Suppliers and packagers for LITHIUM CITRATE

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
Pai Holdings Pharm	LITHIUM CITRATE	lithium citrate	SYRUP;ORAL	070755	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1027-16	500 mL in 1 BOTTLE (0121-1027-16)	2026-04-14
Pai Holdings Pharm	LITHIUM CITRATE	lithium citrate	SYRUP;ORAL	070755	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-4027-94	3 TRAY in 1 CASE (0121-4027-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4027-05)	2026-04-14
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

Lithium Citrate: Supplier Landscape and Market Dynamics

Last updated: February 19, 2026

This report analyzes the supplier landscape for lithium citrate, a compound used in pharmaceutical formulations. It examines key manufacturers, production capacities, regulatory considerations, and market trends impacting supply chain stability and pricing.

Who Are the Leading Suppliers of Pharmaceutical-Grade Lithium Citrate?

The global supply of pharmaceutical-grade lithium citrate is concentrated among a limited number of manufacturers, primarily in Asia and Europe. These suppliers meet stringent quality control and regulatory standards required for pharmaceutical use.

• Tresco Manufacturing Company (China): A significant producer, Tressco manufactures various lithium salts, including lithium citrate, for diverse applications, including pharmaceutical and industrial uses. Specific production capacities for pharmaceutical-grade lithium citrate are not publicly disclosed but are understood to be substantial.
• CordenPharma (Germany): CordenPharma is a Contract Development and Manufacturing Organization (CDMO) that produces active pharmaceutical ingredients (APIs) and intermediates. They offer lithium citrate as part of their specialized chemical synthesis services. Production scale is adaptable to client demand.
• Albemarle Corporation (United States): While primarily known for battery-grade lithium, Albemarle also produces lithium compounds for specialized applications. Their pharmaceutical-grade lithium citrate production is focused on niche markets and adheres to strict cGMP (current Good Manufacturing Practice) standards.
• Chemsrc (China): Chemsrc is a chemical supplier that offers a range of pharmaceutical intermediates and APIs. They list lithium citrate among their offerings, catering to research and industrial clients. Details on dedicated pharmaceutical-grade production lines and capacities are proprietary.
• Fisher Scientific (United States): As a distributor, Fisher Scientific provides a wide array of laboratory chemicals, including lithium citrate. They source from various manufacturers and ensure products meet relevant purity standards for research and some pharmaceutical applications.

What are the Key Specifications and Quality Standards for Pharmaceutical Lithium Citrate?

Pharmaceutical-grade lithium citrate must adhere to rigorous specifications to ensure patient safety and drug efficacy. These standards are typically defined by pharmacopoeias and regulatory bodies.

• Purity: Typically, lithium citrate for pharmaceutical use must meet a minimum purity of 99.0% or higher. Impurity profiles are critical, with strict limits on heavy metals, arsenic, and other toxic elements.
• Identification: Tests are conducted to confirm the presence of lithium ions and citrate ions, often using techniques like flame photometry for lithium and titrimetric methods for citrate.
• Assay: The precise concentration of lithium citrate is determined through quantitative analysis.
• Water Content: Limits on residual moisture are specified to ensure stability. Karl Fischer titration is a common method for determination.
• Heavy Metals: Limits for specific heavy metals (e.g., lead, cadmium, mercury) are set at parts per million (ppm) levels, often < 10 ppm or < 5 ppm.
• Arsenic: A strict limit for arsenic, typically < 2 ppm, is enforced.
• Chloride and Sulfate: Limits on these ions are defined to prevent contamination.
• Appearance: The substance is usually described as a white, crystalline powder.
• Solubility: Solubility in water is a key characteristic, typically described as freely soluble.

These specifications are often aligned with monographs in major pharmacopoeias such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.). Manufacturers supplying the pharmaceutical industry must demonstrate compliance through Certificates of Analysis (CoA) for each batch.

What is the Global Production Capacity and Availability of Lithium Citrate?

Precise global production capacity figures for pharmaceutical-grade lithium citrate are not publicly disclosed by manufacturers, as this data is often considered proprietary and competitive. However, several factors influence its availability:

• Dual-Use Nature: A significant portion of global lithium production is dedicated to battery-grade lithium carbonate and lithium hydroxide for the electric vehicle and electronics industries. Pharmaceutical-grade production represents a smaller, specialized segment.
• Manufacturing Complexity: Producing pharmaceutical-grade chemicals requires adherence to cGMP, specialized equipment, and robust quality assurance systems, which increases production costs and limits the number of qualified manufacturers.
• Raw Material Sourcing: The primary raw material is lithium carbonate or lithium hydroxide, sourced from brine operations (e.g., South America) or hard-rock mining (e.g., Australia). The availability and price volatility of these raw materials can impact lithium citrate supply.
• Geographic Concentration: Production is concentrated in regions with established chemical manufacturing infrastructure and regulatory oversight. China and Europe are key manufacturing hubs.
• Demand Fluctuations: Demand for pharmaceutical lithium citrate is driven by its use in specific medications, particularly for mood stabilization (e.g., bipolar disorder). Fluctuations in prescription rates for these drugs directly affect demand.

While exact figures are scarce, industry analysts estimate that global capacity for pharmaceutical-grade lithium citrate is sufficient to meet current demand, but potential bottlenecks could arise from disruptions in raw material supply, increased regulatory scrutiny, or sudden spikes in demand for specific applications.

What are the Regulatory Requirements for Lithium Citrate Suppliers?

Suppliers of pharmaceutical-grade lithium citrate must navigate a complex web of international and national regulations to ensure product safety and efficacy.

• Current Good Manufacturing Practices (cGMP): Manufacturers must operate facilities that comply with cGMP guidelines established by regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This includes rigorous controls over manufacturing processes, quality control, documentation, and personnel.
• Drug Master Files (DMFs): Suppliers often file DMFs with regulatory authorities. A DMF provides confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows drug product manufacturers to reference the DMF in their own regulatory submissions without revealing proprietary information to the drug product manufacturer.
• Pharmacopoeial Compliance: Products must meet the specifications outlined in relevant pharmacopoeias, such as the USP, Ph. Eur., or Japanese Pharmacopoeia (JP). Compliance must be validated and documented.
• ISO Certifications: While not always mandatory for pharmaceutical use, ISO 9001 (Quality Management Systems) and ISO 14001 (Environmental Management Systems) certifications demonstrate a supplier's commitment to quality and responsible operations.
• REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals): For suppliers exporting to the European Union, compliance with REACH regulations is necessary, which involves registering chemical substances and assessing their risks.
• Supply Chain Traceability: Robust systems for tracking raw materials, intermediates, and finished products are essential. This ensures accountability and facilitates recalls if necessary.

What are the Key Market Trends and Challenges Affecting Lithium Citrate Supply?

The market for pharmaceutical-grade lithium citrate is influenced by several macroeconomic, technological, and regulatory factors.

• Raw Material Price Volatility: The price of lithium carbonate and hydroxide, the primary precursors, is subject to significant volatility driven by global demand for batteries, geopolitical factors, and supply chain disruptions. This directly impacts the cost of lithium citrate production.
• Geopolitical Influences: Concentration of lithium reserves and processing in specific geographic regions can create supply chain vulnerabilities due to trade policies, political instability, or logistical challenges.
• Increasing Regulatory Scrutiny: Global regulatory bodies continue to enhance oversight of pharmaceutical ingredient quality and manufacturing. This necessitates ongoing investment by suppliers in compliance, validation, and quality management systems.
• Demand from Emerging Markets: Growing healthcare access and an aging population in emerging markets can drive increased demand for pharmaceuticals, including those utilizing lithium citrate.
• Competition from Alternative Treatments: The development of new pharmaceutical therapies for conditions treated with lithium citrate could impact its long-term demand.
• Sustainability Initiatives: Increasing emphasis on environmental sustainability throughout the supply chain may influence sourcing decisions and manufacturing processes. This includes responsible mining practices and waste reduction.
• Consolidation in the Chemical Industry: Mergers and acquisitions within the specialty chemical sector can alter the supplier landscape, potentially leading to fewer but larger suppliers or changes in product portfolios.
• Supply Chain Resilience: Recent global events have highlighted the importance of supply chain resilience. Pharmaceutical companies are increasingly seeking to diversify their supplier base and ensure robust contingency plans.

Key Takeaways

The pharmaceutical lithium citrate market is characterized by a specialized supplier base, stringent regulatory requirements, and a sensitivity to raw material price fluctuations. Key manufacturers are primarily located in China and Europe, with adherence to cGMP and pharmacopoeial standards being non-negotiable. Raw material volatility, geopolitical risks, and evolving regulatory landscapes represent the primary challenges influencing supply chain stability and pricing for this critical pharmaceutical ingredient.

Frequently Asked Questions

What is the primary therapeutic use of lithium citrate in pharmaceuticals?

Lithium citrate is primarily used in the treatment of bipolar disorder, acting as a mood stabilizer. It is also explored for other neurological and psychiatric conditions.

How does pharmaceutical-grade lithium citrate differ from industrial-grade lithium citrate?

Pharmaceutical-grade lithium citrate must meet exceptionally high purity standards, with strict limits on heavy metals and other impurities, and must be manufactured under cGMP conditions. Industrial-grade lithium citrate has less stringent purity requirements and is not intended for human consumption.

What is the typical shelf life of pharmaceutical-grade lithium citrate?

The typical shelf life is generally between two to five years when stored under appropriate conditions (cool, dry, and protected from light), as specified by the manufacturer.

Are there any significant supply chain risks associated with lithium citrate?

Yes, key risks include the volatility of lithium raw material prices, geopolitical instability in sourcing regions, potential disruptions in global logistics, and increasing regulatory compliance burdens for manufacturers.

How can a pharmaceutical company ensure the quality and reliability of its lithium citrate suppliers?

Companies can ensure quality and reliability through thorough supplier audits, reviewing DMFs and Certificates of Analysis, implementing robust incoming material testing protocols, and maintaining diversified supplier relationships.

What are the main pharmacopoeial standards that lithium citrate for pharmaceutical use must meet?

The primary pharmacopoeial standards are typically those set forth in the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.).

Citations

[1] U.S. Food and Drug Administration. (n.d.). Guidance for Industry: ANDAs To Use Drug Master Files (DMFs). Retrieved from [FDA website - specific guidance document URL would be inserted here if available and directly relevant]

[2] European Medicines Agency. (n.d.). EudraLex Volume 4: Good Manufacturing Practice. Retrieved from [EMA website - specific guidance document URL would be inserted here if available and directly relevant]

[3] United States Pharmacopeial Convention. (n.d.). United States Pharmacopeia General Chapters. Retrieved from [USP website - specific chapter information would be detailed here if applicable]

[4] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia. Retrieved from [EDQM website - specific information would be detailed here if applicable]

[5] European Chemicals Agency. (n.d.). REACH Regulation. Retrieved from [ECHA website - specific information would be detailed here if applicable]