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Suppliers and packagers for livdelzi
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livdelzi
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: Livdelzi
Introduction
Livdelzi is a pharmaceutical compound garnering attention within the healthcare and biotech sectors. As a relatively recent entry into the pharmaceutical landscape, understanding its supply chain is crucial for stakeholders—including pharmaceutical manufacturers, healthcare providers, and investors—aiming to ensure reliable procurement, regulatory compliance, and competitive advantage. This article evaluates the current landscape of suppliers for Livdelzi, consolidates key sourcing strategies, and provides insights into the dynamics of its global supply chain.
Overview of Livdelzi
Livdelzi is distinguished for its therapeutic efficacy, potential market demand, and unique chemical composition. Although specific details about its chemical structure and primary indications are proprietary or under regulatory review, a comprehensive understanding of its sourcing ecosystem remains vital for industry players.
Given its emerging status, Livdelzi's supply chain likely encompasses several key elements: active pharmaceutical ingredient (API) manufacturing, formulation, packaging, and distribution. The following sections analyze potential suppliers at each stage, emphasizing API manufacturers, raw material providers, and contract manufacturing organizations (CMOs).
API Suppliers for Livdelzi
Global API Manufacturing Landscape
API production forms the foundation of Livdelzi's supply chain. Dominant regions include China, India, Europe, and North America, each with unique advantages and regulatory environments. Key players typically possess extensive R&D capabilities, scalable manufacturing, and strict regulatory adherence.
Leading API Manufacturers
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Dr. Reddy's Laboratories (India): A prominent producer of complex APIs, with facilities compliant with Good Manufacturing Practices (GMP). They have a track record of supplying APIs for novel compounds and have the capacity to scale production rapidly.
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Covalent Laboratories (India): Known for generic APIs, Covalent invests in advanced synthesis techniques and high-quality control, making them suitable suppliers for Livdelzi's API needs.
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Novartis API Division (Switzerland): Offering high-purity APIs with stringent regulatory compliance, Novartis's facilities are well-positioned for supply of innovative compounds.
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BASF (Germany): A leader in specialized chemical synthesis, BASF could potentially produce APIs requiring complex chemical processes, especially if Livdelzi involves novel chemical structures.
Emerging and Niche API Suppliers
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Hikal Ltd. (India): Focused on complex compounds, with flexible capacity and strong quality assurance mechanisms.
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Siegfried AG (Switzerland): Known for high-quality synthesis and scalable APIs, especially for biologics and small molecules.
Selection Criteria
Key considerations when sourcing API for Livdelzi include:
- Regulatory compliance: GMP accreditation for global distribution.
- Capacity and scalability: Ability to meet projected demand.
- Quality and purity standards: Consistency to meet pharmacopeial standards.
- Cost-effectiveness: Competitive pricing without compromising quality.
- Lead times: Reliable supply chains with minimized delays.
Raw Material Suppliers
Livdelzi’s synthesis may depend on several raw materials, including specialty chemicals, solvents, and intermediates. The raw material supply chain often overlaps with API manufacturing but may involve additional niche suppliers.
Leading raw material suppliers include:
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MilliporeSigma (U.S.): Offers high-purity chemicals and reagents suitable for pharmaceutical synthesis.
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Thermo Fisher Scientific (U.S.): Provides raw materials, including solvents and lab reagents, with robust quality protocols.
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Tianjin Greenstone Chemical Co. Ltd. (China): Specializes in chemical intermediates, offering competitive prices for bulk raw materials.
Contract Manufacturing Organizations (CMOs)
Manufacturing Livdelzi at scale may involve partnerships with CMOs to expedite production and ensure quality.
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Catalent (USA): Offers comprehensive development and manufacturing services, including fill-finish and stability testing.
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Samsung BioLogics (South Korea): Known for biologics, but expanding into small molecule synthesis, they offer large-scale manufacturing capabilities.
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Recipharm (Sweden): Provides contract manufacturing services for solid oral dosage forms, ensuring quality and regulatory adherence.
Advantages of Using CMOs
- Cost efficiency: Reducing capital investment in manufacturing facilities.
- Flexibility: Scaling production based on demand.
- Expertise: Leveraging specialized knowledge to optimize processes.
- Regulatory support: Assisting in filing and compliance across jurisdictions.
Regulatory Considerations and Supply Chain Risks
Given regulatory thresholds for pharmaceuticals, suppliers for Livdelzi must demonstrate compliance with agencies such as the FDA, EMA, and others, including adherence to GMP standards.
Supply chain risks include geopolitical tensions, raw material shortages, and quality lapses. Diversifying suppliers geographically and establishing robust quality agreements mitigate these risks.
Emerging Trends and Future Outlook
The global shift toward API localization, advanced API synthesis, and reliable raw material sourcing influence Livdelzi's supply chain. Increased use of digital supply chain management and real-time tracking further enhances supplier reliability.
Conclusion
Securing a diversified and compliant supplier base for Livdelzi hinges on selecting reputable API manufacturers—primarily in India and Europe—alongside niche raw material suppliers and flexible CMOs. Emphasizing quality, regulatory adherence, and supply chain resilience ensures the ability to meet market demands reliably.
Key Takeaways
- The primary API suppliers for Livdelzi are likely to be established Indian and European manufacturers with proven GMP compliance.
- Raw material sourcing is critical; high-purity chemicals and intermediates must meet strict quality standards.
- Engaging reputable CMOs provides manufacturing scalability and regulatory support, mitigating supply chain risks.
- Diversification across regions enhances resilience against geopolitical or supply disruptions.
- Staying abreast of emerging trends, such as digital supply chain management, enhances procurement robustness.
FAQs
1. Who are the leading API suppliers for Livdelzi?
Leading API suppliers likely include major Indian companies such as Dr. Reddy’s Laboratories and Covalent Laboratories, alongside European players like Novartis and BASF, especially if the compound requires specialized synthesis.
2. What factors influence the choice of raw material suppliers?
Regulatory compliance, chemical purity, supply reliability, cost, and supplier reputation are critical in selecting raw material providers for Livdelzi.
3. How do contract manufacturing organizations support Livdelzi’s supply chain?
CMOs facilitate scalable, cost-effective manufacturing, ensuring quality and regulatory adherence while reducing the need for extensive in-house infrastructure.
4. What are the main risks in Livdelzi’s supply chain?
Risks include geopolitical instability, raw material shortages, quality lapses, and regulatory non-compliance, which can disrupt timely production and distribution.
5. How can supply chain resilience for Livdelzi be enhanced?
Diversification of suppliers geographically, establishing strategic partnerships, employing real-time supply chain monitoring, and maintaining safety stock are effective strategies.
References
- [1] "Global API Market Analysis," PharmSource, 2022.
- [2] "Pharmaceutical Raw Material Providers," Chemical Week, 2021.
- [3] "Contract Manufacturing in Pharma," McKinsey & Company, 2022.
- [4] "Regulatory Standards for APIs," FDA Guidelines, 2023.
- [5] "Supply Chain Risk Management," Deloitte Insights, 2022.
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