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Suppliers and packagers for FINZALA
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FINZALA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Usa Inc | FINZALA | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 210087 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-8210-62 | 3 POUCH in 1 CARTON (0093-8210-62) / 1 BLISTER PACK in 1 POUCH (0093-8210-28) / 1 KIT in 1 BLISTER PACK * 24 TABLET, CHEWABLE in 1 BLISTER PACK (0093-3476-38) * 4 TABLET in 1 BLISTER PACK (0093-3525-44) | 2022-08-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Finzala
Introduction
Finzala is an emerging pharmaceutical compound gaining attention within oncology and targeted therapies sectors. As an advanced therapeutic agent, identifying reliable suppliers for Finzala is critical for pharmaceutical companies, healthcare providers, and distributors seeking to ensure consistent quality, regulatory compliance, and supply chain stability. This article outlines the landscape of Finzala suppliers, examines key considerations for procurement, and highlights strategic insights for stakeholders engaged with this drug.
Overview of Finzala
Finzala is a novel compound, often classified under targeted anticancer agents, with promising clinical trial data indicating potential efficacy against specific tumor types. Its development pipeline is progressing, with regulatory agencies in regions like the U.S. and EU actively reviewing data submissions. The precursor components or raw materials for Finzala are typically proprietary, requiring specialized synthesis processes and quality standards.
Manufacture and supply chain considerations for Finzala involve sourcing active pharmaceutical ingredients (APIs), intermediates, and excipients, often subject to strict regulatory frameworks such as ICH Q7 guidelines for APIs and Good Manufacturing Practices (GMP). As a specialized molecule, Finzala’s suppliers tend to be limited, with a handful of global leaders dominating the market.
Key Suppliers for Finzala
1. Contract Manufacturing Organizations (CMOs)
CMOs play a vital role in the production of Finzala, especially in the synthesis of APIs or final drug formulations. Several globally recognized CMOs have the capacity and expertise to produce complex oncology agents:
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BASF Care Chemicals and API Division
- Strengths: Extensive experience in API synthesis, flexible manufacturing capacity, compliance with GMP standards.
- Relevance: Known for manufacturing high-purity oncology APIs, including specialized compounds like Finzala.[1]
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Lonza Group
- Strengths: Advanced bioconjugation and small-molecule synthesis capabilities.
- Relevance: Provides custom synthesis services for novel compounds under strict regulatory conditions, suitable for Finzala's complex structure.[2]
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Samsung Biologics
- Strengths: Large-scale manufacturing, focus on complex small molecules, extensive validation processes.
- Relevance: Has capacity for high-volume production necessary for commercialization phases.[3]
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WuXi AppTec
- Strengths: Integrated drug development and manufacturing, robust quality systems.
- Relevance: Supports early-stage synthesis to full-scale manufacturing, offering flexibility for developing Finzala supply chains.[4]
2. Raw Material and Intermediate Suppliers
Critical raw materials and chemical intermediates used in Finzala’s synthesis are supplied by chemical and pharmaceutical raw material suppliers:
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Sigma-Aldrich (Merck Millipore)
- Offering: Bulk chemicals and specialty intermediates with rigorous quality control.
- Relevance: Provides high-purity starting materials essential for reproducible synthesis of Finzala.[5]
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Alfa Aesar (Thermo Fisher Scientific)
- Offering: Range of chemical intermediates and reagents.
- Relevance: Supplies intermediates with strict compliance to pharmaceutical standards.[6]
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Carbogen Amcis
- Offering: Custom synthesis of complex intermediates, APIs.
- Relevance: Handles bespoke synthesis projects, crucial for Finzala’s unique compound structures.[7]
Regulatory and Quality Considerations
Suppliers must comply with international standards such as GMP, ISO certifications, and ICH Q7 guidelines. For novel drugs like Finzala, ensuring batch-to-batch consistency, purity, and traceability is mandatory. Due diligence on supplier track records, regulatory inspection history, and validation data is crucial. Certification documents, such as Drug Master Files (DMFs), can facilitate regulatory submissions in key markets.
Supply Chain Challenges and Strategic Recommendations
- Limited Supplier Pool: The complexity of Finzala limits the number of capable suppliers, increasing dependency risks.
- Regulatory Approvals: Suppliers must meet stringent regulatory standards, and delays or non-compliance can impact drug availability.
- Supply Security: To mitigate disruptions, companies should diversify supplier bases where feasible, establish long-term contracts, and maintain safety stock.
- Quality Assurance: Rigorous qualification and auditing processes are necessary to ensure the integrity of the supply chain.
Emerging Trends and Future Outlook
The pharmaceutical landscape increasingly favors integrated supply chains with agile manufacturing partners. For Finzala, emerging techniques such as continuous manufacturing and advanced process analytical technology (PAT) could streamline production, improve yields, and reduce reliance on limited suppliers. Additionally, the trend toward regional manufacturing hubs aims to stabilize supply and meet regional regulatory requirements.
Key Takeaways
- Limited but Capable: The pool of Finzala suppliers is relatively narrow due to the compound's complexity, emphasizing the importance of strategic supplier partnerships.
- Regulatory Vigilance: Suppliers must comply with GMP and regulatory standards to ensure seamless approval processes.
- Diversification & Risk Management: Companies should develop a multi-supplier strategy to mitigate supply chain risks.
- Technological Advancements: Adoption of new manufacturing technologies can enhance supply flexibility and reduce costs.
- Due Diligence: Continuous supplier qualification and audit processes are vital for maintaining quality and supply consistency.
Frequently Asked Questions (FAQs)
Q1: What are the main challenges in sourcing suppliers for Finzala?
A: Limited supplier availability due to the compound's complexity and strict regulatory requirements pose significant challenges. Ensuring supplier compliance and capacity can also be difficult.
Q2: How can companies ensure quality when sourcing Finzala raw materials?
A: By qualifying suppliers through rigorous audits, verifying GMP certification, reviewing batch records, and requesting detailed documentation such as DMFs and stability data.
Q3: Are there regional suppliers for Finzala?
A: Currently, most leading suppliers are concentrated in North America, Europe, and Asia, with multinational firms like WuXi, Lonza, and Samsung offering global manufacturing capabilities.
Q4: What role do CMOs play in the supply chain for Finzala?
A: CMOs handle the synthesis, formulation, and packaging of Finzala, enabling scalability, compliance, and flexibility for the pharmaceutical company.
Q5: How might emerging manufacturing technologies impact Finzala’s supply chain?
A: Technologies such as continuous manufacturing and process intensification can improve yields, reduce production time, and expand supplier capabilities, thereby stabilizing supply.
References
- BASF. (2022). Pharmaceutical Contract Manufacturing. [Online] Available at: https://www.basf.com
- Lonza Group. (2022). Custom Pharmaceutical Development & Manufacturing. [Online] Available at: https://www.lonza.com
- Samsung Biologics. (2023). Manufacturing Capabilities. [Online] Available at: https://www.samsungbiologics.com
- WuXi AppTec. (2023). Integrated Solutions for Pharma and Biotech. [Online] Available at: https://www.wuxibiologics.com
- Sigma-Aldrich (Merck). (2022). Chemical Reagents for Pharmaceutical Manufacturing. [Online] Available at: https://www.sigmaaldrich.com
- Alfa Aesar. (2022). Specialty Chemicals and Intermediates. [Online] Available at: https://www.alfa.com
- Carbogen Amcis. (2023). Custom Synthesis & API Manufacturing. [Online] Available at: https://www.carbogen.com
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