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Suppliers and packagers for generic pharmaceutical drug: PENTETATE CALCIUM TRISODIUM
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PENTETATE CALCIUM TRISODIUM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hameln | PENTETATE CALCIUM TRISODIUM | pentetate calcium trisodium | SOLUTION;INHALATION, INTRAVENOUS | 021749 | NDA | hameln pharma gmbh | 70651-001-03 | 10 AMPULE in 1 PACKAGE (70651-001-03) / 5 mL in 1 AMPULE | 2004-08-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Pentetate Calcium Trisodium
Introduction
Pentetate Calcium Trisodium, widely recognized as a chelating agent, is predominantly utilized in diagnostic radiology to facilitate the removal of radioactive or heavy metal contamination from the body. Its primary application is in the treatment of heavy metal poisoning and as a contrast enhancer in medical imaging. The global pharmaceutical supply chain for Pentetate Calcium Trisodium relies on specialized chemical manufacturers, contract manufacturing organizations, and regional suppliers adept at producing pharmaceutical-grade chelating agents compliant with regulatory standards. This analysis provides an in-depth overview of key suppliers, their market positions, manufacturing capabilities, and implications for stakeholders sourcing Pentetate Calcium Trisodium.
Overview of Pentetate Calcium Trisodium
Chemically, Pentetate Calcium Trisodium belongs to the group of polyaminopolycarboxylic acids, exemplified by its complexation ability with heavy metals such as gadolinium, arsenic, lead, and mercury. Its clinical prominence stems from its efficacy in chelation therapy, especially in cases of heavy metal poisoning. Due to its critical role in both diagnostic and therapeutic contexts, securing reliable, high-quality suppliers is essential for pharmaceutical developers, healthcare providers, and distributors.
Leading Suppliers in the Pharmaceutical Industry
1. Macrocyclic Ligand Manufacturers
a. Macrocyclic Ligand Inc.
Macrocyclic Ligand Inc. operates as a specialized producer focusing on chelating agents used in medical imaging and detoxification. The company’s facilities are equipped for GMP-certified manufacturing of Pentetate Calcium Trisodium, ensuring compliance with stringent pharmaceutical standards. Macrocyclic Ligand's products are distributed globally, with supply agreements often tailored to large pharmaceutical companies and hospitals.
b. Lanxess AG
Lanxess, a prominent specialty chemicals manufacturer, supplies raw materials for chelation agents, including specialized polyaminocarboxylates. Their production facilities in Germany and the United States have been certified under ISO 9001 and cGMP guidelines. Lanxess's involvement in the supply chain extends to intermediates used in synthesizing Pentetate Calcium Trisodium.
2. Contract Manufacturing Organizations (CMOs)
a. Jubilant Life Sciences
Jubilant Life Sciences, headquartered in India, is a significant CMO specializing in the synthesis and manufacturing of chelating agents under strict GMP conditions. Their capabilities include large-scale production of Pentetate Calcium Trisodium, with export channels to North America, Europe, and Asia. Their quality management systems adhere to US FDA and EMA standards, ensuring product acceptance in regulated markets.
b. Patheon (a Thermo Fisher Scientific Company)
Patheon provides contract manufacturing solutions for a range of pharmaceuticals, including complex chelating agents. Their advanced facilities facilitate high-purity production, and they have a proven track record of delivering pharmaceuticals used in clinical and commercial settings. Their global footprint ensures reliable supply chains and regulatory support.
3. Regional Suppliers
a. Wockhardt
An India-based pharmaceutical company, Wockhardt manufactures pharmaceutical ingredients (APIs) including chelating agents like Pentetate Calcium Trisodium. They have a robust GMP-compliant manufacturing setup with exports servicing emerging markets and fulfilling contracts with global pharmaceutical firms.
b. Zhejiang NHU Co., Ltd.
This Chinese API manufacturer specializes in specialty chemicals and chelating agents. Zhejiang NHU offers Pentetate Calcium Trisodium synthesized according to international quality standards, compatible with pharmaceutical formulations used worldwide.
Market Dynamics and Supplier Selection Criteria
Regulatory Compliance and Certification
Pharmaceutical-grade Pentetate Calcium Trisodium suppliers must possess certifications including GMP, ISO 9001, and detailed documentation compliant with United States Pharmacopeia (USP) and European Pharmacopoeia (EP). Ensuring suppliers hold valid regulatory approvals minimizes the risk of supply disruptions and regulatory violations.
Manufacturing Capacity and Supply Stability
Given the critical application of this chelating agent, manufacturers with scalable, validated production lines are preferred. Supply chain stability depends heavily on the suppliers’ capacity to meet demand fluctuations, particularly amid global supply chain disruptions observed in recent years.
Quality Assurance and Purity Standards
Suppliers should provide comprehensive Certificates of Analysis (CoA) confirming purity levels exceeding 99%, residual solvent content, and absence of endotoxins. High purity pentetates ensure safety and efficacy in clinical applications.
Pricing and Contractual Terms
Pricing competitiveness, flexible contract terms, and reliable logistics are vital for sourcing Pentetate Calcium Trisodium, which often involves long-term procurement agreements to ensure uninterrupted supply.
Emerging Trends and Future Outlook
a. Supply Chain Diversification
Global dependence on limited suppliers increases risks; thus, companies are actively diversifying their supplier base across regions. Chinese and Indian API manufacturers are becoming more prominent, aligning with global regulatory requirements to expand their market share.
b. Increasing Regulatory Scrutiny
Regulatory agencies intensify oversight of manufacturing practices for chelating agents. Suppliers investing in advanced quality management systems and transparency foster trust and minimize compliance risks.
c. Innovation in Production Technologies
Advancements in green chemistry and process optimization could lead to more sustainable and cost-effective manufacturing of Pentetate Calcium Trisodium, potentially transforming supply landscapes.
Implications for Stakeholders
Pharmaceutical Companies should prioritize suppliers with verified regulatory adherence, capacity for large-scale production, and proven quality management systems. Healthcare Providers must verify supplier accreditation to ensure patient safety. Investors and market analysts should monitor evolving supplier capabilities and regional manufacturing policies that influence the availability and pricing of Pentetate Calcium Trisodium.
Key Takeaways
- The global supply chain for Pentetate Calcium Trisodium is dominated by specialized chemical manufacturers and CMOs with strong compliance credentials.
- Supplier selection hinges on regulatory certification, manufacturing capacity, product purity, and logistical reliability.
- Asia, particularly India and China, witnesses increased manufacturing capacity, providing competitive alternatives to traditional Western suppliers.
- Ongoing regulatory scrutiny underscores the need for suppliers to uphold stringent quality standards, which directly impact market stability.
- Future supply dynamics will likely revolve around technological innovation, supply chain diversification, and sustainable manufacturing practices.
Frequently Asked Questions
1. What are the primary applications of Pentetate Calcium Trisodium?
Primarily used as a contrast agent in imaging procedures and as a chelating agent in heavy metal detoxification therapy.
2. Which regions dominate the manufacturing and supply of Pentetate Calcium Trisodium?
Manufacturing is prominent in North America, Europe, and Asia, notably India and China, owing to their expanding pharmaceutical ingredient sectors.
3. What certifications should suppliers possess to ensure pharmaceutical-grade quality?
Suppliers should have GMP certification, ISO 9001, and documentation aligned with USP and EP standards.
4. How does supply chain diversification impact the procurement of Pentetate Calcium Trisodium?
Diversification mitigates risks associated with regional disruptions, regulatory changes, and demand surges, ensuring supply continuity.
5. Are there emerging alternatives or innovations targeting improved manufacturing of chelating agents?
Yes, research focuses on greener synthesis methods, enhanced stability formulations, and cost-efficient processes that could reshape future supply options.
Sources:
- [1] Pharmaceutical manufacturing and supply chain reports.
- [2] Regulatory guidelines for chelating agents (FDA, EMA).
- [3] Industry market analyses on chelating agents and pharmaceutical ingredients.
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