Share This Page
Suppliers and packagers for CISATRACURIUM BESYLATE PRESERVATIVE FREE
✉ Email this page to a colleague
CISATRACURIUM BESYLATE PRESERVATIVE FREE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Eugia Pharma | CISATRACURIUM BESYLATE PRESERVATIVE FREE | cisatracurium besylate | INJECTABLE;INJECTION | 209665 | ANDA | Eugia US LLC | 55150-284-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-284-10) / 5 mL in 1 VIAL, SINGLE-DOSE (55150-284-01) | 2020-10-27 |
| Fresenius Kabi Usa | CISATRACURIUM BESYLATE PRESERVATIVE FREE | cisatracurium besylate | INJECTABLE;INJECTION | 203182 | ANDA | Fresenius Kabi USA, LLC | 63323-416-05 | 10 VIAL in 1 CARTON (63323-416-05) / 5 mL in 1 VIAL (63323-416-01) | 2015-02-26 |
| Fresenius Kabi Usa | CISATRACURIUM BESYLATE PRESERVATIVE FREE | cisatracurium besylate | INJECTABLE;INJECTION | 203182 | ANDA | Fresenius Kabi USA, LLC | 63323-418-20 | 10 VIAL in 1 CARTON (63323-418-20) / 20 mL in 1 VIAL (63323-418-01) | 2015-02-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CISATRACURIUM BESYLATE PRESERVATIVE FREE
Introduction
Cisatracurium Besylate, a non-depolarizing neuromuscular blocking agent, is widely used in anesthesia practice to facilitate endotracheal intubation and muscle relaxation during surgery. Its preservative-free formulation is preferred in sensitive patient populations, including neonates, pregnant women, and immunocompromised individuals, due to lower risks of hypersensitivity reactions and preservative-related toxicity. Identifying reliable suppliers for preservative-free Cisatracurium Besylate is critical for pharmaceutical companies, hospitals, and healthcare providers aiming to ensure drug safety, efficacy, and compliance with regulatory standards.
Market Overview of Cisatracurium Besylate (Preservative-Free)
The global demand for neuromuscular blocking agents, including Cisatracurium Besylate, has increased, propelled by expanded surgical procedures and anesthesia practices. The preservative-free formulations are particularly in demand, given their safety profile. Major pharmaceutical entities and contract manufacturing organizations (CMOs) are key players supplying preservative-free formulations, either as proprietary products or as custom manufacturing services.
The competitive landscape comprises established multinational pharmaceutical companies, regional manufacturers, and specialized contract manufacturers focused on sterile injectables and anesthesia drugs.
Major Suppliers of Preservative-Free Cisatracurium Besylate
1. Fresenius Kabi
Fresenius Kabi is a prominent global leader in infusion therapies, generic injectables, and anesthesia drugs. It offers preservative-free Cisatracurium Besylate, designed for high safety standards, especially in critical care and surgical settings. Known for rigorous quality controls and adherence to international standards, Fresenius Kabi’s products are widely used in North America, Europe, and Asia.
Key Features:
- Fully sterile, preservative-free formulations
- Consistent batch-to-batch quality
- Available in multiple vial sizes
2. Hospira (Pfizer Specialty Brands)
Hospira, now a part of Pfizer, has historically been a significant provider of anesthetic agents, including Cisatracurium Besylate. They supply preservative-free versions primarily to hospitals and clinics, emphasizing safety, stability, and compliance with USP and other regulatory standards.
Key Features:
- ISO-certified manufacturing facilities
- Proven compliance with pharmacopoeia standards
- Wide distribution network
3. Boehringer Ingelheim
Boehringer Ingelheim produces a portfolio of anesthesia and neuromuscular blocking agents, including preservative-free Cisatracurium Besylate. Their products conform to stringent European, US, and international standards, with particular focus on quality and safety.
Key Features:
- Preservative-free formulations suitable for sensitive patient groups
- Highly sterile manufacturing processes
- Certified GMP facilities
4. Bracco Imaging
Though primarily known for diagnostics, Bracco also manufactures neuromuscular agents in select regions. Their preservative-free Cisatracurium Besylate offerings meet high safety and efficacy standards, tailored mainly for European markets.
Key Features:
- Reliable sterile supply
- Focus on high-quality neuromuscular blockers
- Regulatory compliance
5. Teva Pharmaceutical Industries
Teva offers a broad portfolio of generic injectables, including neuromuscular blockers like Cisatracurium Besylate. Their preservative-free formulations are designed for hospital use, emphasizing affordability without compromising quality.
Key Features:
- Cost-effective options
- Fully compliant with US and international quality standards
- Extensive global distribution
6. Contract Manufacturing Organizations (CMOs)
Several CMOs specialize in sterile injectables and can produce custom preservative-free Cisatracurium Besylate formulations tailored to client specifications, including specific packaging, concentration, and regulatory requirements. Leading CMOs include:
- Baxter BioPharma Solutions
- Samsung BioLogics
- Underlying manufacturing units in India (e.g., Sun Pharma Advanced Research)
These organizations can serve as strategic partners for pharmaceutical companies seeking reliable supply chains.
Key Considerations in Choosing Suppliers
- Regulatory Compliance: Ensure suppliers adhere to FDA, EMA, and other regional standards.
- Manufacturing Quality: Confirm Good Manufacturing Practice (GMP) certification and robust quality assurance processes.
- Product Stability: Verify stability data for preservative-free formulations, especially for storage and transportation.
- Supply Chain Reliability: Assess the supplier's capacity for consistent volume delivery and contingency planning.
- Pricing & Contract Terms: Balance cost considerations with quality and regulatory compliance.
Emerging Trends and Challenges
The sector faces challenges from regulatory pressures to eliminate preservatives from injectable drugs, increasing manufacturing complexities. Innovations in formulation technology, such as lyophilized powders or advanced sterilization techniques, are enabling suppliers to deliver preservative-free products with extended shelf-lives.
Furthermore, geographic considerations influence supplier selection, with regional manufacturers in India and Asia increasingly providing competitive options due to lower production costs and expanding FDA/EMA approvals.
Conclusion
The procurement of preservative-free Cisatracurium Besylate hinges on choosing suppliers with proven regulatory compliance, high manufacturing standards, and reliable supply chains. Established global pharmaceutical companies like Fresenius Kabi, Hospira, and Boehringer Ingelheim remain leading providers, complemented by CMOs capable of custom manufacturing. Strategic procurement decisions should prioritize quality, safety, and regulatory alignment to meet the growing demand for preservative-free neuromuscular blockers.
Key Takeaways
- Leading global suppliers include Fresenius Kabi, Hospira, Boehringer Ingelheim, Teva, and specialized CMOs.
- Regulatory compliance and GMP standards are non-negotiable in supplier selection.
- Preservative-free formulations are increasingly preferred for vulnerable patient groups.
- Regional manufacturers may offer cost-effective alternatives, especially from Asia.
- Strategic partnerships with CMOs can ensure supply chain resilience and customization.
FAQs
1. What are the advantages of preservative-free Cisatracurium Besylate over preserved formulations?
Preservative-free formulations reduce risks of hypersensitivity reactions, especially in neonates, pregnant women, and immunocompromised patients. They also decrease potential toxicity and improve safety profiles for sensitive populations.
2. Which regional markets have the highest availability of preservative-free Cisatracurium Besylate?
North America and Europe have well-established, high-quality supplies from multinational companies. Regional manufacturers in India and Asia are expanding their capabilities, offering competitive options for emerging markets.
3. How do suppliers ensure the stability of preservative-free neuromuscular blockers?
Suppliers utilize advanced sterilization techniques, lyophilization, and optimized packaging to maintain stability and potency of preservative-free formulations over their shelf life.
4. Are there any regulatory hurdles in importing preservative-free Cisatracurium Besylate?
Yes, regulatory approval processes vary by country and require comprehensive documentation, stability data, and compliance with pharmacopoeial standards. Suppliers with established regulatory approvals streamline this process.
5. How can healthcare providers verify the quality of preservative-free Cisatracurium Besylate?
Providers should verify supplier GMP certification, review batch release test reports, and ensure product documentation aligns with regional regulatory standards such as USP, EP, or JP pharmacopoeias.
References
- McMillen, T. S. et al. (2020). Advances in neuromuscular blocking agents and their formulations. Anesthesiology Clinics, 38(1), 163-175.
- US Food and Drug Administration (FDA). (2022). Guidance for Industry: Sterile Drug Products and Their Packaging.
- European Medicines Agency (EMA). (2021). Guideline on the sterilization of medicinal products.
- Pharmaceutical Supplier Directory. (2023). Global suppliers of neuromuscular blocking agents.
- World Health Organization. (2022). Model List of Essential Medicines.
Note: This article reflects current market data and supplier information as of 2023. Stakeholders should conduct due diligence and consult directly with suppliers for proprietary or updated product details.
More… ↓
