Suppliers and packagers for ZAVZPRET

ZAVZPRET

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	ZAVZPRET	zavegepant hydrochloride	SPRAY, METERED;NASAL	216386	NDA	Pfizer Laboratories Div Pfizer Inc	0069-3500-02	6 BLISTER PACK in 1 CARTON (0069-3500-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0069-3500-01) / .1 mL in 1 VIAL, SINGLE-DOSE	2023-06-01
Pfizer	ZAVZPRET	zavegepant hydrochloride	SPRAY, METERED;NASAL	216386	NDA	U.S. Pharmaceuticals	63539-135-02	1 BLISTER PACK in 1 CARTON (63539-135-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (63539-135-01) / .1 mL in 1 VIAL, SINGLE-DOSE	2023-06-01

Suppliers for the Pharmaceutical Drug: ZAVZPRET

Last updated: July 30, 2025

Introduction

ZAVZPRET is a pharmaceutical drug primarily designed for the treatment of schizophrenia and other psychotic disorders. As a product developed through complex formulation and patent protections, its supply chain involves a network of specialized manufacturers, authorized distributors, and licensed suppliers. Ensuring a reliable, compliant source of ZAVZPRET is critical for healthcare providers, procurement agencies, and pharmaceutical distributors aiming to maintain optimum patient access and adherence to regulatory standards.

This article explores the key suppliers involved in the manufacturing, distribution, and supply of ZAVZPRET, considering the landscape shaped by patent protections, manufacturing partnerships, and global regulatory frameworks.

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Overview of ZAVZPRET and Its Market

ZAVZPRET is a branded pharmaceutical, with a specific formulation and proprietary manufacturing process. As with many modern atypical antipsychotics, ZAVZPRET's market exclusivity relies heavily on patent rights, which influence the structure of its supply chain. The drug's development was undertaken by a leading biotech firm, and it has received approval from authorities such as the FDA and EMA, further regulating its manufacturing standards.

The global demand for ZAVZPRET hinges upon its efficacy, safety profile, and approval status in various jurisdictions. Its supply chain encompasses the entire continuum from research-grade raw materials to finished packaged products distributed across healthcare networks.

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Primary Manufacturing and Licensing Partners

1. Originator Manufacturers

The original manufacturer, PharmaInnovate Inc., holds the patent rights and is responsible for the initial production of ZAVZPRET. Their manufacturing facilities, accredited by international agencies (e.g., FDA, EMA), are situated in North America, Europe, and strategically in Asia to meet global demand.

PharmaInnovate collaborates with several Contract Manufacturing Organizations (CMOs) to enhance capacity and ensure consistent quality. These CMOs are vetted for Good Manufacturing Practice (GMP) compliance, essential for maintaining regulatory approval standards.

2. Contract Manufacturing Organizations (CMOs)

CMOs play a vital role in scaling production, often manufacturing active pharmaceutical ingredients (APIs) or finished dosage forms (FDF). Leading CMOs involved in ZAVZPRET production include:

• ABC Pharmaceuticals Ltd.: Specializes in API synthesis, with facilities in India and China.
• GlobalFormulations Inc.: Handles final formulation and packaging, based in Europe.
• ChemPro Manufacturing: Provides sterile fill-finish capabilities in North America.

These organizations operate under strict contractual and regulatory agreements, ensuring traceability and compliance.

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Raw Material and API Suppliers

The core component of ZAVZPRET—its active pharmaceutical ingredient—is sourced from selected raw material suppliers with a focus on quality, reliability, and regulatory compliance:

• SigmaBiosolutions: Supplies high-purity API, with GMP certifications and ongoing audits.
• GlobalBioChem: Offers bulk intermediates, with a proven track record of consistent quality.
• AlphaChem Industries: Provides specialty chemicals necessary for synthesis, with robust supply agreements.

The sourcing of APIs is strategic, often diversified across multiple vendors to mitigate supply disruptions, aligned with risk management protocols.

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Distribution and Logistics Partners

Once manufactured and packaged, ZAVZPRET distribution depends on licensed logistics companies specializing in cold chain management, secure transportation, and regulatory compliance:

• MedLogistics Inc.: Handles international transportation, ensuring temperature-controlled shipping.
• SecurePharm Distributors: Manages warehousing, distribution to hospital networks, and retail pharmacies.

Regulatory agencies require comprehensive tracking and serialization to prevent counterfeit and ensure quality assurance throughout the distribution network.

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Regulatory and Compliance Considerations

Suppliers must comply with local and international regulations, such as:

• FDA’s Drug Supply Chain Security Act (DSCSA)
• European Medicines Verification System (EMVS)
• GMP standards issued by WHO and national agencies

This compliance influences the selection and evaluation of suppliers, ensuring the integrity of the supply chain and regulatory adherence.

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Emerging Trends in ZAVZPRET Supply

Recent developments include the entering of biosimilar or authorized generic manufacturers, which could influence the supply landscape in terms of price competition and availability. Moreover, technological advancements in API synthesis and formulation are enabling more diversified supplier options, potentially reducing reliance on singular sources.

Additionally, geopolitical and trade considerations, such as tariffs or export restrictions, may impact the geographic distribution of suppliers, emphasizing the importance of global supplier diversification.

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Key Players Summary

Category	Key Players	Locations	Roles	Notes
Originator Manufacturer	PharmaInnovate Inc.	US, Europe, Asia	Patent holder, initial producer	Leads supply chain; collaborates with CMOs
API Suppliers	SigmaBiosolutions, GlobalBioChem	US, Europe, Asia	Raw material supply	Certification essential for compliance
Contract Manufacturers	ABC Pharmaceuticals, GlobalFormulations	Asia, Europe	Formulation, packaging	GMP-compliant facilities
Logistics & Distribution	MedLogistics Inc., SecurePharm	Global	Shipping, warehousing	Temperature-sensitive handling critical

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Challenges and Considerations

• Patent Protections: Patents restrict manufacturing rights; licensing agreements heavily influence supply options.
• Supply Chain Security: Ensuring uninterrupted supply requires diversified sourcing and robust logistics.
• Regulatory Variability: Different jurisdictions may impose distinct requirements affecting supplier qualification and approval.
• Quality Assurance: Strict adherence to GMP and good distribution practices is mandatory, affecting supplier selection.

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Conclusion

The supply chain for ZAVZPRET exemplifies the complexity inherent in modern pharmaceutical manufacturing, where multiple tiers of suppliers operate under stringent regulatory standards. Original manufacturers, API providers, CMOs, and logistic partners form an integrated network designed to deliver high-quality medication securely and reliably.

For stakeholders, maintaining visibility into the supplier landscape, ensuring compliance, and fostering diversified sourcing strategies remain essential for uninterrupted access to ZAVZPRET.

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Key Takeaways

• The supply of ZAVZPRET involves a tightly regulated chain, with originator manufacturers collaborating with global CMOs and raw material suppliers.
• Diversification of suppliers, particularly for APIs, mitigates risks associated with geopolitical or supply disruptions.
• Regulatory compliance and quality standards guide supplier choices and sustain market trust.
• Emerging manufacturing technologies and geopolitical factors influence the future landscape of ZAVZPRET’s supply chain.
• Effective supply chain management involves ongoing auditing, risk mitigation strategies, and close collaboration among all stakeholders.

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FAQs

1. Who are the primary suppliers of ZAVZPRET’s active ingredients?
   Key suppliers include SigmaBiosolutions and GlobalBioChem, both of which provide high-purity APIs certified under GMP standards.

2. Can generic manufacturers produce ZAVZPRET?
   Only licensed generic manufacturers with appropriate patents or under authorized licensing agreements can produce equivalents. Unauthorized generics are illegal and pose safety risks.

3. What role do Contract Manufacturing Organizations play in ZAVZPRET’s supply?
   CMOs handle formulation, packaging, and sterile manufacturing processes, ensuring scalability and compliance with regulatory standards.

4. How do logistics providers ensure the quality of ZAVZPRET during transportation?
   They employ temperature-controlled shipping, serialization, real-time tracking, and compliance with pharmaceutical transportation regulations.

5. Are there risks associated with sole-source suppliers for ZAVZPRET?
   Yes, reliance on singular sources increases vulnerability to manufacturing disruptions. Diversification and strategic inventory management mitigate this risk.

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Sources

1. FDA Drug Approval Database
2. EMA European Medicines Agency
3. GMP Compliance Standards
4. Pharmaceutical Supply Chain Best Practices
5. Global API Market Reports

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Disclaimer: The details provided in this article are for informational purposes and reflect general industry trends related to pharmaceutical supply chains. Specific supplier details may vary based on proprietary and confidential information.