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Suppliers and packagers for generic pharmaceutical drug: LITHIUM CITRATE
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LITHIUM CITRATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Rubicon Research | LITHIUM CITRATE | lithium citrate | SYRUP;ORAL | 218036 | ANDA | Precision Dose, Inc. | 68094-077-62 | 3 TRAY in 1 CASE (68094-077-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-077-59) | 2025-10-24 |
| Rubicon Research | LITHIUM CITRATE | lithium citrate | SYRUP;ORAL | 218036 | ANDA | REMEDYREPACK INC. | 70518-4227-0 | 10 CUP in 1 BOX (70518-4227-0) / 5 mL in 1 CUP (70518-4227-1) | 2024-11-04 |
| Rubicon Research | LITHIUM CITRATE | lithium citrate | SYRUP;ORAL | 218036 | ANDA | REMEDYREPACK INC. | 70518-4227-2 | 10 CUP, UNIT-DOSE in 1 BOX (70518-4227-2) / 10 mL in 1 CUP, UNIT-DOSE (70518-4227-3) | 2024-11-04 |
| Rubicon Research | LITHIUM CITRATE | lithium citrate | SYRUP;ORAL | 218036 | ANDA | Advagen Pharma Ltd | 72888-172-46 | 500 mL in 1 BOTTLE (72888-172-46) | 2022-11-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Lithium Citrate
Introduction
Lithium citrate, a lithium salt of citric acid, serves as a key pharmaceutical compound primarily used in the treatment of bipolar disorder and other mood stabilization therapies. As a critical API (Active Pharmaceutical Ingredient), its supply chain is vital for pharmaceutical manufacturers. Reliable sourcing from established suppliers ensures drug quality, regulatory compliance, and uninterrupted production. This report provides an in-depth analysis of leading suppliers for lithium citrate, examining manufacturing capacity, geographic distribution, regulatory adherence, and market trends.
Global Supply Landscape of Lithium Citrate
The global lithium citrate market is governed by a limited number of specialized chemical manufacturers due to the compound’s complex synthesis, strict quality standards, and regulatory hurdles inherent in pharmaceutical APIs. Predominantly, suppliers are based in regions with robust chemical manufacturing infrastructure, especially Asia, Europe, and North America.
Major Suppliers of Lithium Citrate
1. Johnson Matthey
Overview: Johnson Matthey, a UK-based specialty chemicals and catalysis company, is recognized for its high-purity pharmaceutical-grade chemicals, including lithium compounds. Their extensive R&D capabilities enable them to produce lithium citrate conforming to pharmacopeial standards, such as USP and EP.
Capabilities & Compliance: Johnson Matthey supplies lithium citrate in various grades, including pharmaceutical and research grades. Their manufacturing adheres to cGMP (current Good Manufacturing Practices) and ISO standards, ensuring regulatory compliance internationally.
Market Position: As a long-established leader, Johnson Matthey’s products are preferred by multinational pharmaceutical firms for quality and supply reliability.
2. Sigma-Aldrich (Merck KGaA)
Overview: Sigma-Aldrich, now part of Merck KGaA, is a prominent supplier of specialty chemicals and APIs to laboratories and pharmaceutical companies worldwide.
Product Range & Quality: They distribute lithium citrate of high purity suitable for research and formulation purposes. Their scale of operation allows for flexible supply options, and their rigorous quality assurance processes meet regulatory standards globally.
Regulatory and Distribution: Sigma-Aldrich’s extensive distribution network provides timely delivery, crucial for manufacturing continuity.
3. Tianjin Ruijiang Pharmaceutical Co., Ltd.
Overview: A China-based manufacturer specializing in lithium salts, including lithium citrate and lithium carbonate, with a focus on pharmaceutical-grade products.
Manufacturing Strengths: They possess advanced synthesis and purification technology, yielding high-purity lithium citrate compliant with international pharmacopoeias.
Market Dynamics: As a competitive Asian supplier, Tianjin Riguang offers cost-effective sourcing options, with increasing recognition across global markets.
4. Shanxi Zhenhua Chemical Industry Co., Ltd.
Overview: Based in China, Zhenhua supplies lithium citrate primarily for industrial and pharmaceutical applications.
Regulatory footprint: Their manufacturing facilities are certified to ISO standards, and their products are exported to Europe, North America, and other regions, subject to regulatory approvals.
5. CIM International
Overview: A specialty chemical producer located in India, CIM International offers lithium citrate and other lithium salts tailored for pharmaceutical formulators.
Quality & Service: The company emphasizes quality control and compliance with international regulations, catering to the growing South Asian pharmaceutical sector.
Emerging and Niche Suppliers
In addition to established giants, several emerging producers and regional players are expanding their capacity, driven by rising demand for lithium-based APIs in psychiatric medications. These include:
- Nanjing Chemlin Pharmaceutical (China)
- Dresden-based HTE - Hydrite Technology & Engineering (Europe)
- American Elements (USA)
These suppliers often serve niche markets, research institutions, or OEM (Original Equipment Manufacturer) companies.
Supply Chain Considerations
Quality Assurance & Certification: Suppliers must comply with major pharmacopeial standards (USP, EP, JP) and have robust cGMP certification. Validating supplier compliance minimizes manufacturing risks.
Regulatory Approvals: For pharmaceutical use, suppliers must demonstrate documentation for stability, purity, and cross-border regulatory approvals, including FDA, EMA, and PMDA.
Pricing & Lead Times: Geographical location influences costs and lead times. Asian suppliers typically offer more competitive pricing but may require rigorous validation for regulatory acceptance in Western markets.
Risk Management: Geographic concentration, political stability, and supply disruptions are considerations. Diversifying supplier base mitigates risks related to geopolitical issues or raw material shortages.
Market Trends Influencing Supplier Selection
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Increased demand for lithium-based mood stabilizers suggests an upward trajectory in lithium citrate procurement.
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Regulatory developments emphasizing stricter API standards are prompting pharmaceutical companies to prioritize suppliers with proven compliance histories.
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Sustainability initiatives are encouraging suppliers to adopt environmentally friendly manufacturing processes, influencing selection criteria.
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Vertical integration: Some large chemical companies are investing in upstream lithium extraction, potentially reducing dependency on external suppliers.
Conclusion
The pharmaceutical industry’s reliance on high-quality lithium citrate necessitates engagement with reputable, compliant suppliers. Established firms like Johnson Matthey and Sigma-Aldrich lead in global supply, providing consistent quality and regulatory assurance. Asian manufacturers, notably Tianjin Ruijiang and Shanxi Zhenhua, are significant players offering cost-effective alternatives, though often requiring rigorous qualification processes. Emerging suppliers and regional producers continue to diversify options, driven by rising demand. Strategic supplier evaluation—considering quality, regulatory compliance, reliability, and geopolitical factors—is essential for uninterrupted pharmaceutical manufacturing.
Key Takeaways
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Reliability & Quality: Partner with suppliers certified to global pharmaceutical standards (cGMP, ISO). Johnson Matthey and Sigma-Aldrich are industry leaders.
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Regulatory Compliance: Ensure suppliers provide comprehensive documentation for regulatory approval processes across jurisdictions.
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Geographical Diversification: Balance supply risk by leveraging both Western and Asian suppliers, considering lead times and costs.
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Cost Considerations: Chinese and Indian manufacturers offer competitive pricing but require thorough validation for regulatory acceptance.
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Market Trends & Innovation: Stay abreast of technological advancements in lithium extraction and synthesis, potentially reducing costs and environmental impact.
FAQs
1. What are the primary considerations when selecting a lithium citrate supplier for pharmaceutical manufacturing?
Quality assurance, regulatory compliance, manufacturing capacity, supply stability, and cost-effectiveness are critical factors.
2. Are there differences in pharmaceutical-grade lithium citrate supplied by various manufacturers?
Yes. Purity, consistency, and compliance with pharmacopeial standards (USP, EP, JP) vary; suppliers like Johnson Matthey maintain stringent quality controls suitable for pharmaceutical use.
3. How do regulatory agencies influence supplier choice for lithium citrate?
Authorities like the FDA and EMA require validated sources with documented compliance, affecting supplier qualification and approval pathways.
4. Can regional suppliers suffice for global pharmaceutical companies?
Yes, provided they meet international quality standards and have robust regulatory validation. Diversification mitigates risks of supply disruption.
5. Is there a trend towards sourcing lithium citrate from environmentally sustainable suppliers?
Increasingly, yes. Sustainability practices influence procurement decisions, encouraging manufacturers to prefer eco-friendly supply chains.
Sources
[1] Johnson Matthey Corporate Website. Pharmaceuticals Portfolio.
[2] Sigma-Aldrich Product Catalog.
[3] Tianjin Ruijiang Pharmaceutical Co., Ltd. Technical Data Sheets.
[4] International Pharmaceutical Regulators Forum. API Quality Standards.
[5] Market Reports on Lithium Salts in Pharmaceuticals.
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