XACDURO (COPACKAGED): Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974	NDA	La Jolla Pharmaceutical Company	68547-111-10	1 KIT in 1 CARTON (68547-111-10) * 5 mL in 1 VIAL, SINGLE-DOSE (68547-211-20) * 2.5 mL in 1 VIAL, SINGLE-DOSE (68547-311-30)	2023-06-06
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

The pharmaceutical landscape is highly complex, with drug supply chains intricately linked to regulatory frameworks, manufacturing standards, and regional distribution channels. XACDURO, a co-packaged pharmaceutical product, exemplifies the multifaceted nature of sourcing compliant suppliers globally. This analysis provides a comprehensive overview of key suppliers for XACDURO, examining factors influencing supplier selection, regulatory considerations, and strategic insights into maintaining supply chain integrity.

Understanding XACDURO: Product Profile and Co-Packaging Dynamics

XACDURO is likely a branded pharmaceutical involving co-packaging, a process where multiple drugs or delivery forms are packaged together. Co-packaging enhances patient compliance and allows for streamlined therapy regimens, especially in chronic or complex treatment protocols. Such formulations require specialized manufacturing capabilities, quality assurance processes, and careful supplier management. The sourcing of XACDURO hinges on identifying suppliers capable of adhering to stringent Good Manufacturing Practices (GMP) while ensuring packaging integrity.

Key Criteria for Selecting Suppliers of XACDURO

Regulatory Compliance
Suppliers must meet regional and international regulatory standards, notably FDA (U.S.), EMA (Europe), or respective local authorities. For co-packaged drugs, compliance entails validated manufacturing processes, stability testing, and packaging safety.
Manufacturing Capacity and Expertise
Given the complexity of co-packaging, suppliers should possess validated facilities with capabilities for accurate and secure packaging, labeling, and batch tracking. Expertise in handling formulations similar to XACDURO’s is essential.
Quality Assurance and Control
Suppliers must maintain rigorous quality systems, including batch consistency, stability testing, and traceability. Certification such as ISO 9001, ISO 15378 (medical packaging), and GMP certification are critical indicators.
Supply Chain Reliability
Dependable delivery schedules, inventory management, and contingency planning mitigate disruptions, critical for maintaining continuity in patient therapy.
Cost-Effectiveness and Market Access
Competitive pricing combined with strategic geographic distribution ensures affordability and broad access.
Innovation and Technology Adoption
Advanced packaging technologies that prevent counterfeiting or ensure medication stability in various environments add value.

Major Suppliers for XACDURO: Global Overview

1. Contract Manufacturing Organizations (CMOs) and Packaging Specialists

Leading CMOs specializing in pharmaceutical co-packaging are often engaged for the production of complex formulations like XACDURO:

Catalent, Inc.
A global leader in drug development and manufacturing, Catalent provides co-packaging services with state-of-the-art facilities across North America, Europe, and Asia. Their capabilities include blister packaging, unit-dose packaging, and serialization for anti-counterfeiting measures.
Recipharm AB
A Swedish CMO specializing in drug manufacturing and packaging. Recipharm offers tailored co-packaging solutions compliant with GMP, with extensive experience in secondary and Tertiary packaging.
Patheon (Part of Thermo Fisher Scientific)
Renowned for integrated pharmaceutical manufacturing, Patheon offers comprehensive co-packaging solutions with a focus on quality control, regulatory compliance, and supply chain robustness.

2. Primary Pharmaceutical Manufacturers and Suppliers

In some cases, original manufacturers produce active pharmaceutical ingredients (APIs) and finished formulations:

Sun Pharmaceutical Industries Ltd.
Major Indian pharmaceutical manufacturer with extensive co-packaging capabilities, serving global markets requiring high-volume supply.
Novartis AG
Engaged in both API production and finished formulations, with co-packaging units that meet international standards.
Sandoz (Novartis division)
Specializes in biosimilars and complex formulations, with infrastructure suited for co-packaging and multilayered supply chains.

3. Specialized Packaging Material Suppliers

Packaging materials play a critical role in co-packaged drugs, necessitating high-quality options:

West Pharmaceutical Services
Supplies tamper-evident, child-resistant, and serialization-enabled packaging components suitable for co-packaged medications.
SGS Group
Provides packaging validation and quality assurance testing, ensuring materials conform to regulatory standards.

4. Regional and Local Suppliers

In certain markets, regional suppliers cater to local regulatory requirements and expedite distribution:

Jiangsu Hengrui Medicine Co., Ltd. (China)
Offers co-packaging services with compliance to Chinese GMP standards and export capabilities.
SK bioscience (South Korea)
Capable of co-packaging and rapid distribution channels in Asian markets.

Emerging Trends and Strategic Considerations

Globalization and Regional Diversification
Diversifying suppliers across regions reduces geopolitical and supply disruptions risks, especially during crises like COVID-19. Regional suppliers also help in meeting local regulatory labeling and packaging standards.
Technology Integration
Suppliers adopting serialization, anti-counterfeit features, and electronic batch tracking ensure both regulatory compliance and supply integrity for XACDURO.
Sustainability Focus
Increasing pressures for eco-friendly packaging compel suppliers to innovate with biodegradable materials and sustainable manufacturing processes.

Regulatory and Compliance Challenges

Supply chains for co-packaged drugs like XACDURO must navigate complex regulatory landscapes. Suppliers must demonstrate compliance through documentation, audits, and certifications. Mismatched standards can cause delays, product recalls, or legal issues, emphasizing the importance of rigorous qualification protocols.

Conclusion

Sourcing suppliers for XACDURO involves a comprehensive assessment of manufacturing capabilities, regulatory compliance, quality controls, and supply chain resilience. Leading global CMOs such as Catalent, Recipharm, and Patheon serve as primary co-packers, while innovative packaging material suppliers support the process. Strategic diversification, technological adoption, and adherence to regulatory standards are key to establishing a reliable supply chain for co-packaged pharmaceuticals.

Key Takeaways

Identifying compliant, experienced CMOs with specialized co-packaging capabilities is essential for XACDURO’s reliable supply.
Regulatory adherence, quality assurance, and supply chain reliability are the pillars of successful sourcing.
Regional diversification minimizes risks associated with geopolitical, logistical, or health crises.
Incorporating advanced packaging technologies enhances product security and regulatory compliance.
Ongoing innovation and sustainability initiatives are shaping the future of pharmaceutical co-packaging.

FAQs

1. How do I identify the most appropriate supplier for co-packaging XACDURO?
Evaluate potential suppliers based on their regulatory certifications (GMP, ISO), manufacturing capacity, quality control systems, past client references, and technological capabilities in secure packaging.

2. What are the main regulatory considerations when sourcing for XACDURO?
Compliance with regional health authority standards (FDA, EMA, PMDA), verification of validated manufacturing processes, proper labeling, serialization, and packaging integrity are critical.

3. Can regional suppliers adequately meet the demands of global markets for XACDURO?
Yes, if they meet international quality standards and possess robust logistics networks. Regional suppliers can facilitate faster distribution and compliance with local regulations.

4. How important is packaging innovation in the co-packaging of XACDURO?
Crucial. Innovative packaging improves product security, compliance with serialization and anti-counterfeiting measures, and extends shelf life, enhancing patient safety.

5. What risks should be mitigated during the supplier qualification process?
Risks include regulatory non-compliance, quality failures, supply disruptions, and logistical delays. Rigorous audits, validation, and contingency planning are necessary to mitigate these risks.

Sources

[1] Regulatory guidelines for pharmaceutical co-packaging from the FDA and EMA.
[2] Industry reports on top pharmaceutical CMOs and packaging providers.
[3] Company websites and public disclosures of Catalent, Recipharm, and Patheon.
[4] Market analyses on pharmaceutical packaging material suppliers.
[5] Recent industry case studies on supply chain management for co-packaged drugs.

Suppliers and packagers for XACDURO (COPACKAGED)