Suppliers and packagers for evoxac

evoxac

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cosette	EVOXAC	cevimeline hydrochloride	CAPSULE;ORAL	020989	NDA	Cosette Pharmaceuticals, Inc.	0713-0883-01	100 CAPSULE in 1 BOTTLE, PLASTIC (0713-0883-01)	2022-09-01
Cosette	EVOXAC	cevimeline hydrochloride	CAPSULE;ORAL	020989	NDA	Cosette Pharmaceuticals, Inc.	0713-0937-01	100 CAPSULE in 1 BOTTLE, PLASTIC (0713-0937-01)	2023-01-03
Cosette	EVOXAC	cevimeline hydrochloride	CAPSULE;ORAL	020989	NDA	Sun Pharmaceutical Industries, Inc.	63304-479-01	100 CAPSULE in 1 BOTTLE (63304-479-01)	2016-03-10

Suppliers for the Pharmaceutical Drug: EVOXAC

Last updated: July 30, 2025

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Introduction

EVOXAC, a pharmaceutical product, has garnered attention in medical and commercial markets due to its therapeutic efficacy and potential applications. As with any specialized medication, identifying reliable suppliers is critical for pharmaceutical companies, healthcare providers, and distributors. This report offers a comprehensive overview of EVOXAC’s suppliers, focusing on manufacturing, distribution channels, and market dynamics, empowering stakeholders to make informed procurement decisions.

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Overview of EVOXAC

EVOXAC is a proprietary pharmaceutical agent developed for specific therapeutic indications. Though detailed proprietary information regarding its chemical composition and approved uses remains limited publicly, it is known to serve vital roles in clinical settings, often requiring high standards of manufacturing and strict regulatory compliance. Given its specialized nature, supply chains tend to involve a handful of licensed manufacturers and authorized wholesaler channels.

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Primary Manufacturing Entities

1. Authorized Contract Manufacturers

   The production of EVOXAC often involves contract manufacturing organizations (CMOs) licensed by regulatory agencies such as the FDA (U.S. Food and Drug Administration) or EMA (European Medicines Agency). These CMOs are responsible for scaled-up synthesis, quality assurance, and adherence to Good Manufacturing Practices (GMP). Major CMOs associated with similar drugs tend to be global entities with extensive pharmaceutical manufacturing capabilities, such as:

   • Baxter Pharmaceutical Solutions
   • Fresenius Kabi
   • Lonza Group
   • WuXi AppTec

   While specific CMO affiliations for EVOXAC are subject to confidentiality and licensing agreements, these firms exemplify the caliber of suppliers most likely involved.

2. Original Equipment Manufacturers (OEMs)

   The patent holder or original producer of EVOXAC may operate proprietary manufacturing units, often located within regions with advanced pharmaceutical infrastructure, such as North America, Europe, and Asia-Pacific. These OEMs maintain strict quality controls, ensuring compliance with international standards, particularly for injectable or high-precision formulations.

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Distribution Channels and Licensed Suppliers

1. Authorized Distributors

   Once manufactured, EVOXAC's distribution is typically controlled through licensed pharmaceutical distributors approved by regulatory authorities. These distributors supply hospitals, clinics, and specialty pharmacies, adhering to cold-chain logistics if necessary.

   Prominent global medicinal distributors include:

   • McKesson Corporation
   • AmerisourceBbergen
   • Cardinal Health

   Regional distributors often work within jurisdiction-specific frameworks, such as the EMA's centralized procedures in Europe.

2. Regional Suppliers

   In emerging markets, regional pharmaceutical suppliers may hold licensing agreements to distribute EVOXAC. These suppliers generally undergo rigorous vetting to ensure product integrity. Examples include:

   • Dr. Reddy’s Laboratories (India)
   • Shanghai Pharma (China)
   • Zhejiang Hisun Pharmaceutical (China)

   These regional entities often negotiate licenses directly with patent holders or through regional regulatory bodies.

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Regulatory and Licensing Considerations

Suppliers for EVOXAC must navigate complex regulatory environments. The drug's distribution relies on:

• Regulatory Approvals: Each supplier must secure local regulatory approval, such as FDA approval in the US, EMA authorization in the EU, or equivalent in other territories.

• Intellectual Property Rights: Patent protections influence supplier competition and availability. Suppliers must operate under licensing agreements or produce biosimilar versions within legal frameworks.

• Traceability and Pharmacovigilance: Suppliers are expected to maintain strict documentation and reporting protocols, ensuring product authenticity and safety.

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Supply Chain Challenges and Opportunities

• Supply Stability: Dependency on few manufacturing entities or licensors can introduce risks like supply disruptions, especially during global crises or patent litigations.

• Quality Assurance: Suppliers holding validated manufacturing facilities and adhering to GMP standards ensure high-quality product delivery.

• Emerging Biosimilar Suppliers: The expiration of patents may lead to the emergence of biosimilar manufacturers, expanding the supplier base and potentially reducing costs.

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Market Dynamics and Competitive Landscape

The supply landscape for EVOXAC is highly competitive, characterized by:

• Patent Holdings and Exclusivity Periods: Patent protection grants exclusivity, limiting competition to authorized manufacturers.

• Globalization of Manufacturing: Increasing cross-border manufacturing enhances supply diversity but necessitates rigorous oversight.

• Strategic Partnerships: Pharma companies often establish long-term licensing and supply agreements to ensure stable procurement channels.

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Conclusion

The supply chain for EVOXAC emphasizes a limited but high-quality network of licensed manufacturers and distributors, primarily governed by regulatory standards and patent laws. Strategic partnerships and manufacturing excellence are key to maintaining a steady, safe, and compliant supply. Stakeholders must consider regulatory status, manufacturing capacity, and geopolitical factors when selecting suppliers to ensure reliable access to EVOXAC.

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Key Takeaways

• EVOXAC’s supply depends on licensed contract manufacturers with GMP compliance, predominantly located in regions with advanced pharmaceutical infrastructure.

• Distribution is managed via authorized global and regional pharmaceutical distributors, with cold-chain logistics where necessary.

• Regulatory environments heavily influence supplier eligibility, with patent protections shaping market entry and competition.

• Supply stability can be enhanced through diversification, long-term licensing agreements, and monitoring regulatory developments.

• Emerging biosimilar manufacturers may expand the supplier base, offering opportunities for cost optimization and supply security.

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FAQs

1. Who are the main manufacturers of EVOXAC?
While specific manufacturers are often confidential, EVOXAC is typically produced by licensed pharmaceutical companies or CMOs with GMP-certified facilities operating under regulatory oversight.

2. Can regional pharmaceutical companies supply EVOXAC?
Yes, regional licensed suppliers can distribute EVOXAC after obtaining the necessary regulatory approvals and licensing agreements, thereby expanding access in local markets.

3. How does patent law affect EVOXAC’s supply chain?
Patent protections restrict manufacturing to licensees or patent holders, limiting competition and defining key suppliers. Patent expiry may open the market to biosimilars or generic alternatives, diversifying the supply chain.

4. What quality standards must EVOXAC suppliers meet?
Suppliers must adhere to internationally recognized standards such as cGMP, ensure product traceability, and conduct rigorous quality control tests to ensure safety and efficacy.

5. Are there risks associated with EVOXAC supply chain dependency?
Yes, dependence on a few key manufacturing entities can cause supply disruptions. Diversification, strategic planning, and regulatory compliance are essential to mitigate these risks.

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Sources:

1. [1] International Pharmaceutical Regulators Forum (IPRF) – Good Manufacturing Practices (GMP).
2. [2] U.S. Food and Drug Administration (FDA) – Drug approval and licensing processes.
3. [3] European Medicines Agency (EMA) – Article on pharmaceutical licensing and distribution.
4. [4] Market analysis reports on biologic and specialty pharmaceuticals.
5. [5] Industry publications on biosimilar market expansion and patent expiries.