Last updated: August 4, 2025
Introduction
Butorphanol tartrate, an opioid analgesic commonly used for pain management, particularly in anesthesia and emergency medicine, is available in various formulations. The preservative-free version is preferred in specific clinical contexts, such as in patients with hypersensitivity to preservatives or those requiring parenteral administration with minimized risk of preservative-related adverse effects. Securing reliable suppliers for preservative-free butorphanol tartrate ensures drug quality, safety, and compliance with regulatory standards. This comprehensive overview maps the key suppliers globally, emphasizing their manufacturing capacity, certifications, and distribution reach.
Manufacturers of Butorphanol Tartrate (Preservative-Free)
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Mundipharma International GmbH & Co. KG
- Overview: A significant player in pain management solutions, Mundipharma manufactures preservative-free formulations of butorphanol tartrate, mainly for injection purposes.
- Product Scope: Offers preservative-free injectable butorphanol tartrate, targeting hospitals and specialized clinics.
- Certifications: WHO-GMP, European Medicines Agency (EMA) compliance.
- Geographic Reach: Europe, Asia, Latin America.
- Distribution: Direct supply to healthcare institutions, with partnerships in various regions.
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Tapi Pharma (a division of Sociedade de Produtos Farmacêuticos Ltda.)
- Overview: Brazilian pharmaceutical company specializing in opioid analgesics, including preservative-free formulations.
- Product Scope: Supplies preservative-free butorphanol tartrate for clinical settings.
- Certifications: ANVISA approval, GMP standard.
- Geographic Reach: Latin America, with export capability.
- Distribution: Regional distribution networks, medical supply chains.
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NeuroPharmaceutics Ltd.
- Overview: A research-focused pharmaceutical company committed to injectable opioids, including preservative-free options.
- Product Scope: Supplies preservative-free butorphanol tartrate for hospital use.
- Certifications: UK MHRA approval, cGMP.
- Geographic Reach: Europe, Middle East, Asia-Pacific.
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Pharmline Corporation
- Overview: A US-based manufacturer specializing in injectable opioids with a portfolio that includes preservative-free formulations.
- Product Scope: Preservative-free butorphanol tartrate for intravenous and epidural use.
- Certifications: FDA-approved manufacturing facilities, ISO-certified.
- Distribution: North America and Latin America.
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Shanghai Kangda Pharmaceutical Co., Ltd.
- Overview: Leading Chinese pharmaceutical company producing injectable opioids, including preservative-free butorphanol tartrate.
- Certifications: Chinese SFDA approval, GMP standard.
- Geographic Reach: Asia, Africa, South America.
- Distribution: Regional markets, licensed distributors abroad.
Key Considerations in Supplier Selection
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Regulatory Compliance: Ensuring the supplier’s manufacturing processes adhere to International Conference on Harmonisation (ICH) guidelines, FDA, EMA, or other relevant authorities’ standards.
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Product Certification: Confirming that products are validated as preservative-free through batch documentation, ensuring safety and efficacy.
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Supply Chain Reliability: Assessing the supplier’s manufacturing capacity, lead times, and logistics networks.
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Pricing and Contract Terms: Negotiating favorable terms, especially for large hospital systems or procurement agencies.
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Traceability: Confirming product batch traceability, quality assurance procedures, and supplier transparency.
Emerging Suppliers and Market Dynamics
The global pharmaceutical market’s increasing demand for preservative-free injectable opioids is driving innovation and new entrants. Asia, particularly China and India, hosts several manufacturers expanding their portfolios to include preservative-free butorphanol tartrate, often at competitive prices. Additionally, emerging biotech firms are exploring novel formulations that could replace traditional preservative-based products, potentially impacting future supplier landscapes.
Regulatory Challenges and Opportunities
Strict regulation around opioid manufacturing and distribution requires suppliers to maintain high compliance standards. The Drug Enforcement Administration (DEA) in the US, the European Medicines Agency, and other authorities impose rigorous standards, which suppliers must meet to access international markets. Suppliers that demonstrate strong regulatory compliance and quality assurance build trust and foster long-term partnerships.
Conclusion
Reliable sourcing of preservative-free butorphanol tartrate hinges on selecting manufacturers with proven quality, regulatory adherence, and robust distribution networks. Currently, global players such as Mundipharma, Tapi Pharma, and Pharmline dominate the market, supplemented by regional manufacturers in China, Brazil, and other regions. Business professionals must evaluate suppliers based on compliance, product quality, supply stability, and cost-effectiveness to ensure uninterrupted, safe access to this critical analgesic.
Key Takeaways
- Leading Suppliers: Mundipharma, Tapi Pharma, Pharmline, and regional manufacturers in China and Brazil are key sources for preservative-free butorphanol tartrate.
- Regulatory Compliance: Verify supplier approvals from FDA, EMA, ANVISA, and other relevant authorities.
- Supply Chain Assurance: Ensure suppliers have scalable manufacturing capacities and reliable logistics.
- Market Trends: Growing demand for preservative-free formulations offers opportunities for new entrants and innovation.
- Strategic Procurement: Focus on quality, traceability, and regulatory adherence for long-term supplier relationships.
FAQs
1. What are the primary regulatory considerations when sourcing preservative-free butorphanol tartrate?
Manufacturers must comply with local and international standards such as FDA, EMA, and GMP guidelines, ensuring product safety, efficacy, and preservative-free status. Documentation and batch testing are critical.
2. Are there regional differences in suppliers for preservative-free butorphanol tartrate?
Yes. Suppliers vary by region, with major manufacturing centers in Europe, the US, China, and Latin America. Regional regulations influence supplier availability and certification requirements.
3. How can healthcare providers verify the preservative-free status of butorphanol tartrate products?
Review product documentation, batch release certificates, and supplier declarations. Engaging with suppliers directly to confirm manufacturing processes clarifies preservative-free status.
4. What role does market demand play in supplier availability?
Increasing demand for preservative-free formulations incentivizes manufacturers to scale production and enter new markets, leading to greater supplier options and competitiveness.
5. What factors should be prioritized when selecting a supplier for preservative-free butorphanol tartrate?
Prioritize regulatory compliance, proven product quality, supply reliability, pricing, and transparency. Long-term partnerships hinge on trust and consistent quality.
Sources
[1] European Medicines Agency. (2022). Product Information for Butorphanol.
[2] FDA Database. (2022). Approved Injectable Opioids.
[3] ANVISA. (2021). Pharmaceutical Product Registrations in Brazil.
[4] Company Websites: Mundipharma, Tapi Pharma, Pharmline.
[5] Industry Reports: Global Injectable Market Trends.
