Suppliers and packagers for giapreza

giapreza

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360	NDA	La Jolla Pharmaceutical Company	68547-005-01	1 VIAL, SINGLE-DOSE in 1 CARTON (68547-005-01) / 1 mL in 1 VIAL, SINGLE-DOSE	2022-09-15
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360	NDA	La Jolla Pharmaceutical Company	68547-501-02	1 VIAL, SINGLE-DOSE in 1 CARTON (68547-501-02) / 1 mL in 1 VIAL, SINGLE-DOSE	2018-02-05

Suppliers for the Pharmaceutical Drug: Giapreza

Last updated: August 5, 2025

Introduction

Giapreza (angiotensin II), a synthetic peptide used to treat shock-induced hypotension, has gained prominence within critical care medicine for its targeted vasoconstrictive properties. Approved by the U.S. Food and Drug Administration (FDA) in December 2017, Giapreza is marketed by AngioDynamics Inc., following recent licensing agreements with its manufacturer, La Jolla Pharmaceutical Company. Understanding the supply chain dynamics, including primary suppliers and manufacturing partnerships, is critical for stakeholders ranging from healthcare providers to investors. This analysis delineates the key suppliers involved in Giapreza’s production and distribution, evaluates supply chain risks, and offers strategic insights.

Manufacturing and Raw Material Suppliers

Active Pharmaceutical Ingredient (API) Production

Giapreza’s core component, angiotensin II, is a synthetically manufactured peptide. Its production involves complex peptide synthesis processes typically utilizing solid-phase peptide synthesis (SPPS) techniques. La Jolla Pharmaceutical’s manufacturing relies on specialized chemical suppliers capable of providing high-quality amino acids and peptide intermediates.

• Key API Suppliers:
  La Jolla has not publicly disclosed all API suppliers; however, industry norms suggest reliance on specialized chemical partners capable of GMP-compliant peptide synthesis. Potential suppliers include companies such as Bachem, Aldrich (Sigma-Aldrich, part of Merck), and Peptides International, which supply high-grade amino acids and peptide reagents globally. These suppliers must adhere to strict quality and regulatory standards to ensure API integrity.

Intermediate and Raw Material Suppliers

• Amino Acids:
  Critical amino acids like L-arginine, used in peptide synthesis, are sourced from global chemical companies with large-scale manufacturing capabilities, including Ajinomoto, Evonik, and Chemours.

• Solvents and Reagents:
  High-purity solvents such as acetonitrile, DCM, and coupling reagents like HBTU are sourced from chemical suppliers including Thermo Fisher Scientific and VWR.

Manufacturing Facilities

Giapreza’s manufacturing is conducted in cGMP-compliant facilities, with La Jolla collaborating with facilities in the U.S. and Europe. The complexity of peptide synthesis necessitates specialized manufacturing infrastructure, limiting supplier options to a select few qualified providers.

Distribution and Supply Chain Partners

Global and Regional Distributors

Giapreza’s distribution relies on specialized pharmaceutical distributors, with the primary market in the U.S. managed by Cardinal Health and McKesson, facilitating hospital and healthcare provider access.

• Giapreza Distribution:
  As a highly specialized, hospital-only product, Giapreza is supplied primarily through large distribution networks capable of handling temperature-sensitive biologics and APIs. AngioDynamics partners with large third-party logistics companies such as AmerisourceBergen in some markets for distribution, ensuring compliance with storage and handling regulations.

Authorship of Manufacturing and Supply Agreements

Giapreza’s supply chain involves contracts primarily between La Jolla Pharmaceutical and manufacturing facilities, with licensing and approval rights transferred to AngioDynamics. The critical dependence on La Jolla’s suppliers emphasizes the importance of supplier reliability for uninterrupted supply.

Supply Chain Challenges and Risks

Raw Material Availability

The synthesis of angiotensin II requires high-purity amino acids and specialty reagents, which are subject to global supply constraints. Disruptions due to geopolitical tensions, pandemics, or raw material shortages could impair API production.

Manufacturing Capacity Constraints

Peptide synthesis is resource-intensive, with limited high-capacity manufacturers. Any regulatory or operational issues at these facilities could cause supply delays. La Jolla’s reliance on a network of specialized contract manufacturers amplifies this risk.

Regulatory and Quality Compliance

Strict FDA and international standards restrict supplier options. Delays in approvals or quality issues from raw material providers can halt production. During the COVID-19 pandemic, supply chain disruptions for chemical and pharmaceutical ingredients became prominent, posing ongoing risks.

Market Demand and Clinical Usage

Giapreza’s niche indication as a vasopressor in shock management limits supply flexibility. Abrupt increases in demand due to critical care surges can strain supply chains, especially if manufacturing capacity is constrained.

Competitive Landscape and Future Considerations

Potential for Alternative Suppliers or Biosimilars

Currently, no biosimilar or generic versions of angiotensin II are available. La Jolla’s control over API manufacturing and proprietary synthesis processes act as barriers to entry, lending a temporary monopoly to supply. However, technological advances could enable new entrants, potentially diversifying the supplier landscape.

Partnerships and Strategic Alliances

AngioDynamics’ recent licensing agreements with La Jolla facilitate streamlined distribution but do not necessarily expand the supply base. Future strategic alliances with alternative API manufacturers could mitigate supply risks.

Conclusion

The supply chain for Giapreza is characterized by reliance on specialized peptide synthesis providers, high-quality raw material suppliers, and established distribution networks. The complexity of peptide manufacturing, coupled with regulatory requirements, emphasizes the importance of a resilient supply chain. Ensuring diversified raw material sources and expanding manufacturing capacity are vital strategies to mitigate supply disruptions.

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Key Takeaways

• Primary API suppliers are likely specialized chemical manufacturers capable of high-quality peptide synthesis, such as Bachem or Peptides International, although La Jolla has not publicly disclosed exact partners.
• Raw material availability — especially amino acids and reagents — remains a critical risk area, influenced by global supply chain dynamics.
• Manufacturing capacity constraints pose challenges to scaling supply, given the complex nature of peptide synthesis.
• Distribution partnerships with large healthcare logistics providers ensure hospital access but depend on maintaining regulatory compliance.
• Investors and healthcare providers should monitor potential supply chain disruptions, especially amid geopolitical and pandemic-related uncertainties.

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FAQs

1. Who are the main manufacturers of the API used in Giapreza?
La Jolla Pharmaceutical has not publicly disclosed specific API manufacturers. However, industry-standard peptide synthesis is conducted by specialized chemical companies such as Bachem, Sigma-Aldrich, and Peptides International.

2. How does raw material availability impact Giapreza supply?
Limited availability of high-purity amino acids and reagents can cause manufacturing delays, especially amid global supply chain disruptions impacted by geopolitical issues or pandemics.

3. Are there any biosimilars or generic alternatives to Giapreza?
Currently, no biosimilar or generic version exists. La Jolla’s proprietary manufacturing process and control over API supply create high barriers to entry.

4. What strategic measures can mitigate supply chain risks for Giapreza?
Diversifying raw material suppliers, increasing manufacturing capacity, establishing multiple manufacturing sites, and forging strategic alliances with alternative API producers are measures to ensure supply continuity.

5. How does distribution ensure timely availability of Giapreza in hospitals?
Distribution is managed through large pharmaceutical logistics companies like Cardinal Health and AmerisourceBergen, ensuring temperature-controlled, prompt delivery to critical care facilities.

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References

1. U.S. Food and Drug Administration (FDA). Giapreza (angiotensin II) injection, for infusion, interim labeling and approval information. 2017.
2. La Jolla Pharmaceutical Company. Giapreza product information. 2022.
3. Industry reports on peptide synthesis and pharmaceutical ingredient suppliers.
4. Strategic analysis of critical care pharmacological supply chains.