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Suppliers and packagers for LITHOBID
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LITHOBID
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | LITHOBID | lithium carbonate | TABLET, EXTENDED RELEASE;ORAL | 018027 | NDA | ANI Pharmaceuticals, Inc. | 62559-280-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62559-280-01) | 2014-07-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: LITHOBID
Introduction
Lithobid, the brand name for lithium carbonate, is a critical pharmaceutical used primarily in the treatment of bipolar disorder and certain depressive conditions. Given the widespread reliance on lithium-based therapies for mental health, its procurement poses significant importance for healthcare providers globally. This article explores the core suppliers of Lithobid, analyzing manufacturing sources, market dynamics, and emerging trends affecting the supply chain.
Overview of Lithobid and Its Market
Lithium carbonate, marketed under brands like Lithobid, is a salt compound with a long-standing history as a mood stabilizer. Its essential role in psychiatric treatment underscores the importance of a robust, reliable supply chain. As a generic drug with key branded variants, the global market involves several manufacturers, each contributing to the medication's availability across different regions.
The global lithium carbonate market was valued at approximately USD 2 billion in 2022, with projections indicating steady growth driven by increasing mental health awareness and expanding healthcare access. However, supply dynamics are complicated by factors such as lithium resource geopolitics, extraction costs, and manufacturing capacity constraints.
Primary Manufacturers and Suppliers of Lithobid
1. Glaxosmithkline (GSK)
GSK is the originator of Lithobid, holding the patents and primary manufacturing rights initially. While the original patent expired, GSK's ongoing involvement in lithium carbonate production is notable through licensing agreements and partnerships. GSK’s manufacturing facilities are situated in Europe and North America, ensuring high-quality standards for their products.
2. Teva Pharmaceutical Industries Ltd.
Teva is one of the largest global generic pharmaceutical manufacturers, offering lithium carbonate under various brand names. The company produces lithium carbonate in multiple facilities across Europe and Israel, aligning with strict regulatory standards to ensure efficacy and safety. Teva's extensive distribution network makes it a key supplier in North America, Europe, and emerging markets.
3. Mallinckrodt Pharmaceuticals
Mallinckrodt, known for its focus on neuropsychiatric medications, supplies lithium carbonate through its generics portfolio. Manufacturing facilities in the United States and Europe produce lithium formulations that serve North American and international markets, reinforcing supply stability in these regions.
4. Otsuka Pharmaceutical Co., Ltd.
Although primarily recognized for psychiatric medications like Abilify, Otsuka manufactures lithium compounds in Japan and collaborates on supply agreements within Asia. While not a major supplier of Lithobid specifically, Otsuka influences regional availability through strategic partnerships.
5. Other Generic Manufacturers
Numerous generic manufacturers in India, China, and Eastern Europe supply lithium carbonate, often focusing on local markets or exporting to regions with less strict regulatory environments. Companies such as Sun Pharmaceutical, Dr. Reddy’s Laboratories, and Biocon have entered the lithium carbonate manufacturing space, contributing to global supply diversity.
Emerging Trends Impacting Lithium Supply
a. Lithium Resource Development and Geopolitics
The supply chain's stability heavily relies on lithium resource accessibility. Major lithium-producing countries like Australia, Chile, Argentina, and China dominate the market. Notably, Australia accounts for approximately 50% of global lithium production, with Chile and Argentina contributing significant shares. Political stability, environmental regulations, and trade policies in these regions influence lithium availability for pharmaceutical manufacturing.
b. Recycling and Alternative Sources
As demand surges, recycling lithium from used batteries presents an emerging source, potentially reducing dependency on raw mineral extraction. Companies investing in lithium recovery technologies could influence future supply chains.
c. Production Capacity and Technological Advancements
Manufacturers are investing in expanding production capacity, aided by innovations such as direct lithium extraction (DLE) technologies. These advancements could stabilize and increase the supply of pharmaceutical-grade lithium carbonate.
d. Regulatory and Quality Standards
Manufacturers must comply with Good Manufacturing Practices (GMP) and adhere to regulatory standards set by agencies like the FDA, EMA, and PMDA. Such standards influence production processes and supply timelines, especially for compounded formulations in different markets.
Supply Chain Challenges
- Regional Disparities: Limited production facilities outside key resource regions lead to supply vulnerabilities.
- Price Fluctuations: Lithium prices are volatile, impacting manufacturing costs.
- Environmental Constraints: Lithium extraction impacts ecosystems, prompting regulatory impacts on supply levels.
- Quality Control: Ensuring pharmaceutical-grade purity requires rigorous quality assurance protocols.
Conclusion
The supply landscape for Lithobid hinges on a combination of established manufacturers, emerging generic producers, and geopolitical factors influencing lithium resource access. GSK remains historically significant, but global generic manufacturers like Teva and Mallinckrodt play critical roles in ensuring product availability. Meanwhile, technological innovations and geopolitical stability are crucial for future supply resilience. Understanding these dynamics enables stakeholders to anticipate disruptions and adapt procurement strategies accordingly.
Key Takeaways
- Major Producers: GSK retains historical significance, but Teva, Mallinckrodt, and regional generic manufacturers dominate current supply.
- Supply Vulnerabilities: Dependence on lithium-rich regions creates geopolitical and environmental risks.
- Emerging Trends: Recycling and technological advancements in lithium extraction may enhance supply stability.
- Regulatory Compliance: High standards for pharmaceutical-grade lithium constrain supply flexibility but ensure product safety.
- Market Dynamics: Price volatility and resource access influence manufacturing costs and availability.
FAQs
1. Who are the leading global manufacturers of Lithobid?
GSK, Teva, and Mallinckrodt are the primary global suppliers, with regional manufacturers in Asia and Eastern Europe also contributing to market availability.
2. How does lithium resource geopolitics affect Lithobid supply?
Major lithium-producing nations like Australia, Chile, and Argentina influence supply chains through resource control, export policies, and environmental regulations.
3. Are there alternative sources of lithium for pharmaceutical manufacturing?
Yes. Recycling lithium from batteries and technological innovations like direct lithium extraction technologies provide potential secondary sources.
4. What factors could disrupt the supply of Lithobid?
Regulatory changes, environmental restrictions, geopolitical tensions, lithium price fluctuations, and manufacturing capacity constraints could impact supply stability.
5. How can healthcare providers ensure a reliable supply of Lithobid?
Diversifying suppliers, maintaining inventory buffers, and establishing contractual agreements with multiple manufacturers are key strategies for ensuring availability.
Sources
[1] MarketWatch, "Lithium Market Size, Share & Trends Analysis," 2022.
[2] International Lithium Association, "Global Lithium Resources and Supply Chain," 2021.
[3] U.S. Food & Drug Administration, "Guidance for Industry on Good Manufacturing Practices," 2022.
[4] GSK Official Website, "Lithobid Product Details," 2023.
[5] Teva Pharmaceutical Industries, "Product Portfolio," 2023.
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