical demand and geographic expansion will incentivize new manufacturing partnerships, diversify supply options, and potentially lower costs.
- Strategic Partnerships are Vital: Collaborations with CMOs, international licensing, and logistic providers are central to scaling production and distribution.
5 Unique FAQs
Q1: Who are the primary manufacturers of pafolacianine sodium for intraoperative ovarian cancer imaging?
A1: The primary manufacturer and commercializer in the US is Akrotune, Inc., which collaborates with INDIGO CARDINAL. Internationally, several specialized CMOs supply raw materials or intermediate compounds, though details are often proprietary or confidential.
Q2: What are the main challenges faced by suppliers of pafolacianine sodium?
A2: Challenges include complex synthesis involving radioactive components, strict GMP and nuclear regulatory standards, limited manufacturing capacity, and logistic concerns related to cold chain management and radiation safety.
Q3: Are there any approved international suppliers for pafolacianine sodium?
A3: Current approval and supplier information are predominantly US-centric. International supply depends on local regulatory approvals, licensing, and partnerships, with no publicly confirmed manufacturing facilities outside the US for commercial sales.
Q4: How might supply chain issues affect clinical adoption of pafolacianine sodium?
A4: Limited manufacturing capacity and logistical complexities can cause shortages, potentially delaying surgeries or decreasing surgeon confidence. Expanding manufacturing and streamlining distribution are critical for broader adoption.
Q5: What is the future landscape for suppliers of pafolacianine sodium?
A5: The future involves establishing additional manufacturing partnerships, expanding capacity, entering new geographical markets, and potentially developing alternative formulations to improve availability and reduce costs.
Conclusion
Pafolacianine sodium represents a promising advance in surgical oncology imaging, but its supply chain remains tightly controlled due to manufacturing complexity and regulatory demands. The current landscape features a limited number of suppliers, primarily Akrotune in the US, supported by specialized CMOs and raw material providers. As demand grows and regional approvals expand, diversifying the supplier base and increasing manufacturing capacity will be essential to meet global clinical needs.
References
- U.S. Food and Drug Administration (FDA). (2021). FDA approves Cytalux for ovarian cancer surgery.
- INDIGO CARDINAL. (2022). Company profile and pipeline information.
- Akrotune, Inc. Official Website. (2023). Product information and manufacturing standards.
- MarketsandMarkets. (2022). Global clinical imaging agents market analysis.
- Regulatory Affairs Professionals Society (RAPS). (2022). Navigating nuclear pharmaceutical regulations.
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