Last updated: August 13, 2025
Introduction
ANEXSIA 7.5/325 is a proprietary medication, commonly prescribed as a combination analgesic comprising 7.5 mg of tramadol and 325 mg of acetaminophen (paracetamol). Known for its efficacy in moderate to severe pain management, it is a commercially valuable pharmaceutical product with a complex supply chain involving various manufacturers, raw material suppliers, and distributors. Understanding the procurement landscape for ANEXSIA 7.5/325 is critical for healthcare providers, pharmaceutical companies, and regulatory agencies to ensure a steady supply, compliance, and quality assurance.
Market Overview
The global demand for combination analgesics like ANEXSIA 7.5/325 continues to grow, driven by increasing chronic pain cases and postoperative pain management needs. The production and supply chain are characterized by consolidations among major pharmaceutical manufacturers, regional disparities in manufacturing capacity, and stringent regulatory standards governing raw material sourcing and Good Manufacturing Practices (GMP).
Key Manufacturers of ANEXSIA 7.5/325
While ANEXSIA 7.5/325 is often produced by regional pharmaceutical companies under licensing agreements, several global and regional manufacturers are known to produce generic or equivalent formulations subject to regulatory approvals.
1. Major Global Pharmaceutical Companies
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Qualitest Pharmaceuticals: Known for manufacturing generic analgesics, including tramadol and acetaminophen combination formulations. They possess extensive manufacturing facilities adhering to GMP standards and supply to North America and Europe.
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Mylan (now part of Viatris): A key player in generic pharmaceuticals, with extensive product lines involving tramadol-acetaminophen combinations. Their manufacturing plants in the US and Europe are compliant with international standards.
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Sandoz (Novartis): Produces generic formulations and has broad distribution channels worldwide, including tramadol-based analgesics.
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Teva Pharmaceuticals: A global leader in generics, with manufacturing capabilities for similar combination drugs, including tramadol and acetaminophen formulations.
2. Regional and Local Manufacturers
In addition to multinational corporations, regional pharma companies often supply local markets with licensed or generic versions. Their sources include:
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Indian Pharmaceutical Manufacturers: Companies like Sun Pharmaceutical Industries, Piramal Enterprises, and Dr. Reddy's Laboratories frequently produce tramadol/acetaminophen combinations, adhering to local regulatory standards, and often export to international markets.
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Chinese Pharmaceutical Companies: Several Chinese firms manufacture APIs (Active Pharmaceutical Ingredients) and finished dosage forms for domestic and export purposes, including tramadol and acetaminophen.
Raw Material Suppliers
The quality and consistency of ANEXSIA's active ingredients hinge on the suppliers of tramadol HCl and acetaminophen API.
Tramadol API Suppliers
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WeiHai HaiPai Pharmaceutical Co., Ltd. (China): A major producer of tramadol HCl API, with GMP-certified facilities serving international markets.
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Shandong Xinhua Pharmaceutical Company Limited (China): Supplies tramadol API with certification for global distribution.
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Sun Pharmaceutical Industries (India): Manufactures tramadol API for internal use and export, with strict quality controls.
Acetaminophen API Suppliers
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Hubei Hongyan Pharmaceutical Co., Ltd. (China): Supplies high-quality acetaminophen API globally.
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Johnson Matthey PLC (UK): Provides acetaminophen for pharmaceutical manufacturing, adhering to high standards.
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Lanxess AG (Germany): Supplies purified APIs suitable for analgesic formulations.
Distribution Channel and Logistics
Once manufactured, ANEXSIA 7.5/325 is distributed via authorized wholesalers, pharmacy chains, and healthcare distributors. The supply chain often involves:
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Pharmaceutical Wholesalers: Ensuring wholesale procurement and logistics to pharmacies and hospitals.
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Regulatory Agencies: Overseeing import/export compliance, quality standards, and licensing.
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Regional Distributors: Handling transportation, storage, and delivery within specific countries.
Regulatory Considerations and Certification
Suppliers and manufacturers must comply with regulatory standards such as:
- FDA (Food and Drug Administration, USA)
- EMA (European Medicines Agency)
- PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
- Local regulatory bodies in various countries.
Certifications like GMP, ISO 9001, and API-specific certifications underpin supplier credibility.
Challenges and Opportunities
Supply Chain Disruptions: Geopolitical tensions, COVID-19 pandemic, and raw material shortages have intermittently strained supply chains.
Quality Assurance: Counterfeit drugs and substandard APIs pose risks; hence, sourcing from certified suppliers is crucial.
Emerging Markets: Growing demand in emerging markets offers opportunities for regional suppliers.
Sustainability and Regulatory Changes: Increasing regulation on opioids like tramadol necessitates rigorous compliance and traceability.
Conclusion
The supply chain for ANEXSIA 7.5/325 involves a mix of multinational pharmaceutical giants, regional manufacturers, and raw material suppliers predominantly based in Asia and Europe. Ensuring a reliable supply demands vigilance over quality, regulatory compliance, and logistical efficiency. Stakeholders should prioritize sourcing from GMP-certified suppliers of APIs such as tramadol and acetaminophen, to mitigate risks associated with product quality and supply interruptions.
Key Takeaways
- The primary suppliers for ANEXSIA 7.5/325 include global players like Mylan, Teva, and Sandoz, complemented by regional manufacturers in India and China.
- Raw material sourcing, especially tramadol and acetaminophen APIs, hinges on compliance with international quality standards from certified suppliers.
- Supply chain stability is increasingly challenged by geopolitical and pandemic-related disruptions, underscoring the need for diversified sourcing strategies.
- Regulatory compliance and quality assurance remain critical, with certifications such as GMP and ISO serving as vital indicators of supplier credibility.
- Emerging markets offer growth opportunities, but also require adherence to local regulatory and importation standards.
FAQs
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Who are the leading global manufacturers of ANEXSIA 7.5/325?
Major international companies like Mylan (Viatris), Teva, Sandoz, and Qualitest Pharmaceuticals produce generic versions and may supply licensed ANEXSIA formulations.
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What are the primary raw material suppliers for tramadol and acetaminophen APIs?
Prominent suppliers include Chinese firms such as WeiHai HaiPai Pharmaceutical and Shandong Xinhua Pharmaceutical, alongside European companies like Lanxess.
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How does regulatory compliance influence supplier selection?
Suppliers with GMP, ISO, and API-specific certifications ensure product quality, legal compliance, and reduce regulatory risks.
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What challenges are faced in sourcing for ANEXSIA 7.5/325?
Supply disruptions due to geopolitical factors, raw material shortages, and stringent opioid regulations can impact availability and pricing.
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Are regional manufacturers a reliable source for ANEXSIA 7.5/325?
Yes, provided they adhere to international quality standards and possess appropriate regulatory certifications, regional manufacturers can effectively supply local markets.
Sources
[1] US Food and Drug Administration (FDA). Pharmaceutical Quality Resources.
[2] European Medicines Agency (EMA). Medicines Manufacturers and Suppliers Database.
[3] Indian Pharmaceutical Industry Reports.
[4] Chinese API Manufacturers Directory.
[5] Industry Market Reports on Analgesic Pharmaceuticals.
