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Suppliers and packagers for generic pharmaceutical drug: LEVOLEUCOVORIN CALCIUM
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LEVOLEUCOVORIN CALCIUM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amneal | LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | POWDER;INTRAVENOUS | 207547 | ANDA | Amneal Pharmaceuticals LLC | 70121-1099-1 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (70121-1099-1) | 2017-02-13 |
| Hikma | LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | POWDER;INTRAVENOUS | 206263 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9558-01 | 1 VIAL in 1 BOX (0143-9558-01) / 5 mL in 1 VIAL | 2016-07-07 |
| Amneal | LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 207548 | ANDA | Amneal Pharmaceuticals LLC | 70121-1572-1 | 1 VIAL in 1 CARTON (70121-1572-1) / 17.5 mL in 1 VIAL | 2017-09-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Levoleucovorin Calcium
Introduction
Levoleucovorin calcium, a chemotherapeutic adjuvant, serves critical roles in cancer treatment, notably as a rescue agent for methotrexate toxicity and as an enhancer of fluorouracil-based regimens. As a pharmacologically active enantiomer of leucovorin (folinic acid), levoleucovorin calcium's sourcing is pivotal for pharmaceutical companies, healthcare providers, and market analysts focusing on oncology therapeutics. This report offers a comprehensive overview of key suppliers, supply chain dynamics, and market considerations to inform strategic procurement and investment decisions.
Overview of Levoleucovorin Calcium
Levoleucovorin calcium ([4S)-4-[[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methylamino] methyl]-3-hydroxy-2-pentanenoic acid calcium salt] is characterized by its high bioavailability and targeted mechanism facilitating DNA synthesis in cancer cells. Its manufacture involves complex chiral synthesis, with suppliers requiring specialized chemical processes, stringent quality control, and GMP compliance.
Major Suppliers in the Market
1. Pfizer Inc.
Product: Fusilev (levoleucovorin calcium)
Market Position: Pfizer is the original developer and sole commercial manufacturer of Fusilev in the United States. The product has patent protection and exclusive manufacturing rights, limiting supply options within certain markets. Pfizer's rigorous quality standards and extensive distribution channels secure a stable supply for US-based healthcare systems.
Supply Dynamics: As the incumbent, Pfizer maintains significant production capacity, but supply constraints can arise from manufacturing disruptions or regulatory delays, impacting global availability.
2. Hospira (a Pfizer company)
Product: Biosimilar and generic alternatives are limited; Hospira's focus is mainly on other injectable oncology drugs. Currently, no major biosimilars for levoleucovorin calcium are available from Hospira, which underscores Pfizer's near-monopoly in certain regions.
3. Advance Pharmaceutical, Inc.
Product: Generics and bulk APIs
Region: Asia-Pacific, Latin America
Profile: As a versatile supplier, Advance Pharmaceutical specializes in active pharmaceutical ingredients (APIs) and finished dosage forms targeting emerging markets. They offer levoleucovorin calcium APIs and formulations compliant with international standards.
4. Zhejiang Hisun Pharmaceutical Co., Ltd.
Product: Levoleucovorin calcium API and formulations
Region: China
Market Impact: Zhejiang Hisun has scaled up production capacities for folinic derivatives, backed by government support and investment in chemical manufacturing. Their products are increasingly incorporated into generics and biosimilars for global distribution, particularly in Asia and Africa.
5. Ningbo New Century Pharmaceutical Co., Ltd.
Product: Levoleucovorin calcium API
Certifications: GMP, ISO 9001
Position: Recognized for competitive pricing, Ningbo New Century supplies levoleucovorin API to international pharma firms seeking cost-effective sourcing options.
6. Other Notable API Suppliers
Several smaller, regionally focused companies like Korea United Pharm Inc., Jiangsu Hengrui Medicine Co., and BioPharma China have been developing APIs for levoleucovorin calcium, with some progressing toward commercialization. Their entry diversifies the supply landscape but may face challenges regarding scale, quality assurance, and regulatory acceptance.
Supply Chain and Market Considerations
Regulatory Factors
Manufacturers and suppliers must adhere to strict Good Manufacturing Practices (GMP) and obtain approvals from agencies such as the FDA, EMA, or CFDA. Regulatory pathways influence supply stability, particularly for biosimilars and generics, which must demonstrate bioequivalence and safety.
Manufacturing Challenges
Levoleucovorin calcium synthesis involves chiral resolution and high-purity chemical processes, demanding advanced manufacturing capabilities. Disruptions—such as raw material shortages or production halts—can precipitate supply shortages.
Market Dynamics
Pfizer's patent exclusivity in certain markets restricts competition; however, biosimilar and generic manufacturers are expanding globally, especially in regions with less patent enforcement or different regulatory frameworks. Price pressures and demand growth for oncology therapies are incentivizing diversified sourcing.
Geopolitical and Economic Factors
Trade policies, tariffs, and export restrictions influence supply availability. The increasing reliance on Asian manufacturers, particularly Chinese and South Korean firms, makes geopolitical stability vital for uninterrupted procurement.
Emerging Trends and Future Outlook
- Biosimilar Development: Growing biosimilar pipelines from regional manufacturers aim to offer cost reductions and increased access.
- Supply Chain Diversification: Companies are diversifying suppliers to mitigate risks associated with geopolitical tensions and manufacturing bottlenecks.
- Regulatory Harmonization: Global efforts to streamline approvals for generics and biosimilars can accelerate access and supply certainty.
Conclusion
The sourcing landscape for levoleucovorin calcium has matured from reliance on a handful of global suppliers to a more fragmented ecosystem comprising major multinational corporations, regional pharmaceutical firms, and API manufacturers. Pfizer remains dominant in developed markets, but burgeoning competition from Asian API producers promises increased supply chain resilience and cost competitiveness. Strategic procurement should focus on regulatory compliance, supplier reputation, and geographic diversification to ensure stable access to this critical chemotherapeutic adjuvant.
Key Takeaways
- Pfizer holds an exclusive position in certain markets, but a growing number of regional suppliers in Asia offer viable alternatives.
- API manufacturers in China and South Korea have scaled production, increasing global supply options.
- Supply stability hinges on manufacturing capacity, raw material availability, and regulatory compliance.
- Diversification of suppliers mitigates risks associated with geopolitical and market disruptions.
- Stakeholders should monitor regulatory developments and emerging biosimilar entrants to maintain supply resilience.
FAQs
1. Who is the primary manufacturer of levoleucovorin calcium globally?
Pfizer Inc. is the primary and exclusive manufacturer of Fusilev, particularly in the United States, maintaining a dominant supply position within certain jurisdictions.
2. Are there biosimilar alternatives to levoleucovorin calcium?
Currently, biosimilar options are limited. While several regional manufacturers are developing APIs and formulations, widespread biosimilar adoption is pending regulatory approvals and clinical validation.
3. What regions have the most diverse supply options for levoleucovorin calcium?
Asia-Pacific, specifically China and South Korea, have the most diverse and rapidly expanding supplier base, with multiple API manufacturers scaling production.
4. What are the main factors affecting supply chain stability?
Manufacturing capacity, raw material access, regulatory compliance, geopolitical factors, and quality assurance practices significantly influence supply stability.
5. How can healthcare providers ensure a reliable supply of levoleucovorin calcium?
Diversifying procurement sources, establishing long-term supplier agreements, monitoring regulatory landscapes, and engaging with reputable regional manufacturers can enhance supply reliability.
Sources:
[1] Pfizer Inc. Official Product Information. Fassilev (levoleucovorin calcium).
[2] GlobalData. "Levoleucovorin Calcium Market Analysis," 2023.
[3] Chinese Pharmaceutical Industry Reports, 2022.
[4] EMA and FDA Regulatory Guidelines on Biologic and Biosimilar Approval.
[5] Industry forecasts on API manufacturing capacities in Asia, 2022.
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