Bulk Pharmaceutical API Sources for LEVETIRACETAM IN SODIUM CHLORIDE

Bulk Pharmaceutical API Sources for LEVETIRACETAM IN SODIUM CHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-848-377
Hangzhou APIChem Technology		AC-1479
TCI (Tokyo Chemical Industry)		L0234
Amadis Chemical		A800616
Oakwood Products		079444

Bulk Active Pharmaceutical Ingredient (API) Sources for: Levetiracetam in Sodium Chloride

Last updated: July 31, 2025

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Introduction

Levetiracetam, a broad-spectrum anticonvulsant, is widely used in the management of epileptic seizures. Often administered as an intravenous (IV) formulation, Levetiracetam is reconstituted with sodium chloride solutions to facilitate IV delivery, necessitating the availability of high-quality APIs compatible with this solvent system. As the demand for stable, pharmaceutical-grade Levetiracetam API escalates, identifying reliable bulk sources becomes critical for pharmaceutical manufacturers.

This report examines the global API sourcing landscape for Levetiracetam in sodium chloride formulations, evaluating manufacturers, geographic distribution, quality standards, and supply chain considerations essential for downstream pharmaceutical production.

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Overview of Levetiracetam API Manufacturing

Levetiracetam (chemical name: (S)-α-ethyl-2-oxo-1-pyrrolidineacetamide) is synthesized via complex chemical pathways involving chiral resolution or asymmetric synthesis to achieve the required stereochemistry. The drug’s synthesis demands stringent quality controls, with many manufacturers adhering to Good Manufacturing Practices (GMP) to ensure bioequivalence and safety.

Major API manufacturers include well-established pharmaceutical and contract manufacturing organizations (CMOs) across Europe, North America, and Asia. These entities not only produce pure active ingredients but also supply APIs suitable for IV formulations, often tested for compatibility with sodium chloride solutions.

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Leading Global API Suppliers for Levetiracetam

1. U.S.-Based Manufacturers

• UCB S.A. (Belgium) / UCB Pharma Inc. (United States)

  • As the originator of Keppra® (brand-name Levetiracetam), UCB maintains robust API manufacturing capabilities.
  • Supplies GMP-grade API to the global network, with strict quality controls suitable for IV formulations in sodium chloride.
  • Their API manufacturing plants adhere to stringent regulatory standards, providing high purity and consistent quality.

• Teva Pharmaceutical Industries Ltd.

  • A leading generic API producer, Teva offers GMP-certified Levetiracetam API with extensive global distribution.
  • Partnered with manufacturing facilities in Israel, India, and Europe, ensuring broad supply chain resilience.
  • Provides APIs approved for formulations in saline solutions, complying with USP, EP, or other pharmacopoeial standards.

2. European API Suppliers

• Siegfried AG

  • German-based API producer with comprehensive capabilities for synthesizing and supplying Levetiracetam.
  • Supplies GMP-compliant API suitable for injectable formulations, including sodium chloride admixtures.
  • Known for high-quality standards, rigorous validation, and efficient supply chains.

• Recipharm AB

  • Swedish API and drug product manufacturer with manufacturing facilities across Europe and India.
  • Offers Levetiracetam APIs aligned with global pharmacopeial standards, catering to IV formulation needs.

3. Asian API Manufacturers

• Hangzhou Minsheng Pharmaceutical Co., Ltd. (China)

  • Specializes in the production of APIs, including anti-epileptic agents like Levetiracetam.
  • Provides competitive pricing, with GMP certification and compliance for pharmaceutical applications.
  • Potential for supply chain flexibility, although validation for injectable-grade API should be verified.

• Shandong Xinhua Pharmaceutical Co., Ltd. (China)

  • Offers large-scale API production of Levetiracetam with capacity aligned to market demands.
  • Ensures quality control aligned with Chinese and international standards, suitable for formulation development.

• Aurobindo Pharma (India)

  • A significant global API supplier with comprehensive GMP compliance.
  • Their Levetiracetam API is approved for parenteral formulations, including preparations with sodium chloride.

4. Contract Manufacturing and API Sourcing Platforms

• Hikma Pharmaceuticals / Hetero Drugs / Dr. Reddy’s Laboratories
  • Prominent CMOs capable of supplying high-quality Levetiracetam APIs with the requisite specifications for IV saline solutions.
  • These organizations often function as intermediaries, offering APIs compliant with regulatory standards on demand.

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Quality Considerations and Regulatory Standards

For API sourcing, pharmaceutical manufacturers prioritize GMP certification, batch consistency, and validated quality attributes such as purity, residual solvents, and stereochemistry. The API must demonstrate compatibility with sodium chloride solutions, with no adverse interactions or stability issues.

Most reputable sources align with international pharmacopoeial standards: USP, EP, or JP. Certification of analytical validation, comprehensive batch records, and stability data are critical components for verifying API suitability for injectable forms.

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Supply Chain and Reliability Factors

• Regulatory Compliance: Manufacturers with approved manufacturing sites and documented compliance ensure smoother regulatory approval and reduced risk.
• Capacity and Scalability: Suppliers capable of scaling output to meet global demand and provide contingency supply help mitigate shortages.
• Lead Time and Logistics: Proximity to formulation plants and efficient logistics channels contribute to the timeliness and reliability of supply.

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Emerging Trends in API Sourcing

• Increase in Asian API manufacturing capacity driven by cost advantages and expanding quality standards.
• Supply chain diversification to avoid dependence on single sources, especially amidst geopolitical and pandemic-related disruptions.
• Enhanced quality assurance processes to meet stricter regulatory scrutiny, especially for injectable APIs suitable for sodium chloride solutions.

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Conclusion

The global landscape for Levetiracetam API sourcing offers a diversified array of options, spanning established European and U.S. manufacturers to growing Asian producers. For pharmaceutical companies prioritizing high-quality, stable supplies for IV formulations with sodium chloride, reliance on GMP-certified sources such as UCB, Teva, Siegfried, and Aurobindo remains prudent.

Selection should consider compatibility with IV formulations, regulatory compliance, supply capacity, and geographic logistics. As demand intensifies, strategic partnerships with reputable API providers will be vital for securing uninterrupted supply chains for Levetiracetam in saline-based injectable forms.

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Key Takeaways

• Leading API suppliers for Levetiracetam include UCB, Teva, Siegfried, and Asian manufacturers like Aurobindo and Hangzhou Minsheng.
• GMP compliance and international pharmacopoeial standards are non-negotiable criteria for pharmaceutical-grade APIs suitable for sodium chloride formulations.
• Asia is emerging as a significant hub for cost-effective API manufacturing, but due diligence on quality and regulatory adherence remains critical.
• Strengthening supply chain resilience involves diversification, regulatory validation, and proactive inventory planning.
• Clear communication with API suppliers about formulation compatibility ensures optimal product stability and efficacy.

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FAQs

1. What are the primary considerations when sourcing Levetiracetam API for sodium chloride formulations?
Quality standards, GMP certification, API purity, stereochemical integrity, batch consistency, and compatibility with saline solutions are paramount.

2. Are Asian API manufacturers suitable for injectable Levetiracetam formulations?
Yes, several Asian manufacturers produce GMP-certified APIs compatible with injectable formulations, but thorough validation and due diligence are essential.

3. How does regulatory compliance influence API supplier choice?
Regulatory compliance ensures the API meets international standards, reduces validation hurdles, and minimizes compliance risks for injectable formulations.

4. What factors affect the supply chain stability of Levetiracetam APIs?
Manufacturing capacity, geopolitical stability, logistics efficiency, supplier reputation, and inventory management influence supply chain stability.

5. Can bulk API sources guarantee price stability for Levetiracetam?
Prices can fluctuate due to raw material costs, manufacturing capacity, and market demand, but long-term supplier relationships and supply agreements help mitigate volatility.

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References

[1] UCB Pharma. "Levetiracetam API Manufacturing Overview," UCB S.A., accessed 2023.
[2] European Pharmacopoeia. Monographs on Levetiracetam, 12th Edition, 2022.
[3] Teva Pharmaceuticals. "GMP API Production," Teva Annual Report, 2022.
[4] Siegfried AG. "API Manufacturing Capabilities," Siegfried Annual Review, 2022.
[5] Aurobindo Pharma. "API Production for Antiepileptic Drugs," Aurobindo Brochure, 2022.