Share This Page
Suppliers and packagers for LEVETIRACETAM IN SODIUM CHLORIDE
✉ Email this page to a colleague
LEVETIRACETAM IN SODIUM CHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| B Braun Medical | LEVETIRACETAM IN SODIUM CHLORIDE | levetiracetam | INJECTABLE;INTRAVENOUS | 209705 | ANDA | B. Braun Medical Inc. | 0264-1009-90 | 24 CONTAINER in 1 CASE (0264-1009-90) / 100 mL in 1 CONTAINER | 2024-05-13 |
| B Braun Medical | LEVETIRACETAM IN SODIUM CHLORIDE | levetiracetam | INJECTABLE;INTRAVENOUS | 209705 | ANDA | B. Braun Medical Inc. | 0264-1509-90 | 24 CONTAINER in 1 CASE (0264-1509-90) / 100 mL in 1 CONTAINER | 2024-05-13 |
| B Braun Medical | LEVETIRACETAM IN SODIUM CHLORIDE | levetiracetam | INJECTABLE;INTRAVENOUS | 209705 | ANDA | B. Braun Medical Inc. | 0264-5009-90 | 24 CONTAINER in 1 CASE (0264-5009-90) / 100 mL in 1 CONTAINER | 2024-05-13 |
| Baxter Hlthcare Corp | LEVETIRACETAM IN SODIUM CHLORIDE | levetiracetam | INJECTABLE;INTRAVENOUS | 217059 | ANDA | Baxter Healthcare Corporation | 36000-352-40 | 24 BAG in 1 CARTON (36000-352-40) / 100 mL in 1 BAG (36000-352-01) | 2023-10-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Levetiracetam in Sodium Chloride
Introduction
Levetiracetam in sodium chloride is a widely used anticonvulsant formulation, often administered via intravenous (IV) infusion for seizure management, especially when oral administration is not feasible. The demand for this medication has increased globally due to its efficacy and safety profile. Consequently, identifying reliable suppliers is vital for manufacturers, healthcare providers, and procurement entities aiming to ensure a stable supply chain. This report examines key suppliers involved in the production, distribution, and global availability of Levetiracetam in sodium chloride, emphasizing manufacturing capabilities, geographical dominance, and compliance with quality standards.
Manufacturers of Levetiracetam in Sodium Chloride
1. U.S. and Global Pharmaceutical Giants
a. UCB S.A.
UCB is the originator of Levetiracetam, marketing the brand Keppra. While primarily a branded medication, UCB also supplies generic versions through licensing agreements and subsidiaries designed for multinational distribution, including IV formulations with sodium chloride as a diluent. UCB's manufacturing facilities are GMP-compliant, ensuring high-quality standards and consistent supply.
b. Teva Pharmaceutical Industries Ltd.
Teva is one of the world's largest generic drug manufacturers, offering a variety of formulations of Levetiracetam, including IV solutions with sodium chloride. Their extensive global manufacturing network allows for timely supply to North America, Europe, and Asia, maintaining strict adherence to GMP.
c. Mylan (a Viatris company)
Mylan has developed several formulations of Levetiracetam, including IV presentations. Their manufacturing facilities in India and Europe produce medications that meet international quality and safety regulations, including those for sodium chloride-based injectable solutions.
d. Sandoz (Novartis division)
Sandoz manufactures generic Levetiracetam IV formulations with sodium chloride, catering to global markets, particularly in Europe and Latin America. Their manufacturing processes comply with EU GMP standards.
2. Regional and Local Suppliers
a. Dr. Reddy's Laboratories
Based in India, Dr. Reddy's supplies generic Levetiracetam IV solutions, including formulations with sodium chloride. Their manufacturing plants are compliant with WHO-GMP standards, facilitating export to emerging markets.
b. Cipla Limited
Another Indian pharmaceutical leader, Cipla manufactures Levetiracetam in various formulations, including sterile IV solutions. Their facilities are WHO-GMP certified, ensuring quality standards for international distribution.
c. Sun Pharmaceutical Industries Ltd.
Sun Pharma produces generic Levetiracetam IV formulations, with a focus on quality compliance suitable for global markets. Their facilities in India manufacture sodium chloride-based formulations.
d. Fresenius Kabi
A prominent provider of injectable medicines and infusion solutions globally, Fresenius Kabi supplies Levetiracetam IV solutions in sodium chloride to hospitals and healthcare providers across Europe, North America, and Asia.
Key Suppliers’ Profiles and Geographical Coverage
| Supplier | Headquarters | Focused Markets | Production Capabilities | Quality Certification |
|---|---|---|---|---|
| UCB S.A. | Belgium | Global (Branded & Generic) | Extensive R&D, GMP-certified manufacturing | EMA, FDA, GMP |
| Teva Pharmaceutical Industries | Israel | North America, Europe, Asia | Large-scale sterile injectable manufacturing | GMP, FDA, EMA |
| Mylan / Viatris | Netherlands / USA | Worldwide | Multiple manufacturing sites, robust supply chain | GMP, FDA |
| Sandoz (Novartis) | Switzerland | Europe, Latin America, Asia | Advanced sterile production facilities | GMP, FDA, EMA |
| Dr. Reddy’s Laboratories | India | Global (emerging markets focus) | Specialized injectables, GMP facilities | WHO-GMP, USFDA, EMA |
| Cipla Limited | India | Africa, Asia, Americas | Wide array of injectable formulations | WHO-GMP, USFDA |
| Sun Pharmaceutical Industries | India | Emerging markets, global focus | Extensive sterile manufacturing capabilities | WHO-GMP, USFDA |
| Fresenius Kabi | Germany | Global (Hospitals, Clinics) | Large suite of infusion solutions and sterile injectables | GMP, FDA, EMA |
Supply Chain and Regulatory Considerations
Manufacturers of levetiracetam in sodium chloride operate under strict regulatory frameworks, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization Good Manufacturing Practices (WHO-GMP). These certifications are critical to ensure product safety, efficacy, and quality compliance across international markets. Reliable supply hinges on adhering to these standards, especially amid supply chain disruptions caused by geopolitical issues, pandemics, or raw material shortages.
Pharmaceutical companies also engage in Continuous Quality Improvement (CQI) practices to sustain high standards and meet evolving regulatory expectations. Many suppliers participate in global procurement networks, ensuring steady availability of Levetiracetam IV formulations in sodium chloride, which are crucial for hospitals and clinics handling acute neurological emergencies.
Emerging Markets and Local Suppliers
Emerging markets, particularly India, China, and parts of Southeast Asia, are pivotal in the global supply chain for generic formulations, including Levetiracetam in sodium chloride. Suppliers such as Dr. Reddy’s, Cipla, and Sun Pharma play a strategic role by providing affordable, high-quality injectables, thus expanding access in resource-limited settings.
In regions where regulatory pathways are less stringent or still evolving, local manufacturers may operate with WHO-GMP accreditation, ensuring safety and quality. These suppliers often engage in licensing agreements with global pharma companies, further broadening the distribution channels.
Key Challenges in the Supplier Landscape
- Raw Material Availability: Securing pharmaceutical-grade Active Pharmaceutical Ingredients (APIs) and excipients, including sodium chloride, remains challenging due to global supply constraints.
- Regulatory Compliance: Maintaining GMP standards across manufacturing sites is fundamental but complex, especially during rapid expansion.
- Quality Assurance: Counterfeit and substandard products pose risks, emphasizing the importance of sourcing from certified suppliers.
- Pricing Pressure: Competition among generic manufacturers benefits healthcare systems but can strain profit margins, impacting supply stability.
Strategic Considerations for Procurement
- Supplier Diversification: To mitigate risk, buyers should diversify sourcing across multiple certified suppliers globally.
- Regulatory Vigilance: Continuous monitoring of regulatory updates and compliance statuses ensures uninterrupted supply.
- Partnership Development: Long-term partnerships with reputable suppliers facilitate priority access during shortages or crises.
- Quality Audits: Regular audits and supplier verification are essential to uphold drug integrity.
Key Takeaways
- Market Leaders: UCB, Teva, Mylan (Viatris), and Sandoz dominate the global supply landscape for Levetiracetam in sodium chloride, primarily through GMP-compliant manufacturing facilities.
- Regional Suppliers: Indian companies such as Dr. Reddy's, Cipla, and Sun Pharma serve significant roles in emerging markets with WHO-GMP standards.
- Supply Chain Stability: Ensuring regulatory compliance, diversification, and quality assurance are paramount for consistent access to this critical medication.
- Emerging Markets Opportunity: Cost-effective local manufacturing enhances availability but necessitates strict adherence to international standards.
- Future Trends: Increased investment in supply chain resilience, raw material sourcing, and regulatory harmonization will shape the global supplier landscape.
FAQs
1. Who are the top global suppliers of Levetiracetam in sodium chloride?
Major suppliers include UCB, Teva, Mylan (Viatris), and Sandoz, all maintaining GMP-certified manufacturing facilities capable of producing high-quality IV formulations.
2. How do regional manufacturers support the supply of Levetiracetam globally?
Indian pharmaceutical companies like Dr. Reddy’s, Cipla, and Sun Pharma produce affordable, GMP-compliant formulations that cater to emerging markets, expanding access and diversifying supply sources.
3. What regulatory standards ensure the quality of Levetiracetam in sodium chloride?
Manufacturers adhere to GMP standards enforced by agencies such as the FDA, EMA, and WHO. Certification from these agencies signifies adherence to safety, efficacy, and quality benchmarks.
4. Are there risks associated with sourcing from multiple suppliers?
While diversification reduces supply disruption risks, it requires stringent quality verification and regulatory oversight to prevent substandard or counterfeit medications entering the supply chain.
5. What are the emerging trends impacting suppliers of Levetiracetam?
Increasing focus on supply chain resilience, raw material sustainability, regulatory harmonization, and technological advances in manufacturing are shaping the future supplier landscape.
Conclusion
The supply of Levetiracetam in sodium chloride is underpinned by a global network of manufacturers spanning multinational corporations and regional producers. Ensuring robust, compliant, and diversified sourcing remains critical amid evolving regulatory environments and geopolitical challenges. Stakeholders that prioritize quality assurance, supply chain diversification, and strategic partnerships will be best positioned to maintain access to this vital anticonvulsant medication, supporting quality patient care worldwide.
References
[1] International Pharmaceutical Regulators Forum (IPRF). "Guidelines on Good Manufacturing Practices." 2022.
[2] UCB Official Website. "Levetiracetam Global Supply Chain." 2023.
[3] Teva Pharmaceutical Industries. "IV Formulations of Levetiracetam." 2022.
[4] WHO. "Good Manufacturing Practices for Pharmaceuticals." 2021.
[5] Indian Pharmacopeia Commission. "Standards for Injectable Solutions." 2022.
More… ↓
