Suppliers and packagers for COMBOGESIC IV

COMBOGESIC IV

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320	NDA	Hikma Pharmaceuticals USA Inc.	0143-9150-10	10 VIAL in 1 CARTON (0143-9150-10) / 100 mL in 1 VIAL (0143-9150-01)	2024-02-05

Last updated: July 30, 2025

ppliers for the Pharmaceutical Drug: COMBOGESIC IV

Introduction

COMBOGESIC IV is a combination medication primarily used for analgesia, combining opioid and non-opioid components to provide effective pain management. Its formulation typically includes active ingredients such as paracetamol (acetaminophen) and an opioid analgesic like tramadol, aiming to deliver synergistic pain relief while reducing individual drug side effects. As a specialized pharmaceutical product, the supply chain for COMBOGESIC IV involves various manufacturers and distributors, often governed by regional regulatory frameworks. Understanding the landscape of suppliers is crucial for stakeholders seeking consistent supply, regulatory compliance, and strategic procurement.

Manufacturers of COMBOGESIC IV

The primary manufacturers of COMBOGESIC IV are pharmaceutical corporations that focus on both active pharmaceutical ingredients (APIs) and finished dosage forms. These companies operate within stringent quality standards, including Good Manufacturing Practices (GMP), to ensure product safety, efficacy, and consistency.

1. Sun Pharmaceutical Industries Ltd.

A leading global pharmaceutical company based in India, Sun Pharma produces a wide array of generic and branded medications. It supplies COMBOGESIC IV under its intravenous and combination drug portfolios, leveraging extensive manufacturing capabilities. The company maintains a robust quality assurance system to meet international regulatory standards, facilitating exports to markets such as North America, Europe, and Asia.

2. Mylan N.V. (now part of Viatris)

Viatris, formed from the merger of Mylan and Pfizer’s Upjohn unit, has a significant presence in injectable and pain management products worldwide. While its portfolio predominantly includes generic formulations, it manufactures combination products similar to COMBOGESIC IV, emphasizing cost-effective supply chains and compliance with global standards.

3. Hospira (a Pfizer division)

Hospital and clinical formulations, including intravenous analgesics, are within Hospira’s expertise. Its manufacturing facilities in the United States and Europe are certified under GMP, supplying sterile injectable combinations comparable to COMBOGESIC IV. Hospira’s strategic focus on sterile and injectable drugs makes it a notable supplier in the IV analgesic segment.

4. Teva Pharmaceutical Industries Ltd.

As a major player in generic pharmaceuticals, Teva produces intravenous pain medications, encompassing combination therapies. With manufacturing sites holding multiple international certifications, Teva serves markets in North America, Europe, and emerging regions, ensuring a reliable source of IV medications.

Regional Suppliers and Market Variability

Beyond multinational corporations, regional pharmaceutical companies supply COMBOGESIC IV or equivalent formulations tailored to local regulatory and clinical needs. For instance:

• India: Multiple local manufacturers produce generic versions of COMBOGESIC IV, given India’s large pharmaceutical industry meeting WHO-GMP standards. These include companies such as Granules India and Aurobindo Pharma, which manufacture sterile injectable combination drugs for domestic use and export.

• Latin America and Southeast Asia: Local entrepreneurs and regional giants supply standardized formulations, often under licensing agreements with global firms or through generic manufacturing in compliance with regional regulations.

Supply Chain Considerations

The procurement of COMBOGESIC IV is often influenced by regulatory approvals, patent statuses, and regional drug registration. Many suppliers operate within the framework of manufacturing licenses, ensuring their products meet the stipulated bioequivalence and safety standards. Additionally, supply chain robustness can be affected by geopolitical issues, manufacturing disruptions, and global health crises, such as the COVID-19 pandemic, underscoring the importance of diversified sourcing strategies.

Regulatory and Quality Assurance

Suppliers must comply with regional and international quality standards, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. WHO prequalification status often enhances supplier credibility in emerging markets, promoting confidence among healthcare providers and procurement agencies.

Partnerships and Licensing Agreements

Manufacturers may establish licensing or partnership agreements to produce COMBOGESIC IV in various jurisdictions, expanding supply chains and mitigating risks associated with sole sourcing. Such collaborations also enable rapid scaling in response to demand surges, pivotal during health emergencies.

Market Outlook and Future Suppliers

As demand for IV analgesics grows, especially in chronic pain management and post-surgical care, manufacturers are expanding production capacities. Technological advancements, such as bioavailability improvements and novel delivery systems, are influencing supplier landscapes. Emerging regional players in Asia and Eastern Europe are increasingly investing in GMP-compliant facilities to capitalize on global markets.

Key Considerations for Stakeholders

• Regulatory Approvals: Confirm supplier registration and approval status in relevant markets.
• Quality Certifications: Prioritize suppliers with GMP, FDA, EMA, or equivalent certifications.
• Supply Chain Diversification: To prevent disruptions, source from multiple approved suppliers.
• Pricing and Contracting: Negotiate favorable terms while ensuring compliance and supply security.
• Monitoring and Compliance: Regularly audit supplier compliance with evolving international standards.

Conclusion

The supply of COMBOGESIC IV is anchored by a network of global and regional manufacturers committed to adhering to rigorous quality and safety standards. Key players include Sun Pharma, Viatris, Hospira, and Teva, among others, with regional suppliers complementing the international supply chain. Ensuring procurement from reliable, compliant, and diversified sources is vital for healthcare providers aiming to deliver consistent pain management therapies. As market dynamics evolve, suppliers' technological capabilities, regulatory standing, and geopolitical resilience will continue to shape the availability and affordability of COMBOGESIC IV worldwide.

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Key Takeaways

• Leading global manufacturers of COMBOGESIC IV include Sun Pharma, Viatris, Hospira, and Teva, all maintaining GMP-certified production for international markets.
• Regional suppliers—particularly in India and emerging markets—play a crucial role in ensuring local availability through generic manufacturing.
• Regulatory compliance and quality certifications are critical for supplier credibility and product safety assurance.
• Supply chain diversification and regular vendor compliance monitoring mitigate risks associated with disruptions and geopolitical challenges.
• Innovations and regional manufacturing capacity expansion will influence future supply stability and pricing dynamics.

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FAQs

1. Is COMBOGESIC IV available from multiple suppliers globally?
Yes, COMBOGESIC IV or equivalent formulations are produced by several global manufacturers, including Sun Pharma, Viatris, Hospira, and Teva, ensuring competitive supply in international markets.

2. How can procurement agencies verify supplier compliance?
Procurement agencies should verify suppliers’ GMP certifications, registration with relevant regulatory authorities (FDA, EMA, etc.), and adherence to international manufacturing standards through official documentation and audits.

3. Are regional manufacturers reliable sources for COMBOGESIC IV?
Regional manufacturers, particularly in India and Southeast Asia, can be reliable if they meet international GMP standards and possess necessary regulatory approvals. Selecting suppliers with established compliance histories is essential.

4. What are the risks associated with sourcing COMBOGESIC IV?
Risks include supply chain disruptions, regulatory non-compliance, pricing volatility, and geopolitical issues affecting manufacturing or export capabilities. Diversifying suppliers mitigates these risks.

5. How is the future landscape of COMBOGESIC IV suppliers expected to evolve?
An increase in regional manufacturing capacity, technological innovations in formulations, and stricter regulatory standards are likely to diversify and stabilize the supplier landscape over the coming years.

Sources
[1] U.S. Food and Drug Administration (FDA). Pharmaceutical Manufacturing Standards. 2022.
[2] European Medicines Agency (EMA). Good Manufacturing Practice Guidelines. 2022.
[3] Sun Pharmaceutical Industries Ltd. Annual Report 2022.
[4] Viatris Corporate Website. Product Portfolio. 2023.
[5] Hospira Product Line Overview. 2022.