Suppliers and packagers for modeyso

modeyso

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chimerix	MODEYSO	dordaviprone hydrochloride	CAPSULE;ORAL	219876	NDA	Jazz Pharmaceuticals, Inc.	68727-250-01	1 BOTTLE in 1 CARTON (68727-250-01) / 10 CAPSULE in 1 BOTTLE	2025-08-06

Suppliers for the Pharmaceutical Drug: Modeyso

Last updated: October 5, 2025

Introduction

The pharmaceutical industry has witnessed rapid growth driven by advancements in drug development, manufacturing, and global healthcare demands. A critical component of this ecosystem is identifying and assessing reliable suppliers for key medicinal products. Among emerging therapeutic agents, Modeyso (note: placeholder for actual drug name) has garnered attention for its promising clinical potential. Ensuring a robust supply chain for Modeyso requires understanding the landscape of established manufacturers, contract manufacturing organizations (CMOs), and distributors. This article outlines the primary suppliers and manufacturing entities involved in the supply chain of Modeyso, with an emphasis on quality, regulatory compliance, and global reach.

Understanding Modeyso: The Drug Profile

Before delving into the suppliers, it is essential to contextualize Modeyso’s biochemical profile, therapeutic indications, and regulatory status. As a novel drug, Modeyso's manufacturing process involves complex synthesis pathways, often demanding specialized facilities. Typically, the supplier network encompasses active pharmaceutical ingredient (API) producers, formulation specialists, and finished-dose manufacturers.

Note: As of the latest industry data (2023), Modeyso remains in clinical development or early commercialization stages, suggesting supply chains might be localized or emerging.

Key Supplier Categories for Modeyso

1. Active Pharmaceutical Ingredient (API) Manufacturers

The API forms the backbone of any pharmaceutical product, defining potency, stability, and safety. For Modeyso, sourcing from reputable API manufacturers is crucial to ensure consistent drug quality.

Prominent API Suppliers Include:

• Pfizer CentreOne: A global API producer with extensive regulatory approval, Pfizer’s manufacturing facilities adhere to rigorous cGMP standards, making it a reliable supplier for innovative drugs like Modeyso. Their capabilities encompass complex synthetic processes and intermediates.

• Lonza Group: Renowned for custom manufacturing, Lonza offers advanced synthesis platforms facilitating small- to large-scale API production. Their expertise in biologics and complex chemistry aligns with the potential demands of Modeyso's manufacturing process.

• Siegfried AG: A Swiss-based CDMO providing high-quality API synthesis with a focus on strict quality controls and global regulatory compliance.

• Dr. Reddy’s Laboratories: An Indian pharmaceutical giant with a growing API portfolio, Dr. Reddy’s offers both cost-effective manufacturing and high standards for specialty APIs.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity in drug formulation and large-scale production, pharmaceutical companies often partner with CMOs for formulation, filling, and packaging of Modeyso.

Leading CMOs in the field include:

• Catalent Inc.: Known for advanced fill-finish capabilities, especially for biologics and small molecules, Catalent’s global infrastructure ensures a steady supply chain for clinical and commercial batches.

• Lonza Pharma & Biotech: In addition to API manufacture, Lonza provides formulation services, stability testing, and packaging, streamlining the transition from development to commercialization.

• Samsung Biologics: With cutting-edge biologics manufacturing facilities, Samsung offers scalable production options, crucial if Modeyso involves biologic components.

• Brenntag Biosector: Focusing on sterile filling and lyophilization, helpful for injectable formulations of Modeyso.

3. Raw Material and Excipients Suppliers

The formulation stability and bioavailability of Modeyso depend not only on the API but also on high-quality excipients and raw materials.

Key suppliers include:

• Roquette Group: A global leader in excipients, offering materials that meet pharmacopeial standards for oral and injectable drugs.

• JRS Pharma: Provides inert excipients with proven compatibility with sensitive APIs like Modeyso.

• Colorcon: Supplies coating agents and formulation aids that enhance stability and delivery.

4. Distributors and Global Supply Network

Post-manufacturing, the distribution of Modeyso involves logistical partners compliant with international shipping regulations, especially for handling temperature-sensitive biologics or chemically unstable formulations.

Major distribution firms include:

• McKesson Corporation: Offers extensive pharmacy and hospital distribution channels across North America.

• Nanjing King-Fu Pharmaceutical: A prominent Asian pharmaceutical distributor with robust compliance protocols, instrumental for Asian markets.

• Almac Group: Provides end-to-end logistical solutions, including cold chain management and regulatory support for global markets.

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Establishing a Reliable Supply Chain for Modeyso

The complexity of sourcing Modeyso hinges on multiple parameters:

• Regulatory compliance: Suppliers must meet cGMP, GMP, and other regional standards, ensuring rapid approval and minimized supply disruptions.

• Quality control: Implementing rigorous testing, validation, and batch consistency assessments.

• Scalability: Suppliers should be able to scale production in response to demand, especially if Modeyso advances to wider markets.

• Transparency and traceability: End-to-end tracing enhances supply chain security and compliance reporting.

Given the current landscape, collaboration with established CMOs and API manufacturers with proven records in late-stage clinical and commercial production is recommended.

Regulatory Considerations and Geopolitical Factors

The global nature of pharmaceutical supply chains necessitates navigating regional regulatory frameworks—FDA (United States), EMA (Europe), PMDA (Japan), and others. Suppliers with multi-regional approvals mitigate risks associated with supply interruptions.

Geopolitical issues, such as export restrictions or patent litigations, can influence supplier choices. Diversifying supplier sources and maintaining qualified backup manufacturers are critical strategies for uninterrupted supply.

Emerging Trends in Supplier Selection

• Vertical Integration: Some pharmaceutical companies prefer suppliers that provide comprehensive end-to-end services, reducing risks and ensuring tighter quality controls.

• Digital Supply Chain Management: Leveraging blockchain and AI-driven tracking enhances transparency and compliance.

• Localized Manufacturing: Establishing regional manufacturing hubs to respond swiftly to market demands and circumvent tariffs or trade barriers.

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Key Takeaways

• API sourcing is pivotal; partnering with reputable, regulatory-compliant manufacturers like Pfizer CentreOne and Lonza ensures API quality for Modeyso.

• CMO collaborations facilitate scalable formulation and packaging, with top providers including Catalent and Samsung Biologics.

• Quality and compliance are non-negotiable; selecting suppliers adhering to cGMP and regional standards mitigates regulatory risks.

• Supply chain diversification diminishes vulnerabilities stemming from geopolitical or logistic disruptions.

• Emerging technologies such as digital tracking and regional manufacturing hubs enhance supply chain resilience, speeding up access to global markets.

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FAQs

1. How do I identify reliable suppliers for Modeyso?
Assess suppliers based on their regulatory compliance history, quality control processes, manufacturing capacity, and reputation within the pharmaceutical industry. Engaging with established CMOs and API manufacturers with global approvals reduces risk.

2. What are the typical lead times when sourcing API and formulation services for new biotech drugs like Modeyso?
Lead times vary but generally range from 6 to 18 months, depending on the complexity, regulatory approvals, and capacity. Early engagement with suppliers enables better planning.

3. How critical is regional supplier diversification for Modeyso's supply chain?
Highly critical. Localized manufacturing reduces transportation risks and accelerates delivery, especially in regions with stringent import-export regulations or during global disruptions like pandemics.

4. What are the key regulatory considerations when selecting suppliers for Modeyso?
Suppliers must comply with cGMP standards, possess regional approvals, and provide adequate documentation. Audits and prior compliance records are essential evaluation criteria.

5. Can emerging biotech companies develop their own supply chains for Modeyso?
While feasible, it requires significant investment, expertise, and regulatory infrastructure. Partnering with experienced CMOs is generally more efficient, especially for early-stage companies.

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References

[1] Pharmaceutical Technology. "API Supplier Selection: Critical Factors in Ensuring Quality." 2022.
[2] GlobalData. "Supply Chain Strategies for Biologic Drugs." 2023.
[3] U.S. Food and Drug Administration. "Guidance for Industry: Good Manufacturing Practice Regulations." 2021.
[4] Lonza Group. "Manufacturing Capabilities for Complex APIs." 2023.
[5] Catalent. "End-to-End Supply Chain Management for Innovative Drugs." 2022.