EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare Corp	EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	epinephrine bitartrate	SOLUTION;INTRAVENOUS	218475	NDA	Baxter Healthcare Corporation	0338-0024-20	20 BAG in 1 CARTON (0338-0024-20) / 250 mL in 1 BAG	2025-02-28
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 8, 2025

Introduction

Epinephrine Bitartrate in 0.9% Sodium Chloride is a critical emergency medication used for anaphylaxis, cardiac arrest, and other life-threatening conditions. It is commonly supplied in injectable vials or pre-filled syringes, requiring high standards of purity, stability, and sterility. The distribution of this medication relies on reliable suppliers committed to quality assurance, regulatory compliance, and global distribution capabilities. This article provides an in-depth overview of key suppliers specializing in the manufacturing and distribution of Epinephrine Bitartrate in 0.9% Sodium Chloride, analyzing their market presence, regulatory standing, and strategic offerings.

Market Overview

The global demand for adrenaline (epinephrine) formulations remains robust, driven by the rising prevalence of allergic reactions, improved awareness, and evolving emergency response protocols. The pharmaceutical supply chain for epinephrine entails multiple stakeholders, including generic pharmaceutical manufacturers, branded drug companies, and contract manufacturing organizations (CMOs). Suppliers must adhere to stringent Good Manufacturing Practices (GMP), obtain approvals from authorities like the FDA, EMA, or other regulatory bodies, and meet international pharmacopoeia standards such as USP, EP, or JP.

Key Suppliers in the Market

1. Pfizer Inc.

As a leading innovator in emergency medications, Pfizer offers EpiPen® Auto-Injectors containing epinephrine, as well as injectable formulations in vials. While Pfizer primarily markets proprietary auto-injectors, the company's manufacturing facilities produce bulk epinephrine solutions suitable for hospital and pharmacy use. Pfizer's manufacturing sites comply with strict GMP standards, with certifications from major regulatory agencies.

Product Range: Auto-injectors and bulk injectable solutions of epinephrine.
Regulatory Status: Approved by FDA, EMA, and other agencies.
Distribution: Global supply chain, with regional manufacturing sites ensuring availability.

2. Baxter International Inc.

Baxter supplies emergency medications, including epinephrine in 1:1000 and 1:10,000 concentrations. Their formulations often contain epinephrine Bitartrate in saline solutions, focusing on hospital-grade injectable products. Baxter's manufacturing facilities operate under GMP and possess numerous certifications for sterility and quality management.

Product Range: Injectable epinephrine solutions, pre-filled syringes.
Regulatory Status: Approved by FDA, EMA, and others.
Market Reach: Extensive global distribution network.

3. Fresenius Kabi

Fresenius Kabi produces a broad portfolio of injectables, including epinephrine solutions for emergency use. Their products are manufactured in compliance with international standards, and they serve hospitals, clinics, and emergency services worldwide.

Product Range: Epinephrine Bitartrate in saline, pre-filled syringes, and vials.
Regulatory Certifications: GMP compliant with approval in multiple territories.
Unique Offerings: Emphasis on high-quality sterile formulations suitable for critical care.

4. Par Pharmaceutical (Part of Endo International)

Par Pharmaceutical has manufacturing capabilities for injectable epinephrine, including EPINEPHRINE BITARTRATE in saline solutions. They deliver both branded and generic formulations adhering to USP standards.

Product Range: Vials, ampoules, pre-filled syringes.
Quality and Compliance: GMP certifications, FDA approval.
Market Focus: North America, with expanding presence globally.

5. Sandoz (Novartis Division)

Sandoz specializes in generic injectables, including epinephrine solutions. Their manufacturing processes focus on biosimilarity, sterility, and efficacy, with extensive international registration.

Product Range: Generic epinephrine formulations.
Certifications: GMP, ISO compliant.
Distribution: Global, especially strong presence in Europe and emerging markets.

6. Mylan (Now part of Viatris)

Mylan produces generic injectables, including epinephrine solutions, with a focus on affordability and high-volume compliance manufacturing. Their product portfolio includes sterile vials suitable for emergency applications.

Product Range: Injectable epinephrine in vials.
Regulatory Approvals: FDA, EMA, and other agencies.
Global Reach: Wide distribution network, particularly in developing markets.

Emerging and Contract Manufacturers

Beyond established pharmaceutical companies, several contract manufacturing organizations (CMOs) and regional players supply bulk epinephrine for further formulation or distribution. These include companies like Samsung BioLogics, WuXi Biologics, and local Asian generic manufacturers, often serving as OEM suppliers for regional markets.

Regulatory and Quality Considerations

Suppliers for Epinephrine Bitartrate in 0.9% Sodium Chloride must demonstrate compliance with pharmacopoeial standards, with regular inspections by regulatory bodies. Ongoing stability testing, endotoxin control, and sterility assurance are primary quality concerns. Ensuring proper cold-chain logistics is vital to preserve potency and safety during transit. Certification and documentation—such as Certificate of Analysis (CoA), batch records, and GMP compliance—are critical when selecting suppliers.

Strategic Sourcing Factors

Regulatory approval status: Confirm that the supplier’s product has necessary approvals for the target market.
Manufacturing capacity: Assess ability to meet demand surges, especially during pandemics or large-scale emergency events.
Quality assurance: Verify compliance with GMP, stability data, and sterility assurance measures.
Distribution network: Evaluate their logistical capabilities to ensure timely delivery, especially to remote areas.

Conclusion

The supply of Epinephrine Bitartrate in 0.9% Sodium Chloride is dominated by major pharmaceutical players such as Pfizer, Baxter, Fresenius Kabi, Par Pharmaceutical, Sandoz, and Viatris (Mylan). These companies combine regulatory compliance, extensive manufacturing capacity, and global distribution reach to secure their market positions. Emerging manufacturers and CMOs complement this landscape, offering flexible sourcing options.

For healthcare providers and procurement agencies, choosing reputable suppliers with verified quality standards and reliable supply chains ensures optimal patient safety and uninterrupted access to this essential life-saving medication.

Key Takeaways

Major pharmaceutical companies like Pfizer, Baxter, and Fresenius Kabi dominate the supply landscape for epinephrine solutions, each emphasizing quality and regulatory compliance.
Regulatory approvals from agencies such as the FDA and EMA are non-negotiable criteria in supplier selection.
Due to the critical nature of epinephrine, manufacturers must maintain rigorous GMP standards, sterility, and stability testing.
Global distribution networks and cold-chain logistics are integral to ensuring drug efficacy at point-of-care.
Contract manufacturing organizations expand supply options but require thorough vetting to meet quality and regulatory standards.

Frequently Asked Questions

1. What are the primary regulatory considerations when sourcing Epinephrine Bitartrate solutions?
Suppliers must demonstrate compliance with GMP standards and possess approvals from regulatory agencies such as the FDA or EMA. Certificates of analysis, stability data, and sterility certifications are essential documentation.

2. How do manufacturing standards impact the safety of epinephrine solutions?
Strict adherence to GMP ensures sterility, potency, and purity, minimizing risks of contamination or degradation. Quality control measures, including endotoxin testing and stability assessments, safeguard patient safety.

3. Are there regional differences in supplier availability for Epinephrine Bitartrate solutions?
Yes. While global players maintain broad distribution, regional manufacturers may predominantly serve local markets, influenced by regulatory approvals, manufacturing capacity, and market demand.

4. What role do CMOs play in the supply chain?
Contract manufacturing organizations provideOEM production capabilities, often for generic formulations, enhancing supply flexibility and capacity. However, rigorous qualification processes are necessary to ensure compliance and quality.

5. How can healthcare providers ensure they source high-quality epinephrine solutions?
Procure from reputable suppliers with current regulatory approvals, GMP certifications, comprehensive documentation, and established cold-chain logistics. Regular audits and quality assurance checks are also recommended.

Sources:

[1] Pfizer Annual Product Portfolio, 2022.
[2] Baxter International Product Information, 2023.
[3] Fresenius Kabi Product Catalog, 2022.
[4] Par Pharmaceutical Regulatory & Quality Data, 2023.
[5] Sandoz Product Approvals, 2022.

Suppliers and packagers for EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE