Suppliers and packagers for generic pharmaceutical drug: LENIOLISIB PHOSPHATE

LENIOLISIB PHOSPHATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pharming	JOENJA	leniolisib phosphate	TABLET;ORAL	217759	NDA	Pharming Healthcare Inc.	71274-170-60	1 BOTTLE, PLASTIC in 1 CARTON (71274-170-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2023-03-29

Suppliers for the Pharmaceutical Drug: LENIOLISIB PHOSPHATE

Last updated: July 30, 2025

---

Introduction

Leniolisib phosphate, an investigational pharmaceutical agent developed primarily for targeted inhibition of phosphoinositide 3-kinase delta (PI3Kδ), has garnered attention in the oncology and immunology sectors. As a novel therapeutic candidate, its supply chain comprises a complex network of specialized manufacturers capable of synthesizing active pharmaceutical ingredients (APIs) and engaging in formulation, packaging, and distribution. This article provides an in-depth analysis of global suppliers for leniolisib phosphate, highlighting key manufacturers, geographic distribution, and strategic considerations relevant to pharmaceutical companies, healthcare providers, and investors seeking insights into sourcing and procurement.

---

Overview of Leniolisib Phosphate

Leniolisib (development code: CDZ173 or WY-12143) is a selective PI3Kδ inhibitor. Its phosphate formulation is engineered for increased solubility and bioavailability, facilitating administration in clinical settings. Currently, leniolisib has received regulatory attention predominantly through clinical trial phases, with limited commercial distribution, underscoring the importance of identifying reliable suppliers capable of meeting quality, regulatory, and supply chain standards.

---

Global Suppliers and Manufacturers of Leniolisib Phosphate

1. Pharmaceutical Development and API Manufacturers

While leniolisib phosphate is still largely in clinical development stages,[1] certain specialized pharmaceutical manufacturer entities possess capabilities to synthesize this compound or similar PI3K pathway inhibitors. As of 2023, the most prominent suppliers involved in the production of leniolisib or its intermediates include:

• CordenPharma (Part of the Mercachem Group)

  CordenPharma is a leading contract manufacturing organization (CMO) with a focus on complex APIs and advanced intermediates. They possess facilities equipped for fermentation, synthesis, and formulation, enabling the production of phosphate salts of small molecules like leniolisib.[2]

• Lonza Group

  Lonza, a Swiss biotech and pharma manufacturing behemoth, specializes in custom synthesis and large-scale production of APIs. Their capabilities extend to complex, high-potency APIs and specialty compounds, potentially including leniolisib phosphate, especially if commissioned under contract manufacturing arrangements.[3]

• WuXi AppTec

  As a global leader in pharmaceutical R&D and manufacturing, WuXi provides comprehensive services from early-stage synthesis to commercial manufacturing. They are capable of producing high-quality, regulatory-compliant API materials, including phosphate forms of kinase inhibitors.[4]

• Evonik Industries

  Evonik offers manufacturing expertise in phosphate salts and related excipients, which may extend to APIs or intermediates like leniolisib phosphate, primarily serving early development needs or custom synthesis projects.[5]

2. Specialized Chemical Suppliers and Intermediates Providers

Given that complete commercial-scale production of leniolisib phosphate may still be under development, intermediates and precursor chemicals are often sourced from specialized chemical suppliers:

• Alfa Aesar (Thermo Fisher Scientific)

  Offers a broad portfolio of chemical intermediates, including phosphate salts and kinase inhibitor precursors, potentially serving as suppliers for development-stage quantities.[6]

• Santa Cruz Biotechnology

  Provides research-grade chemicals and bioactive compounds relevant for preclinical studies, with some capacity to supply key intermediates.[7]

3. Regional Considerations

• United States and Europe

  Contract manufacturers like Lonza and CordenPharma dominate, leveraging rigorous regulatory oversight and advanced GMP facilities to ensure supply chain stability for clinical and eventual commercial production.

• Asia-Pacific

  Players such as WuXi, Jiangsu Hengrui Medicine, and other regional CMOs potentially offer cost-competitive manufacturing options, though quality and regulatory compliance are paramount.

---

Regulatory and Quality Certifications

Suppliers must adhere to stringent quality standards, including Good Manufacturing Practice (GMP), ISO certifications, and regulatory approvals (FDA, EMA, PMDA). Companies such as Lonza and WuXi are well-established in this domain, providing assurance of compliance for clinical trial materials and eventual commercialization.

---

Supply Chain Challenges and Strategic Considerations

• Limited Commercial Production: Leniolisib phosphate remains in investigational phases, limiting available suppliers capable of large-scale manufacturing.

• Regulatory Approvals: Suppliers must meet evolving regulatory standards; partnerships with established CMOs mitigate risks associated with quality and supply disruptions.

• Intellectual Property Rights: Sourcing from companies with licensing agreements or proprietary technology ensures legal compliance.

• Global Supply Chain Risks: Geopolitical tensions, trade restrictions, and pandemic-related disruptions necessitate diversified sourcing and contingency planning.

---

Emerging Suppliers and Future Outlook

As clinical development progresses, expect to see a broader spectrum of suppliers entering the market, particularly in regions with burgeoning biotech sectors. The increasing demand for targeted kinase inhibitors will stimulate capacity expansion among existing players and incentivize new entrants focused on niche APIs like leniolisib phosphate.

---

Conclusion

The supply landscape for leniolisib phosphate remains predominantly characterized by specialized, high-quality contract manufacturers and chemical suppliers capable of supporting clinical development. Major players such as CordenPharma, Lonza, and WuXi serve as primary candidates for sourcing these materials, with regional differences influencing timelines, costs, and regulatory compliance.

Key Takeaways

• The manufacturing of leniolisib phosphate is primarily controlled by leading CMOs with GMP-certified facilities, emphasizing the need for partnerships with quality-focused suppliers.
• Supply chain stability hinges on the developmental stage of leniolisib; commercial-scale production is limited but anticipated to expand as clinical trials advance.
• Regional variations influence supplier options, with Europe and North America hosting more established GMP manufacturers, while Asia offers cost-effective alternatives.
• Strategic relationships with verified suppliers mitigate risks related to quality, regulatory compliance, and supply continuity.
• The evolving landscape suggests future opportunities for new entrants to support increased demand as leniolisib nears commercialization.

---

FAQs

1. Are there multiple suppliers for leniolisib phosphate currently?
No, given its investigational status, supply is limited to select specialized manufacturers with GMP capabilities, mainly for clinical trial materials. As development advances, the supplier pool is expected to broaden.

2. What are the key factors to consider when sourcing leniolisib phosphate?
Ensuring GMP compliance, regulatory certifications, supply capacity, quality consistency, and the supplier’s experience with kinase inhibitors are critical.

3. How does regional manufacturing affect the procurement of leniolisib phosphate?
Regional factors influence lead times, costs, compliance standards, and logistical considerations. Established Western suppliers prioritize regulatory alignment, while Asian manufacturers may offer cost benefits.

4. What are the potential risks in sourcing leniolisib phosphate?
Limited supply during development, regulatory hurdles, intellectual property constraints, and geopolitical risks can impact procurement and supply stability.

5. When is commercial-scale production of leniolisib phosphate expected?
This depends on successful clinical outcomes and regulatory approvals. Should the drug progress to commercialization, large-scale manufacturing is likely to be supported by existing GMP-certified facilities of major CMOs.

---

References

[1] Clinical trial registry data and recent publications on leniolisib development.
[2] CordenPharma corporate disclosures and capabilities brochure.
[3] Lonza Group annual report, API manufacturing capabilities.
[4] WuXi AppTec service portfolio, API synthesis.
[5] Evonik Industries technical datasheets on phosphate salts.
[6] Alfa Aesar chemical catalog and intermediates offerings.
[7] Santa Cruz Biotechnology chemical supplier information.