Suppliers and packagers for BALANCED SALT

BALANCED SALT

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	BALANCED SALT	calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate	SOLUTION;IRRIGATION	091387	ANDA	B. Braun Medical Inc.	0264-1945-10	500 mL in 1 BAG (0264-1945-10)	2022-01-28

Last updated: August 4, 2025

ppliers for the Pharmaceutical Drug: Balanced Salt

Introduction
Balanced Salt Solution (BSS) is a sterile, isotonic fluid commonly used in medical and ophthalmological procedures, along with pharmaceutical formulations requiring electrolyte balance. The demand for high-quality BSS instigates a dynamic supply market comprising global manufacturers and suppliers adhering to strict quality standards. This article offers a comprehensive overview of key suppliers of Balanced Salt solutions, focusing on their geographic distribution, certifications, product specifications, and strategic positioning within the pharmaceutical supply chain.

Market Overview of Balanced Salt Suppliers
The global supply of Balanced Salt solutions predominantly features companies operating within established pharmaceutical manufacturing hubs such as North America, Europe, and Asia. The market's evolution is driven by stringent regulatory requirements (FDA, EMA, ISO standards), technological advancements in sterile production, and increasing application domains including ophthalmology, cell therapy, and research laboratories.

Leading Suppliers of Balanced Salt Solutions

1. B. Braun Melsungen AG
Overview: German healthcare giant B. Braun is a prominent manufacturer of sterile solutions including Balanced Salt Solutions used in surgeries and dialysis. Their BSS products are distinguished by compliance with ISO and USP standards.
Product Range: B. Braun offers various formulations, including Balanced Salt Solutions for ophthalmic procedures (e.g., BSS Plus), emphasizing purity, isotonicity, and compatibility.
Certifications: ISO 13485, GMP, FDA approval, CE marking.
Strategic Positioning: B. Braun's extensive distribution network and rigorous quality control make it a key supplier globally, especially in North America and Europe.

2. Baxter International Inc.
Overview: Baxter supplies a range of intravenous fluids, including Balanced Salt solutions, tailored for clinical and laboratory applications.
Product Range: Baxter’s BSS products are designed for compatibility with ocular and surgical procedures, with options optimized for pH and osmolarity.
Certifications: FDA, ISO 13485, CE marking, and GMP compliance.
Strategic Positioning: Baxter’s global footprint, especially in North America, Latin America, and Asia, positions it as a primary source for sterile balanced salt solutions.

3. Fresenius Kabi AG
Overview: A leading German provider of infusion solutions, Fresenius Kabi offers balanced salt formulations with a focus on pediatric, adult, and specialty needs.
Product Range: Their balanced salts are used in clinical settings, including customized solutions.
Certifications: ISO 13485, GMP, FDA approval.
Strategic Positioning: With strong presence across Europe, Asia, and North America, Fresenius Kabi leverages robust manufacturing capacities and a diversified product portfolio.

4. Geo-Science, Inc.
Overview: An American based specialty supplier focusing on pharmaceutical and research-grade salt solutions, including BSS.
Product Range: Standard and high-purity formulations suitable for laboratory and clinical use.
Certifications: cGMP, ISO compliant manufacturing facilities.
Strategic Positioning: Their niche focus and high purity standards position Geo-Science as an ideal supplier for research institutions and pharmaceutical companies seeking custom formulations.

5. Roar Biomedical
Overview: Specializing in ophthalmic-preserving solutions, Roar Biomedical manufactures Balanced Salt Solutions tailored for perioperative and research applications.
Product Range: Includes formulations for intraocular procedures and compatibility with ocular medications.
Certifications: GMP, ISO 13485, CE certification.
Strategic Positioning: Focused on ophthalmology, Roar Biomedical’s niche expertise makes it a strategic partner for ophthalmic pharmaceutical companies.

Regional Considerations and Supply Chain Dynamics
While North American and European companies dominate large-scale sterile solution manufacturing, Asian players such as Wockhardt (India) and Jiangsu Hengrui Medicine Co. Ltd. are expanding their footprints, driven by cost advantages and growing domestic markets. Regulatory accreditation (e.g., FDA, EMA, and PMDA certifications) significantly influences supplier credibility and market access.

Quality and Regulatory Compliance
Suppliers must adhere to GMP standards, ISO certifications, and regional regulatory approvals to ensure product safety and efficacy. Many top-tier suppliers facilitate certification readiness through rigorous quality management systems and transparent supply chain documentation.

Emerging Trends and Strategic Considerations

• Customization and Specialty Formulations: Suppliers increasingly offer tailored formulations, integrating specific electrolyte concentrations or buffering agents to meet unique clinical needs or research protocols.
• Supply Chain Resilience: Companies investing in diversified manufacturing capabilities and geographic presence aim to mitigate risks associated with geopolitical tensions, pandemic disruptions, and raw material shortages.
• Digitalization and Traceability: Enhancing quality assurance via digital tracking, batch traceability, and real-time quality monitoring strengthen supply chain integrity and customer confidence.

Conclusion
The market for Balanced Salt solutions features a mix of established pharmaceutical giants and specialized niche suppliers, each leveraging geographic strengths and regulatory compliance to meet global demand. Companies seeking reliable BSS suppliers should prioritize those with validated certifications, proven quality management systems, and a strategic geographic presence that aligns with supply chain demands.

Key Takeaways

• Top global suppliers include B. Braun, Baxter, Fresenius Kabi, Geo-Science, and Roar Biomedical, with strong regional footprints.
• Regulatory compliance (FDA, EMA, ISO) remains critical for supplier qualification and market access.
• Customization capabilities and supply chain resilience are increasingly vital in supplier evaluation.
• Asia's expanding manufacturing capacity offers competitive alternatives but requires rigorous quality validation.
• Digital traceability enhances quality assurance and risk management in procurement processes.

FAQs

1. What criteria are most important when selecting a Balanced Salt Solution supplier?
Quality certifications (GMP, ISO), regulatory approvals (FDA, EMA), product purity, customization options, supply stability, and geographic coverage are key factors.

2. Are there regional differences in Balanced Salt Solution suppliers?
Yes. North America and Europe dominate high-standard production with strict regulatory adherence. Asian suppliers are expanding, offering cost advantages and increasing competitive options.

3. How do regulatory standards impact supplier choices?
Regulatory standards ensure product safety and efficacy. Suppliers with certifications like FDA approval and ISO 13485 are preferred, especially for clinical and pharmaceutical applications.

4. Can suppliers provide custom or specialized Balanced Salt Solutions?
Yes. Many top suppliers offer customization for electrolyte composition, buffering capacity, and pH, catering to specific clinical or research needs.

5. What are future trends influencing the Balanced Salt Solution supply market?
Increasing demand for personalized formulations, digital traceability, manufacturing diversification, and supply chain resilience are shaping the industry's outlook.

References
[1] Global Pharmaceutical Solutions Market Analysis. (2022). Data Bridge Market Research.
[2] ISO Standards and Certifications for Biopharmaceutical Manufacturing. International Organization for Standardization, 2021.
[3] FDA Guidance for Sterile Drug Products. U.S. Food and Drug Administration, 2022.
[4] Company websites and product catalogs: B. Braun, Baxter, Fresenius Kabi, Geo-Science, Roar Biomedical.