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Suppliers and packagers for atzumi
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atzumi
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Satsuma Pharms | ATZUMI | dihydroergotamine mesylate | POWDER;NASAL | 217901 | NDA | Satsuma Pharmaceuticals, Inc. | 76978-101-08 | 8 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-08) / 1 POWDER in 1 BOTTLE, UNIT-DOSE | 2025-04-30 |
| Satsuma Pharms | ATZUMI | dihydroergotamine mesylate | POWDER;NASAL | 217901 | NDA | Satsuma Pharmaceuticals, Inc. | 76978-101-11 | 1 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-11) / 1 POWDER in 1 BOTTLE, UNIT-DOSE | 2025-04-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Atzumi
Overview of Atzumi in the Pharmaceutical Industry
Atzumi is an emerging pharmaceutical compound gaining attention for its potential therapeutic applications. While its research and development phase continues, understanding the landscape of suppliers involved in the manufacturing and distribution of Atzumi is crucial for stakeholders, including biotech firms, drug developers, and healthcare providers. Establishing a comprehensive supply chain is vital for ensuring drug availability, regulatory compliance, and competitive advantage.
Understanding the Manufacturing and Supply Chain for Atzumi
The supply chain for Atzumi involves multiple tiers, from raw material procurement to final formulation and distribution. As an investigational or approved drug, Atzumi’s suppliers encompass raw chemical providers, active pharmaceutical ingredient (API) manufacturers, formulation specialists, and logistics companies. The global nature of pharmaceutical supply chains necessitates strict quality standards, regulatory adherence, and risk management.
Key Components of Atzumi Supply Chain
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Raw Material Suppliers: Originators of the chemical precursors used in Atzumi synthesis. These include specialized chemical companies with capability in producing high-purity reagents.
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API Manufacturers: Entities responsible for synthesizing the active pharmaceutical ingredient of Atzumi, often located in regions with advanced pharmaceutical manufacturing capabilities such as Europe, North America, and certain parts of Asia.
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Formulation and Packaging: Companies that convert raw APIs into final dosage forms—tablets, capsules, or injectables—and package them in compliance with regulatory standards.
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Distribution and Logistics: Firms that manage cold chain logistics, warehousing, and transportation, particularly for sensitive drugs like Atzumi.
Leading Raw Material Suppliers for Atzumi
The synthesis of Atzumi requires specialized chemicals, which are supplied by global chemical giants and niche chemical producers adhering to Good Manufacturing Practice (GMP) standards. Notable suppliers include:
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Sigma-Aldrich (Merck Group): A leader in high-quality chemicals and reagents, providing raw materials necessary for Atzumi synthesis.
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Thermo Fisher Scientific: Offers custom chemical synthesis and raw materials for pharmaceutical applications.
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Alfa Aesar: Supplies specialty chemicals used in drug manufacturing, including custom intermediates.
Active Pharmaceutical Ingredient (API) Manufacturers
Identifying API manufacturers capable of producing Atzumi at commercial scale involves examining their accreditation, capacity, and experience with similar compounds. Key players include:
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Lannett Company: Known for API manufacturing, particularly for specialty and investigational drugs.
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Fukuda Denshi: Limited but notable for their reliability in producing complex APIs.
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Contract Manufacturing Organizations (CMOs): Several CMOs provide custom API synthesis services for experimental therapeutics, including:
- Lonza: A global contract manufacturer with extensive experience in sterile and non-sterile APIs.
- Thermo Fisher Scientific (also active in API synthesis): Offers comprehensive manufacturing services for clinical and commercial supply.
- Wuxi AppTec: Known for versatile API and drug product manufacturing.
Formulation and Final Product Suppliers
Once the API is obtained, specialized formulators develop and manufacture Atzumi dosage forms, ensuring bioavailability and regulatory compliance:
- Catalent: A leader in pharmaceutical formulation and packaging solutions.
- Jubilant Biosys: Provides formulation development, clinical manufacturing, and packaging.
- Aenova: Specializes in sterile and non-sterile dosage forms.
Regulatory and Quality Assurance Considerations
Suppliers must adhere to stringent regulatory frameworks, including FDA, EMA, and ICH guidelines. Suppliers with a proven track record of GMP compliance, validated manufacturing processes, and transparent supply chain traceability are preferred for Atzumi.
Emerging Suppliers and Geopolitical Factors
Recent shifts toward regional manufacturing—driven by supply chain disruptions and geopolitical tensions—affect supplier choices. Countries like India, China, and South Korea are increasingly prominent in the supply of raw materials and APIs, but Western regulators emphasize the importance of supplier oversight and validation for critical medicines.
Strategic Sourcing and Due Diligence
Pharmaceutical companies sourcing Atzumi must conduct rigorous due diligence, including:
- Auditing manufacturing facilities.
- Verifying certifications (e.g., GMP, ISO).
- Assessing capacity for scale-up.
- Ensuring supply chain resiliency amid global disruptions.
Partnerships often involve tiered agreements, with primary suppliers validated for quality and secondary suppliers established for contingency.
Conclusion: Navigating the Atzumi Supply Chain
The supply chain for Atzumi encompasses a broad spectrum of specialized suppliers, each integral to delivering a safe, effective product. Companies should focus on establishing relationships with validated, GMP-compliant suppliers across raw material, API, formulation, and logistics stages. As Atzumi remains under development or limited approval, flexibility and rigorous supplier validation will remain keystones for operational success and regulatory compliance.
Key Takeaways
- Manufacturers of Atzumi rely on high-quality chemical suppliers to provide raw materials, predominantly from global chemical giants adhering to GMP standards.
- API production is often handled by specialized CMOs with expertise in complex syntheses and scalable manufacturing.
- Formulation and packaging are executed by experienced pharmaceutical formulators ensuring compliance and product stability.
- Due diligence, regulatory adherence, and supply chain resilience are critical in selecting suppliers for Atzumi.
- Geopolitical factors influence sourcing decisions, emphasizing the need for diversified supplier bases and contingency planning.
FAQs
Q1: What are the main regions supplying raw materials and APIs for Atzumi?
A1: The primary regions include North America, Europe, and Asia (notably India and China), where GMP-compliant chemical and pharmaceutical manufacturing is established.
Q2: How does GMP compliance impact supplier selection for Atzumi?
A2: GMP standards ensure high product quality, safety, and regulatory acceptance, making GMP-compliant suppliers essential for Atzumi production.
Q3: Are there any specific regulatory considerations for sourcing Atzumi suppliers?
A3: Yes, suppliers must meet the regulatory requirements of agencies such as the FDA or EMA, including validated manufacturing processes, comprehensive documentation, and traceability.
Q4: How do geopolitical tensions influence the supply chain for Atzumi?
A4: Tensions may disrupt supply chains, prompt diversification of sourcing, and increase due diligence to ensure supply security and compliance.
Q5: What role do CMOs play in the production of Atzumi?
A5: CMOs provide flexible, scalable manufacturing services for APIs and final dosage forms, often handling complex synthesis, formulation, and packaging processes under strict regulatory standards.
References
[1] Analytical profiles and global chemical suppliers, Sigma-Aldrich [Online]. Available: https://www.sigmaaldrich.com
[2] Contract manufacturing insights and API production, Wuxi AppTec [Online]. Available: https://www.wuxiapptec.com
[3] Regulatory standards for pharmaceutical supply chain, ICH guidelines [Online]. Available: https://www.ich.org
[4] Impact of geopolitical factors on pharma supply chains, WHO Report, 2022.
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