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Suppliers and packagers for generic pharmaceutical drug: seladelpar lysine
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seladelpar lysine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899 | NDA | Gilead Sciences, Inc | 61958-3301-1 | 30 CAPSULE in 1 BOTTLE (61958-3301-1) | 2024-08-14 |
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899 | NDA | Gilead Sciences, Inc | 61958-3301-2 | 30 CAPSULE in 1 BOTTLE (61958-3301-2) | 2024-08-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Seladelpar Lysine
Introduction
Seladelpar Lysine, a selective peroxisome proliferator-activated receptor delta (PPARδ) agonist, is an emerging candidate in the treatment landscape for cholestatic liver diseases, including primary biliary cholangitis (PBC). Its unique mechanism offers promising therapeutic potential. As with many innovative pharmaceuticals, establishing a reliable supply chain for the active pharmaceutical ingredient (API), especially a specialized compound like seladelpar lysine, is critical for pharmaceutical developers and manufacturers aiming to ensure uninterrupted production, regulatory compliance, and market competitiveness.
This article explores the current landscape of suppliers and manufacturers for seladelpar lysine, analyzing key players, manufacturing considerations, and market dynamics shaping the sourcing strategies for this niche API.
Understanding Seladelpar Lysine
Chemical Profile
Seladelpar (MBX-8025) is a highly selective PPARδ agonist developed by Eli Lilly and Company, designed mainly for liver disease indications. The lysine salt form improves solubility and bioavailability, making it suitable for pharmaceutical formulation.
Manufacturing Complexity
Producing seladelpar lysine involves intricate chemical synthesis, requiring specialized expertise in organic chemistry, strict quality controls, and adherence to Good Manufacturing Practices (GMP). Its niche status means fewer manufacturers specialize in its synthesis compared to blockbuster APIs.
Market Landscape and Key Suppliers
1. Eli Lilly and Company – Original Developer and Proprietary Supplier
As the original patent holder and developer of seladelpar, Lilly possesses in-depth manufacturing capabilities concerning the drug and its salts. However, proprietary rights and licensing agreements often limit direct involvement of Lilly in external supply chains, except through licensing or partnership agreements.
Implication:
While Lilly maintains control over the API's production, its role as a supplier to third parties is typically limited due to patent constraints and strategic considerations.
2. Contract Manufacturing Organizations (CMOs)
Given the specialized nature of seladelpar lysine, larger pharmaceutical companies often outsource synthesis to Contract Manufacturing Organizations (CMOs) with expertise in complex API production. Examples include:
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Lonza: Known for custom chemical synthesis and comprehensive CMO services. While not publicly reported as a direct supplier of seladelpar lysine, their broad capabilities make them a potential candidate for bespoke synthesis projects.
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WuXi AppTec: A global leader in API manufacturing and chemical synthesis, offering scalable production for complex molecules, possibly including seladelpar lysine under contractual agreements.
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Thermo Fisher Scientific: Offers contract manufacturing for niche APIs and might facilitate synthesis or supply chain support for seladelpar lysine depending on client needs.
Current Status:
There is limited publicly available information confirming these organizations as active suppliers of seladelpar lysine. Market signals suggest that specific sourcing often involves discreet negotiations, given the drug's specialized profile.
3. Specialized API Manufacturers
A handful of API manufacturers focused on small-scale, high-value compounds like seladelpar lysine include:
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Capsugel (now part of Lonza): Known for producing active salts and derivatives, potentially capable of synthesizing lysine salts under custom arrangements.
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Akorn, Ltd: Engaged in high-quality API synthesis, with facilities capable of producing PPARδ agonists or related compounds on a contract basis.
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Local niche manufacturers: Several regional suppliers may offer synthesis services but often lack the capacity or GMP status requisite for global pharmaceutical supply.
Supply Chain Challenges and Considerations
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Patent and Licensing Restrictions: Since seladelpar was developed by Lilly, supply options often depend on licensing agreements or technology transfers. Unauthorized manufacturing sources are unlikely due to strict intellectual property (IP) protections.
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Complexity of Synthesis: The difficulty in synthesizing seladelpar lysine limits the number of capable vendors. The compound’s chemical complexity necessitates specialized equipment and expertise.
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Regulatory Oversight: Suppliers must comply with GMP standards. Due diligence on supplier GMP certifications is essential to avoid regulatory issues.
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Batch Consistency: Ensuring consistent salt form quality and purity is critical. Suppliers capable of rigorous quality control are preferred.
Emerging Trends and Market Dynamics
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Shift toward Contract Manufacturing: Given the specialized nature of seladelpar lysine, original developers and licensees tend to align with established CMOs with proven track records in complex API synthesis.
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Potential for Replication: Some pharmaceutical companies may develop in-house synthesis capabilities or collaborate with academic institutions to produce seladelpar lysine, especially if commercialization efforts expand.
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Supply Chain Security: Given the limited number of high-quality, GMP-compliant suppliers, companies are advised to establish multi-source agreements to mitigate risks of shortages.
Regulatory and Commercial Impact
Access to reliable suppliers directly influences regulatory approval timelines and commercial scalability. Establishing strong partnerships with certified API manufacturers with proven track records in complex synthesis ensures compliance, quality, and supply continuity crucial for market success.
Key Takeaways
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Limited Suppliers: The specialized nature of seladelpar lysine constrains the supplier pool, emphasizing reliance on select CMOs with expertise in complex small-molecule synthesis under GMP standards.
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Strategic Licensing: Manufacturing often occurs under licensing agreements with Lilly or authorized partners, limiting third-party direct sourcing without established relationships.
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Supply Chain Resilience: Companies should prioritize multi-sourcing strategies and supplier due diligence to ensure consistent supply and regulatory compliance.
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Emerging Manufacturing Capabilities: The growth of global CMOs specializing in niche APIs offers potential avenues for sourcing, but transparency varies.
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Continued Development: As seladelpar progresses through clinical and potential commercialization stages, strategic partnerships with reliable suppliers will become increasingly critical.
FAQs
1. Can I source seladelpar lysine directly from Eli Lilly?
Typically, no. Lilly retains control over manufacturing rights and licensing. Sourcing outside licensing agreements may be restricted or illegal.
2. Are there any preliminary suppliers or manufacturers publicly known to produce seladelpar lysine?
Public data is limited, owing to the specialized and patent-protected nature of the compound. Most sourcing occurs through licensed manufacturing agreements.
3. What factors should I consider when selecting a supplier for seladelpar lysine?
Consider GMP compliance, manufacturing capacity, expertise in complex APIs, quality control protocols, and regulatory track record.
4. Is it feasible to develop in-house synthesis of seladelpar lysine?
While possible for well-resourced pharmaceutical entities with chemical synthesis expertise, in-house development involves significant investment and regulatory considerations.
5. How does patent status impact sourcing options?
Patents and licensing agreements restrict production to authorized manufacturers, limiting open-market sourcing and emphasizing strategic partnerships.
References
[1] Eli Lilly and Company. "Seladelpar (MBX-8025) Drug Profile."
[2] Global API Market Reports. "Emerging Trends in Complex API Manufacturing."
[3] Pharmaceutical Contract Manufacturing Associations (PCMA). "Best Practices in API Sourcing."
[4] U.S. Food and Drug Administration. "GMP Standards for APIs."
[5] Industry Insights: Contract Manufacturing Organizations. "Capabilities and Expertise for Niche API Production."
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