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Suppliers and packagers for xylocaine
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xylocaine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | XYLOCAINE | lidocaine hydrochloride | INJECTABLE;INJECTION | 006488 | NDA | Henry Schein, Inc. | 0404-9972-20 | 1 VIAL in 1 BAG (0404-9972-20) / 20 mL in 1 VIAL | 2022-01-10 |
| Fresenius Kabi Usa | XYLOCAINE | lidocaine hydrochloride | INJECTABLE;INJECTION | 006488 | NDA | Henry Schein, Inc. | 0404-9973-20 | 1 VIAL in 1 BAG (0404-9973-20) / 20 mL in 1 VIAL | 2022-01-10 |
| Fresenius Kabi Usa | XYLOCAINE | lidocaine hydrochloride | INJECTABLE;INJECTION | 006488 | NDA | Henry Schein, Inc. | 0404-9973-50 | 1 VIAL in 1 BAG (0404-9973-50) / 50 mL in 1 VIAL | 2022-01-10 |
| Fresenius Kabi Usa | XYLOCAINE | lidocaine hydrochloride | INJECTABLE;INJECTION | 006488 | NDA | Henry Schein, Inc. | 0404-9974-20 | 1 VIAL in 1 BAG (0404-9974-20) / 20 mL in 1 VIAL | 2022-01-17 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: XYLOCAINE
Introduction
Xylocaine, known generically as lidocaine, is a widely used local anesthetic essential in various medical and dental procedures. As demand for effective anesthesia grows, the global supply chain for lidocaine faces increasing scrutiny and strategic importance. This article provides a comprehensive overview of primary suppliers involved in the manufacturing and distribution of Xylocaine, examining global manufacturing hubs, key industry players, raw material sourcing, and market trends impacting supply dynamics.
Overview of Xylocaine (Lidocaine) Manufacturing
Lidocaine is synthesized through chemical processes involving specific intermediates, primarily derived from benzene derivatives. Its production requires high-quality raw materials and adherence to stringent regulatory standards to ensure safety and efficacy. Leading pharmaceutical companies either manufacture the drug locally or offshore and distribute it globally. The supply chain encompasses raw material suppliers, contract manufacturing organizations, and distribution networks within both branded and generic markets.
Major Suppliers of Xylocaine
1. Novartis and its Historical Role
Novartis historically marketed Xylocaine as a branded product but has since divested many assets in favor of generic formulations. Still, the company's legacy manufacturing facilities and supply chain structures influence the market dynamics, especially in Europe and North America.
2. Mylan / Viatris
Viatris (formerly Mylan) is a major global player in generic pharmaceuticals, including lidocaine injections. Its extensive manufacturing network spans North America, India, and Europe. Viatris is known for its cost-effective production processes and broad distribution channels, making it a key supplier especially for institutional and hospital use.
3. Hikma Pharmaceuticals
Hikma, headquartered in Jordan, is a leading manufacturer of injectable drugs, including lidocaine. The company has developed a robust manufacturing infrastructure in the Middle East and Europe, supplying both regional and international markets.
4. Hospira (A Pfizer Company)
Hospira remains a significant supplier of injectable medications, including lidocaine, especially for North American and European markets. Pfizer’s acquisition of Hospira reinforced its position in sterile injectable drugs.
5. Teva Pharmaceutical Industries
Teva is one of the world’s largest generic drug manufacturers, producing lidocaine in various formulations. Its manufacturing plants in Israel, India, and the United States serve as critical nodes in global supply chains.
6. Local and Regional Manufacturers
Beyond global giants, multiple regional manufacturers supply lidocaine, such as:
- Stellus Pharma (India): A key exporter of injectable anesthetics, including lidocaine.
- Baxter International: Supplies lidocaine formulations especially for North American markets.
- Lupin Limited: Indian pharmaceutical company with active lidocaine production.
Raw Material Suppliers and Supply Chain Considerations
Lidocaine synthesis depends heavily on benzene derivatives and other chemical intermediates. Raw material suppliers are often located in major chemical-producing countries such as China, India, and Germany.
- China’s Role: China is a significant supplier of bulk chemicals essential for lidocaine synthesis, given its cost advantages and extensive chemical manufacturing infrastructure.
- India and Southeast Asia: These regions are pivotal in the formulation of generic injectable medicines, providing both raw chemicals and finished products on a large scale.
- European Suppliers: High standards and stringent quality requirements mean European suppliers often serve as sources for high-purity intermediates, especially for branded products.
Supply chain disruptions in raw material sourcing—due to geopolitical tensions, trade restrictions, or pandemic-related issues—can impact manufacturing timelines.
Market Dynamics and Supply Risks
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Regulatory Environment
Manufacturers must comply with strict regulatory standards, notably the FDA (U.S.), EMA (Europe), and other national agencies. Certification processes, Good Manufacturing Practices (GMP), and quality assurance affect both supply stability and the capacity to scale production. -
Patent Expiry and Generic Competition
Once patents for original products like Xylocaine expired, generic manufacturers surged, increasing supply but also intensifying market competition. This has led to pressure on pricing and potential shifts in supply chain priorities. -
Manufacturing Capacity Constraints
Increased demand for anesthetics amid global healthcare expansions has occasionally strained manufacturing capacities. The COVID-19 pandemic further highlighted vulnerabilities in global supply chains for active pharmaceutical ingredients (APIs). -
Regional Supply Disruptions
Political instability, natural disasters, or trade barriers, particularly in key supplier regions like China and India, threaten supply continuity.
Emerging Trends Influencing Xylocaine Supply
- Shift Toward Localized Production: Countries with large healthcare markets are incentivizing domestic manufacturing of active pharmaceutical ingredients (APIs) to reduce dependency on cross-border supply.
- Strategic Stockpiling: Healthcare providers and governments are stockpiling essential anesthetic supplies to mitigate supply chain disruptions.
- Innovations in Manufacturing: Continuous process improvements and biotechnological advances aim to enhance yield, reduce costs, and strengthen supply resilience.
- Environmental and Sustainability Standards: Increasing pressure for greener manufacturing practices may influence supplier choices and regulatory approval timelines.
Conclusion
The global supply of Xylocaine (lidocaine) hinges on a complex network of multinational corporations, regional manufacturers, and raw material providers. Major pharmaceutical companies like Viatris, Hikma, Hospira, and Teva dominate the manufacturing landscape, supported by raw material suppliers primarily based in Asia and Europe. Supply stability is increasingly influenced by geopolitical, regulatory, and environmental factors, demanding strategic foresight from stakeholders across the healthcare ecosystem. Ensuring a resilient supply chain for lidocaine remains crucial as global demand for anesthetic agents continues to grow, driven by expanding healthcare access and procedural volumes worldwide.
Key Takeaways
- Leading manufacturers such as Viatris, Hikma, Hospira, and Teva dominate the global lidocaine market.
- Raw material sourcing from China and India is vital, but geopolitical and trade issues pose risks.
- Regulatory standards significantly influence manufacturing capacity and supply continuity.
- The push for localized production and stockpiling aims to mitigate supply chain vulnerabilities.
- Technological and environmental innovations are shaping future manufacturing and supply strategies.
Frequently Asked Questions
1. Who are the primary global suppliers of Xylocaine (lidocaine)?
Major suppliers include Viatris, Hikma Pharmaceuticals, Hospira (Pfizer), and Teva Pharmaceutical Industries, supported by regional manufacturers such as Stellus Pharma and Lupin.
2. What challenges does the supply chain for lidocaine face?
Challenges include raw material sourcing disruptions, regulatory compliance, manufacturing capacity constraints, geopolitical tensions, and recent global health crises impacting logistics.
3. How do raw material suppliers influence the availability of lidocaine?
Raw material quality, cost, and geopolitical stability in supplier regions directly affect production timelines and cost efficiency, ultimately impacting supply.
4. Are there regional differences in lidocaine manufacturing?
Yes. While the U.S. and Europe host high-regulatory-compliance manufacturers like Hospira, Asia—particularly India and China—serves as a significant base for volume production and raw materials.
5. What emerging trends could impact future lidocaine supply?
Increased local manufacturing, strategic stockpiling, technological innovations, and sustainability efforts are shaping the future landscape of lidocaine supply stability.
References
[1] Global pharmaceutical manufacturing data, IQVIA, 2022.
[2] Market analysis reports on injectable anesthetics, IQVIA, 2023.
[3] Regulatory standards for sterile injectables, FDA, EMA guidelines.
[4] Major pharmaceutical company annual reports, 2022–2023.
[5] Chemical industry reports on raw material sourcing, S&P Global Platts, 2022.
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