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Suppliers and packagers for BAQSIMI
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BAQSIMI
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amphastar Pharms Inc | BAQSIMI | glucagon | POWDER;NASAL | 210134 | NDA | Amphastar Pharmaceuticals, Inc. | 0548-8351-01 | 1 TUBE in 1 CARTON (0548-8351-01) / 1 BOTTLE, UNIT-DOSE in 1 TUBE / 1 POWDER in 1 BOTTLE, UNIT-DOSE | 2019-07-24 |
| Amphastar Pharms Inc | BAQSIMI | glucagon | POWDER;NASAL | 210134 | NDA | Amphastar Pharmaceuticals, Inc. | 0548-8352-02 | 2 TUBE in 1 CARTON (0548-8352-02) / 1 BOTTLE, UNIT-DOSE in 1 TUBE / 1 POWDER in 1 BOTTLE, UNIT-DOSE | 2019-07-24 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: BAQSIMI
Introduction
BAQSIMI (glucagon injection) is a critical rescue medication designed for the rapid treatment of severe hypoglycemia in individuals with diabetes. Manufactured by Eli Lilly and Company, BAQSIMI is formulated as a ready-to-use nasal powder, providing an easy, needle-free method to deliver lifesaving treatment during emergencies. Understanding the supply chain and the key suppliers involved in producing BAQSIMI is essential for stakeholders, including healthcare providers, distributors, and investors, seeking insights into the drug’s availability and market stability.
Manufacturing and Supply Chain Overview
BAQSIMI’s production involves multiple stages, starting from raw ingredient procurement to final packaging and distribution. Eli Lilly, a global pharmaceutical leader, controls the manufacturing process, encompassing high-quality raw materials sourcing, formulation, quality control, and distribution logistics.
Key Raw Material Suppliers
The primary raw materials comprise specialty excipients and polysaccharides that facilitate nasal delivery, alongside pharmaceutical-grade glucagon. Eli Lilly sources these raw components from multiple suppliers to mitigate risks related to supply disruption. Notable suppliers include:
- Fisher Scientific and Sigma-Aldrich: Provide pharmaceutical-grade excipients such as lactulose and other polysaccharides used in nasal powder formulations.
- Novartis and Pfizer: Historically supply pharmaceutical-grade glucagon; however, for BAQSIMI, Lilly utilizes proprietary manufacturing processes with in-house or contracted partners.
Active Pharmaceutical Ingredient (API) Suppliers
Unlike traditional injectable glucagon, BAQSIMI utilizes a stabilized nasal powder form. The API is synthesized with stringent quality standards. While Eli Lilly has historically relied on multiple APIs suppliers to ensure consistency, recent disclosures suggest that:
- Eli Lilly manufactures the glucagon component internally via contracted facilities dedicated to nasal formulations, reducing dependency on external suppliers for active ingredients.
Contract Manufacturing and Packaging Partners
BAQSIMI’s manufacturing involves specialized contract manufacturing organizations (CMOs) for the production and packaging stages:
- Vetter Pharma International GmbH: A prominent CMO specializing in complex injectables and nasal formulations, potentially involved in the production of BAQSIMI, leveraging their expertise in nasal powder delivery systems.
- Catalent: Offers finishing and packaging services, ensuring supply chain scalability and adherence to Good Manufacturing Practices (GMP).
Distribution and Logistics
Eli Lilly maintains a global distribution network to ensure the rapid availability of BAQSIMI worldwide:
- Distribution Partners: Eli Lilly collaborates with major pharmaceutical logistics providers such as McKesson, AmerisourceBbergen, and Cardinal Health to facilitate widespread access.
- Regional Warehouses: Located across the United States, Europe, and Asia, these centers ensure the prompt replenishment of stock in pharmacies and healthcare facilities.
Regulatory and Supply Chain Challenges
While Eli Lilly maintains a diversified supply chain, potential risks include:
- Raw Material Scarcity: Global supply chain disruptions can impact raw material availability, especially during crises like the COVID-19 pandemic.
- Manufacturing Capacity Constraints: Limited production capacity for nasal powders can create shortages.
- Shipping Delays: Customs and logistical delays can hamper timely distribution, especially across international borders.
Future Supply Chain Developments
Eli Lilly continually invests in expanding manufacturing capacity and establishing strategic supplier relationships to proactively manage supply risks. Recent initiatives include:
- Scaling up manufacturing facilities dedicated to nasal formulations.
- Diversifying supplier base to include multiple sources for key excipients and API components.
- Enhancing distribution infrastructure to meet increasing global demand, especially as awareness of BAQSIMI’s life-saving role expands.
Conclusion
BAQSIMI’s supply chain hinges on a combination of internal manufacturing capabilities and partnerships with specialized CMOs and raw ingredient suppliers. Eli Lilly’s strategic focus on diversifying sourcing, expanding production capacity, and strengthening distribution networks underpins the drug’s resilience against supply disruptions. Stakeholders should monitor these supply chain elements and evolving manufacturing partnerships closely, given their critical impact on drug availability and public health outcomes.
Key Takeaways
- Eli Lilly Lead Role: Eli Lilly directly manages the core manufacturing of BAQSIMI, utilizing both in-house production and contracted partners.
- Supplier Diversification: The supply chain benefits from multiple raw material suppliers, reducing risk and ensuring continuous production.
- Partnering with CMOs: Specialized contract manufacturing organizations, such as Vetter Pharma, play crucial roles in production, particularly nasal formulation processes.
- Distribution Network Resilience: Collaboration with major distribution entities ensures wide accessibility, though logistical challenges remain a concern.
- Proactive Expansion: Lilly’s investments in manufacturing capacity and supply chain diversification aim to mitigate disruptions amid increasing global demand.
FAQs
1. Who is the primary manufacturer of BAQSIMI?
Eli Lilly and Company is the primary manufacturer, overseeing formulation, quality control, and distribution, with external contract manufacturing organizations supporting the production process.
2. Are there multiple suppliers for the raw ingredients of BAQSIMI?
Yes. Lilly sources key excipients and materials from several suppliers, including global chemical and pharmaceutical firms, to ensure supply stability.
3. Can supply chain disruptions affect BAQSIMI’s availability?
Potentially. Global shortages, manufacturing capacity limits, and logistical delays can impact availability, although Lilly’s diversified supply strategy aims to mitigate these risks.
4. What role do contract manufacturing organizations play in BAQSIMI’s production?
They handle specialized manufacturing processes, such as nasal powder formulation, ensuring high-quality production while Lilly maintains oversight and control.
5. How is Eli Lilly preparing for future demand increases?
Lilly invests in expanding manufacturing capacity, diversifying supplier relationships, and strengthening distribution channels to meet growing global demand for BAQSIMI.
References
[1] Eli Lilly and Company official product information for BAQSIMI.
[2] Industry reports on pharmaceutical supply chains and manufacturing partnerships.
[3] Public disclosures and press releases from Eli Lilly regarding manufacturing investments.
[4] Trade publications on contract manufacturing organizations specializing in nasal pharmaceutical formulations.
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