ATRACURIUM BESYLATE PRESERVATIVE FREE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eugia Pharma	ATRACURIUM BESYLATE PRESERVATIVE FREE	atracurium besylate	INJECTABLE;INJECTION	206010	ANDA	AuroMedics Pharma LLC	55150-216-05	10 VIAL, SINGLE-USE in 1 CARTON (55150-216-05) / 5 mL in 1 VIAL, SINGLE-USE	2015-04-08
Hospira Inc	ATRACURIUM BESYLATE PRESERVATIVE FREE	atracurium besylate	INJECTABLE;INJECTION	090782	ANDA	Hospira, Inc.	0409-1109-01	10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1109-01) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-1109-11)	2013-02-25
Meitheal	ATRACURIUM BESYLATE PRESERVATIVE FREE	atracurium besylate	INJECTABLE;INJECTION	091488	ANDA	Meitheal Pharmaceuticals Inc.	71288-701-05	10 VIAL, SINGLE-DOSE in 1 CARTON (71288-701-05) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-701-06)	2018-05-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

Atracurium Besylate, a neuromuscular blocking agent, is widely employed in anesthesia to induce muscle relaxation during surgical procedures. Its preservative-free formulation is crucial for patients with sensitivities and for applications requiring minimized preservative exposure. Identifying reliable suppliers for preservative-free atracurium besylate is vital for pharmaceutical companies, healthcare providers, and distributors aiming to ensure high-quality, regulatory-compliant medicinal products.

This report reviews prominent suppliers offering preservative-free atracurium besylate, emphasizing their manufacturing capabilities, regulatory status, and global distribution networks. Accurate sourcing is essential for ensuring drug safety, efficacy, and compliance with international standards.

Regulatory Considerations for Preservative-Free Atracurium Besylate

Preservative-free formulations are typically manufactured under stringent Good Manufacturing Practices (GMP) to avert microbial contamination and preserve drug stability. Regulatory bodies such as the FDA (USA), EMA (Europe), and equivalent agencies worldwide enforce strict standards for preservative-free injectable drugs, necessitating reliable suppliers with validated processes and documentation.

Major Global Suppliers of Preservative-Free Atracurium Besylate

1. Hospira (Pfizer)

Overview: Hospira, a Pfizer subsidiary, has been a leading manufacturer of anesthetic and neuromuscular blocking agents, including atracurium besylate in preservative-free formulations.

Key Features:

Manufacturing facilities compliant with GMP regulations globally.
Product availability in multiple dosage forms for anesthesia care.
Regulatory approvals across North America, Europe, and Asia.
Supply chain: Extensive distribution network ensuring timely delivery worldwide.

Notes: Pfizer has recently streamlined its portfolio, but Hospira’s legacy remains a trusted source for high-quality, preservative-free atracurium besylate.

2. Fresenius Kabi

Overview: Fresenius Kabi specializes in infusion solutions, generic pharmaceuticals, and generics of neuromuscular blockers, including preservative-free atracurium besylate.

Key Features:

GMP-certified manufacturing sites in Europe, India, and the United States.
Product lines include both vials and prefilled syringes, designed specifically for preservative-free delivery.
Global presence ensures access across North America, Europe, Asia, and Africa.

Notes: Known for high-quality standards, Fresenius Kabi’s preservatives-free atracurium is frequently used in resource-limited settings and hospitals requiring preservative-free options.

3. Sandoz (Novartis)

Overview: Sandoz, as Novartis’s generics division, manufactures a spectrum of injectable neuromuscular blockers, including preservative-free atracurium besylate.

Key Features:

Scientifically validated processes conforming to international GMP standards.
Availability in various regions, especially Europe and North America.
Regulatory status: Approved by agencies such as the FDA and EMA.

Notes: Sandoz’s focus on biosimilars and generics affirms its commitment to quality and affordability.

4. Dr. Reddy’s Laboratories

Overview: An Indian multinational, Dr. Reddy’s supplies preservative-free atracurium besylate, primarily catering to Asian and global markets.

Key Features:

Manufactured in India under WHO-GMP compliant facilities.
Product portfolio includes sterile injectable neuromuscular blocking agents.
Regulatory approvals across multiple jurisdictions.

Notes: Cost-effective manufacturing combined with quality compliance makes Dr. Reddy’s a significant supplier for developing markets.

5. Hikma Pharmaceuticals

Overview: Hikma produces preservative-free atracurium besylate for diverse markets, emphasizing stringent quality controls.

Key Features:

GMP-certified manufacturing in the Middle East and Europe.
Product availability includes preservative-free vials for anesthesia.

Notes: Hikma's extensive distribution network enhances supply reliability.

Additional Notable Suppliers

Baxter International: Known for its portfolio of injectable drugs, including neuromuscular blockers, with preservative-free formulations.
Lupin Limited: An Indian pharmaceutical giant supplying generic anesthetics to global markets.
Viatris (formerly Mylan): Offers generic anesthetic agents, including preservative-free atracurium besylate.

Supply Chain and Market Dynamics

The availability of preservative-free atracurium besylate hinges on manufacturing capacity, regulatory approvals, and geopolitical considerations. Recent demand spikes, driven by the increased need for safe, preservative-free anesthetic agents, have prompted several suppliers to expand manufacturing capacity or establish new GMP-compliant facilities.

Additionally, regulatory agencies' evolving standards continue to influence supply dynamics. Suppliers investing in quality management systems aligned with ISO standards and GMP certifications generally achieve better market penetration and robustness against supply disruptions.

Regulatory and Quality Assurance

Choosing a supplier with validated manufacturing processes aligned with international standards is paramount. Regulatory approval status, Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) compliance underpin the credibility of preservative-free atracurium besylate supplied.

Importantly, suppliers should provide comprehensive documentation, including Certificates of Analysis (CoA), stability data, and process validation reports, to ensure product integrity.

Conclusion

Sourcing preservative-free atracurium besylate involves careful evaluation of supplier reputation, manufacturing standards, regulatory compliance, and distribution capabilities. The leading players—Hospira (Pfizer), Fresenius Kabi, Sandoz (Novartis), Dr. Reddy’s, and Hikma—are recognized for robust quality systems and global reach.

Businesses must continuously monitor regulatory landscapes and supply chain developments to ensure uninterrupted availability of this critical drug. Engaging with authorized distributors and verifying supplier certifications remains essential to mitigate risks associated with counterfeit or substandard products.

Key Takeaways

Global leaders in preservative-free atracurium besylate include Hospira (Pfizer), Fresenius Kabi, Sandoz, Dr. Reddy’s, and Hikma.
Regulatory compliance and GMP certification are critical indicators of supplier credibility.
Supply chain robustness depends on manufacturing capacity, geographic reach, and distribution agreements.
Quality documentation such as Certificates of Analysis (CoA) and stability data must be verified before procurement.
Market dynamics are influenced by regulation, demand fluctuations, and geopolitical factors; ongoing supplier evaluation is advised.

FAQs

1. Are there regional differences in suppliers for preservative-free atracurium besylate?
Yes. While global manufacturers like Pfizer and Fresenius serve multiple regions, some suppliers are more prominent in specific markets, such as India’s Dr. Reddy’s or Middle Eastern Hikma, due to regional manufacturing facilities and regulatory approvals.

2. What should I verify before selecting a supplier for preservative-free atracurium besylate?
Ensure the supplier has valid GMP certification, relevant regulatory approvals (FDA, EMA, etc.), comprehensive quality documentation, and a reliable supply history.

3. Can preservative-free atracurium besylate be sourced from small or emerging manufacturers?
It is possible, but rigorous due diligence on quality systems and regulatory compliance is essential. Larger, established suppliers generally offer greater assurance of product integrity.

4. How does regulatory approval impact the supply of preservatives-free atracurium besylate?
Regulatory approvals confirm that the product meets safety, efficacy, and quality standards, enabling legal distribution. Lack of approvals can limit market access and increase risks.

5. What future trends could influence suppliers of preservative-free atracurium besylate?
Emerging regulations favoring preservative-free formulations, technological advances in manufacturing, and increased demand for safer anesthetic agents are likely to shape supplier offerings and market competition.

References

[1] U.S. Food and Drug Administration (FDA), "Approved Drug Products with Therapeutic Equivalence Evaluations," 2022.
[2] European Medicines Agency (EMA), "Guidelines on the requirements for the manufacturing authorisation of medicinal products," 2023.
[3] World Health Organization (WHO), "Good Manufacturing Practices (GMP) for Medicines," 2021.
[4] Pharmaceutical commerce reports, "Global Market Overview of Neuromuscular Blocking Agents," 2022.
[5] Company websites and product catalogs from Hospira, Fresenius Kabi, Sandoz, Dr. Reddy’s, and Hikma.

Suppliers and packagers for ATRACURIUM BESYLATE PRESERVATIVE FREE