Suppliers and packagers for STERILE WATER FOR INJECTION

STERILE WATER FOR INJECTION

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	STERILE WATER FOR INJECTION	sterile water for injection	LIQUID;N/A	209689	ANDA	Becton Dickinson and Company	17271-750-07	10 BAG in 1 CASE (17271-750-07) / 1000 mL in 1 BAG	2020-02-28
Fresenius Kabi Usa	STERILE WATER FOR INJECTION	sterile water for injection	LIQUID;N/A	209689	ANDA	Fresenius Kabi USA, LLC	63323-178-76	10 BAG in 1 CASE (63323-178-76) / 1000 mL in 1 BAG	2017-11-24
Hikma	STERILE WATER FOR INJECTION	sterile water for injection	LIQUID;N/A	206369	ANDA	Henry Schein, Inc.	0404-9781-10	1 VIAL in 1 BAG (0404-9781-10) / 10 mL in 1 VIAL	2025-08-28

Suppliers for the Pharmaceutical Drug: Sterile Water for Injection

Last updated: July 27, 2025

Introduction

Sterile water for injection (SWFI) is a fundamental component in pharmaceutical manufacturing, serving as a solvent for compounded medications, diluents for drug reconstitution, and critical in various sterile preparations. Due to its essential role, ensuring a consistent, high-quality supply chain is paramount for manufacturers, healthcare providers, and regulatory bodies. This article provides a comprehensive analysis of the leading suppliers of sterile water for injection, highlighting industry standards, key players, market dynamics, and procurement considerations vital for stakeholders.

Regulatory Standards and Quality Requirements

Before exploring specific suppliers, it is important to understand the regulatory landscape governing SWFI. The product must comply with pharmacopeial standards such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and other regional authorities. These standards specify criteria for sterility, pyrogenicity, endotoxin levels, pH, container integrity, and microbial barrier properties. Suppliers must adhere to current Good Manufacturing Practices (cGMP) and hold appropriate certifications, including ISO 9001, ISO 13485, and certifications from certifying agencies such as the FDA or EMA.

Key Attributes of Leading Suppliers

Suppliers of sterile water for injection often distinguish themselves through:

• Product Quality and Compliance: Ensuring consistent sterility, endotoxin levels, and absence of particulates.
• Manufacturing Capacity: Ability to meet global and regional demand, especially during supply chain disruptions.
• Global Reach and Distribution Networks: Efficient logistics to supply hospitals, pharmaceuticals, and laboratories worldwide.
• Regulatory Support: Assistance with regulatory filings, certificates of analysis, and compliance documentation.
• Innovative Packaging and Delivery Formats: Multilayered barrier packaging, single-use containers, and tailored delivery options.

Major Suppliers of Sterile Water for Injection

1. Hospira (Now Part of Pfizer)

As a global leader in sterile pharmaceuticals, Hospira (a Pfizer company) offers high-quality SWFI produced within strict compliance with pharmacopeial standards. Their products are characterized by extensive manufacturing facilities aligned with cGMP standards and robust supply chain capabilities, especially across North America, Europe, and Asia.

2. Fresenius Kabi

Fresenius Kabi is a prominent provider of sterile injectable solutions, including SWFI. Their manufacturing facilities comply with international regulatory standards, and they deliver a wide array of sterile water products suitable for immediate pharmaceutical use. Their global distribution network ensures compliance with regional standards and delivery reliability.

3. B. Braun Melsungen AG

B. Braun is renowned for sterile solutions, including SWFI, designed for pharmaceutical and hospital applications. Their manufacturing facilities have earned certifications from multiple regulatory authorities, and they emphasize product safety, purity, and traceability.

4. Baxter International

Baxter supplies sterile water for injection aimed at hospital and pharmaceutical ecosystems. They maintain high standards in sterilization processes and have comprehensive quality assurance systems aligned with global standards. Their focus on innovation includes containers designed for ease of use and sterility assurance.

5. Braun (Part of Becton Dickinson)

BD (Becton Dickinson) offers sterile water solutions, particularly targeting IV therapy and pharmacy compounding markets. Their manufacturing processes incorporate advanced sterilization techniques, validated for consistency, and their extensive distribution footprint ensures timely supply.

6. Local and Regional Suppliers

In addition to global giants, numerous regional manufacturers supply SWFI that meets regional pharmacopeial standards. These entities often serve specific markets with tailored packaging, regulatory assistance, and competitive pricing, albeit sometimes with varying levels of capacity and reach.

7. Contract Manufacturing and Custom Suppliers

Contract manufacturing organizations (CMOs) also produce sterile water for injection tailored to specific client specifications, especially for biotech firms or niche pharmaceuticals. These suppliers typically offer flexible manufacturing, supply chain optimization, and support for regulatory approvals.

Market and Supply Chain Dynamics

The global demand for sterile water for injection has escalated with the growth of sterile pharmaceutical production, biomedical research, and hospital drug preparations. The COVID-19 pandemic underscored vulnerabilities in supply chains, emphasizing the importance of diversified supplier portfolios and resilient logistics. Supply constraints can lead to shortages, impacting hospital operations and pharmaceutical manufacturing timelines.

Emerging trends include the shift towards adopting lyophilized, ready-to-use water solutions, and the development of tamper-evident packaging to prevent contamination. Additionally, sustainability considerations are influencing packaging innovations, encouraging suppliers to adopt eco-friendly materials and methods aligned with regulatory standards.

Procurement and Validation Considerations

Selecting an appropriate SWFI supplier involves evaluating:

• Regulatory Certifications: Confirm compliance with regional pharmacopeial standards.
• Quality Assurance Programs: Look for robust validation protocols, sterility testing, and endotoxin removal processes.
• Supply Reliability: Assess manufacturing capacity, lead times, and disaster recovery plans.
• Pricing and Contract Terms: Balance quality with cost-effectiveness, considering long-term supply stability.
• Customer Support Services: Ensure availability of regulatory documentation, complaint handling, and technical support.

Manufacturers often require supplier audits, qualification processes, and ongoing quality monitoring to establish compliant supply arrangements.

Conclusion

Suppliers of sterile water for injection occupy a critical position within global pharmaceutical and healthcare infrastructures. Leading firms such as Pfizer (Hospira), Fresenius Kabi, B. Braun, Baxter, and BD demonstrate strong adherence to regulatory standards, supply reliability, and quality assurance. In an evolving market influenced by regulatory vigilance, supply chain resilience, and technological innovation, prioritizing compliant, high-quality suppliers ensures uninterrupted operations. Strategic diversification and rigorous qualification processes are essential for mitigating risks associated with shortages, contamination, or regulatory non-compliance.

Key Takeaways

• Quality First: Prioritize suppliers complying with regional pharmacopeial standards and cGMP practices for sterile water for injection.
• Global and Regional Balance: Utilize a mix of global leaders and regional suppliers to enhance supply chain resilience.
• Regulatory Alignment: Ensure suppliers provide comprehensive documentation and certifications to facilitate regulatory submissions.
• Continuous Monitoring: Regular audits and quality assessments help maintain supply integrity and compliance.
• Innovation and Sustainability: Favor suppliers adopting environmentally sustainable practices without compromising sterility and quality.

FAQs

Q1: What are the primary regulatory standards for sterile water for injection?
A: The main standards include the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and other regional pharmacopeial guidelines, which specify criteria for sterility, endotoxin levels, and container integrity.

Q2: How can pharmaceutical companies ensure supplier quality for SWFI?
A: Through qualification audits, reviewing certifications such as ISO 9001, conducting ongoing quality monitoring, verifying compliance with pharmacopeial standards, and establishing robust supplier agreements.

Q3: What are the typical packaging formats for sterile water for injection?
A: SWFI is commonly packaged in single-use vials, ampoules, or large-volume containers, often with multilayered barrier films, sterile closures, and tamper-evident features.

Q4: Are regional suppliers suitable alternatives to global companies?
A: Yes, regional suppliers can fulfill specific market needs, often offering competitive pricing and tailored packaging, provided they meet regional regulatory requirements and maintain high quality standards.

Q5: How has the COVID-19 pandemic affected the supply of sterile water for injection?
A: The pandemic exposed vulnerabilities in global supply chains, leading to shortages, prompting diversification of suppliers, increased inventory buffers, and investments in manufacturing capacity and logistics to enhance resilience.

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Sources

[1] U.S. Pharmacopeia, https://www.usp.org/
[2] European Pharmacopoeia, https://www.edqm.eu/en/european-pharmacopoeia
[3] B. Braun Group, Corporate Reports, 2022
[4] Fresenius Kabi Official Website, https://www.fresenius-kabi.com/
[5] Pfizer, Corporate Overview, 2022
[6] Becton Dickinson (BD), Pharmaceuticals Solutions, 2022