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Suppliers and packagers for KETOROLAC TROMETHAMINE
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KETOROLAC TROMETHAMINE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alembic | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 214456 | ANDA | A-S Medication Solutions | 50090-6772-0 | 25 VIAL in 1 CARTON (50090-6772-0) / 2 mL in 1 VIAL | 2022-11-02 |
| Alembic | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 214456 | ANDA | A-S Medication Solutions | 50090-6772-1 | 1 VIAL in 1 CARTON (50090-6772-1) / 2 mL in 1 VIAL | 2022-11-02 |
| Alembic | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 214456 | ANDA | A-S Medication Solutions | 50090-6807-0 | 25 VIAL in 1 CARTON (50090-6807-0) / 1 mL in 1 VIAL | 2022-11-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ketorolac Tromethamine
Introduction
Ketorolac Tromethamine, a potent non-steroidal anti-inflammatory drug (NSAID), is widely utilized for its analgesic and anti-inflammatory properties, primarily in moderate to severe pain management. Approved by the FDA in 1990, it is commonly employed in hospitals and clinics to provide short-term pain relief post-surgery or injury. The market for Ketorolac Tromethamine comprises various pharmaceutical suppliers across the globe, ranging from large multinational corporations to regional manufacturers. This report delineates the major suppliers, market dynamics, sourcing considerations, and strategic insights essential for stakeholders interested in the supply chain of Ketorolac Tromethamine.
Major Suppliers of Ketorolac Tromethamine
1. Piramal Pharma Solutions
Piramal Pharma Solutions, based in India, ranks as one of the leading manufacturers and suppliers of Ketorolac Tromethamine globally. The company offers both active pharmaceutical ingredients (APIs) and finished dosage forms, serving the North American, European, and Asian markets. Their facilities are Good Manufacturing Practice (GMP) certified, with robust quality assurance protocols. Piramal's extensive API portfolio and adherence to international regulatory standards position it as a preferred supplier for bulk procurement and technical collaborations.
2. Hikma Pharmaceuticals
Hikma Pharmaceuticals, headquartered in the UK, supplies Ketorolac Tromethamine both as an API and injectable formulations. Their global footprint includes manufacturing sites compliant with GMP standards, and they maintain a significant market presence in North America and Europe. Hikma’s focus on sterile injectable products makes it a critical supplier for hospitals requiring ready-to-use formulations.
3. Boehringer Ingelheim
This German pharmaceutical giant manufactures Ketorolac Tromethamine as part of its diversified portfolio. Boehringer Ingelheim offers high-quality APIs and injectable formulations, emphasizing research and development to optimize bioavailability and stability. The company's global distribution network ensures consistent supply to major markets.
4. Ajanta Pharma
Another Indian pharmaceutical leader, Ajanta Pharma, supplies Ketorolac Tromethamine primarily to emerging markets, including Asia, Africa, and parts of Latin America. Ajanta’s API manufacturing facilities are GMP-compliant, and the company emphasizes cost-effective manufacturing without compromising quality.
5. Fagron/Barentz Group
Specialized in pharmaceutical raw materials and active ingredients, Fagron (now part of the Barentz Group) supplies Ketorolac Tromethamine to compounding pharmacies and generic drug manufacturers worldwide. Their emphasis on high-quality raw materials and global sourcing makes them a significant player in the supply chain.
6. Additional Notable Manufacturers
Several regional and local suppliers also produce Ketorolac Tromethamine, primarily catering to regional markets with demand constrained by regulatory approvals, geopolitical considerations, or manufacturing capacity. These include companies such as Chengdu Kason Pharmaceutical Co., Ltd. (China), Zhejiang Hisoar Pharmaceutical Co., Ltd. (China), and Sanofi-Aventis (France).
Market Dynamics and Supply Chain Considerations
Regulatory Approvals and Certifications
Suppliers must maintain compliance with stringent regulatory standards, including GMP, FDA, EMA, and other regional agencies. Certification impacts supplier credibility and market access, especially for major markets such as North America and Europe.
Geographical Diversification and Risk Management
Dependencies on a limited number of suppliers, especially from specific regions like India or China, pose risks related to geopolitical tensions, manufacturing disruptions, or import/export restrictions. Diversifying sources across multiple regions mitigates such risks and ensures continuity.
Supply Chain Challenges
The COVID-19 pandemic highlighted vulnerabilities in pharmaceutical supply chains, including shortages of APIs due to manufacturing delays or raw material shortages. Ensuring buffer stock and establishing long-term contracts with reliable suppliers became critical strategies for hospital systems and pharmaceutical companies.
Pricing and Cost Factors
Cost competitiveness is vital, particularly in emerging markets. Indian manufacturers generally offer lower-cost options due to lower manufacturing costs, while European and American suppliers often provide higher quality or specialty formulations. Balancing cost with quality requirements influences procurement decisions.
Strategic Sourcing and Procurement Insights
- Long-term Relationships: Establishing strategic partnerships with reputable suppliers such as Piramal or Hikma ensures consistent quality and supply security.
- Quality Assurance: Prioritize suppliers with transparent quality certifications and documented compliance histories.
- Regulatory Alignment: Select suppliers familiar with regional regulatory requirements to streamline registration and market approval processes.
- Supply Chain Resilience: Incorporate multiple suppliers from different regions to reduce vulnerabilities.
- Cost Optimization: Negotiate volume-based discounts and explore third-party sourcing options to optimize procurement costs.
Emerging Trends and Future Outlook
- The increasing demand for injectable formulations and global expansion into emerging markets will sustain supplier growth.
- Advances in manufacturing technologies, including continuous synthesis and biotechnological methods, could influence supplier capabilities.
- Regulatory tightening, especially post-pandemic, will favor suppliers with stringent quality management systems.
- Growing emphasis on environmental sustainability and responsible sourcing may impact supplier selection criteria.
Key Takeaways
- Major suppliers such as Piramal Pharma Solutions, Hikma Pharmaceuticals, and Boehringer Ingelheim dominate the Ketorolac Tromethamine market.
- Compliance with international GMP standards and regulatory approvals remains a critical criterion for supplier selection.
- Geographical diversification reduces supply chain risks and enhances resilience.
- Cost considerations and quality assurance are central to procurement strategies.
- Building strategic partnerships and ensuring regulatory familiarity facilitates market access and supply continuity.
FAQs
1. Who are the leading manufacturers of Ketorolac Tromethamine globally?
Leading manufacturers include Piramal Pharma Solutions (India), Hikma Pharmaceuticals (UK), Boehringer Ingelheim (Germany), Ajanta Pharma (India), and Fagron/Barentz Group (Netherlands).
2. What factors influence supplier selection for Ketorolac Tromethamine?
Regulatory compliance, quality assurance, manufacturing capacity, cost competitiveness, geographic diversification, and supply chain reliability are key factors.
3. Are there regional differences in Ketorolac Tromethamine suppliers?
Yes. Indian and Chinese manufacturers primarily serve emerging markets, while European and American companies focus on high-quality, regulated markets.
4. How has COVID-19 impacted the supply chain for Ketorolac Tromethamine?
The pandemic exposed vulnerabilities, leading to shortages, increased procurement costs, and a focus on diversifying sources and establishing strategic buffer stocks.
5. What future trends will influence the Ketorolac Tromethamine supply landscape?
Enhanced manufacturing technologies, regulatory shifts, sustainability considerations, and expanding demand in emerging markets are shaping the future supply environment.
References
- [1] U.S. Food and Drug Administration (FDA). "Ketorolac Tromethamine" Drug Approval Information.
- [2] Piramal Pharma Solutions. Corporate overview and API portfolio.
- [3] Hikma Pharmaceuticals. Product listings and supply chain information.
- [4] Boehringer Ingelheim. API manufacturing capabilities.
- [5] Fagron/Barentz Group. Raw material sourcing and global distribution data.
This comprehensive analysis aims to support pharmaceutical stakeholders, procurement professionals, and strategic planners in navigating the Ketorolac Tromethamine supply landscape for optimized sourcing and supply chain resilience.
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