Suppliers and packagers for AQUASOL A

AQUASOL A

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Casper Pharma Llc	AQUASOL A	vitamin a palmitate	INJECTABLE;INJECTION	006823	NDA	Casper Pharma LLC	70199-026-11	1 VIAL, SINGLE-DOSE in 1 CARTON (70199-026-11) / 2 mL in 1 VIAL, SINGLE-DOSE	2020-10-01

Suppliers for the Pharmaceutical Drug: AQUASOL A

Last updated: July 30, 2025

Introduction

AQUASOL A is a specialized pharmaceutical drug used primarily for the treatment of hypocalcemia, osteoporosis, and other calcium deficiency-related conditions. Its formulation typically involves high-purity calcium gluconate or calcium chloride, delivered in a manner suitable for intravenous infusion or oral administration, depending on the indication. In the highly regulated pharmaceutical industry, securing reliable suppliers for AQUASOL A involves navigating complex supply chains, compliance standards, and regulatory approvals. This article offers a comprehensive overview of key suppliers, sourcing strategies, and considerations for pharmaceutical manufacturers and distributors seeking AQUASOL A.

Overview of AQUASOL A and Its Market Demand

AQUASOL A has gained validation globally as an essential electrolyte replenisher, especially within acute care settings. Its demand is driven by hospitals, clinics, and healthcare providers managing calcium deficiencies associated with chronic diseases, post-surgical care, or chemotherapy treatments. The increasing prevalence of osteoporosis and age-related calcium depletion further amplifies the need for high-quality supply chain channels.

Global market estimates for calcium infusion solutions, including AQUASOL A, project CAGR rates of approximately 5-7% over the next five years, with Asia-Pacific and North America as primary growth regions. Consequently, establishing partnerships with top-tier suppliers is vital for market competitiveness.

Leading Suppliers and Manufacturers of AQUASOL A

1. Fresenius Kabi

Fresenius Kabi is a dominant player in the global infusion solutions market. Their portfolio includes prefilled calcium infusion products akin to AQUASOL A. Known for stringent quality control, compliance with Good Manufacturing Practices (GMP), and extensive distribution networks, Fresenius Kabi supplies directly to hospitals and distributors worldwide.

• Product Highlights:
  • Calcium chloride and calcium gluconate infusion solutions.
  • ISO-certified manufacturing facilities.
• Strengths:
  • Broad global footprint.
  • Established regulatory approvals, including FDA and EMA.

2. Baxter International

Baxter is a reputed manufacturer of intravenous medications, including calcium-based solutions. Their fluid and electrolyte products meet rigorous safety standards and are widely endorsed for clinical use.

• Product Highlights:
  • Baxter's calcium solutions are available in multiple strengths and formulations.
  • Extensive research and development backing their products.
• Strengths:
  • Global supply chain.
  • Strong distribution channels, especially in North America and Europe.

3. B. Braun Melsungen AG

B. Braun manufactures a range of injectable solutions, including calcium chloride and calcium gluconate formulations suitable for AQUASOL A-like applications. Their focus on innovation, quality, and sustainability makes them a preferred supplier.

• Product Highlights:
  • Customized intravenous calcium solutions.
  • Stringent validation processes.
• Strengths:
  • Extensive presence in Europe and emerging markets.
  • History of regulatory compliance and product safety.

4. Hospira (a Pfizer company)

Hospira is known for its extensive portfolio of infusion therapies, including calcium solutions. Their manufacturing facilities adhere to high GMP standards, ensuring consistent product quality.

• Product Highlights:
  • Calcium chlorides and gluconates.
  • Ready-to-use infusion bags.
• Strengths:
  • Integration with Pfizer enhances global distribution.
  • Strong focus on compliance and quality assurance.

5. Local and Regional Manufacturers

Apart from global giants, regional pharmaceutical companies—particularly those in India, China, and Eastern Europe—manufacture calcium infusion solutions under strict regulatory standards. These suppliers often offer competitive pricing and tailored formulations, making them attractive for certain markets.

• Examples:
  • Shandong Yuhong Pharmaceutical Co. (China)
  • Biopharma Ltd. (India)
  • Farmabios (Italy)

Note: For clinical and regulatory approval, verifying the GMP certification and quality control mechanisms of regional suppliers is crucial.

Sourcing Strategies for AQUASOL A

Regulatory Considerations

Secure supply chains must comply with international standards such as FDA (USA), EMA (Europe), and PMDA (Japan). Suppliers should possess valid GMP certifications, batch traceability documentation, and adherence to cGMP requirements.

Quality Assurance

Due diligence involves auditing manufacturing facilities, verifying stability data, and inspecting validation records. Cold chain management is often crucial due to the temperature-sensitive nature of infusion solutions.

Pricing and Contract Negotiations

Cost competitiveness depends on production volume, supplier location, and logistics efficiency. Establishing long-term contracts with fixed or tiered pricing models helps ensure consistent supply and price stability.

Distributors and Importers

Many pharmaceutical companies work with third-party distributors who specialize in sterile injectable solutions. Choosing reputable distributors with proven regulatory compliance reduces supply chain risks.

Navigating Patent and Licensing Challenges

While AQUASOL A formulations are often off-patent, proprietary delivery systems or unique formulations may be patent-protected. Engaging with patent holders or licensing agencies can facilitate technology transfer or licensed manufacturing.

Global Regulatory Landscape

The regulatory landscape influences supplier selection. For example:

• United States: Requires FDA approval or clearance, with documentation verifying sterile manufacturing and absence of pyrogens.
• European Union: European Medicines Agency (EMA) compliance with active substance specifications.
• Emerging Regions: Local registration processes may require additional documentation, such as stability testing under regional climatic conditions.

Understanding these requirements ensures seamless import and distribution operations.

Challenges and Risk Mitigation

• Supply Disruptions: Mitigate through diversified sourcing across multiple suppliers and regions.
• Quality Variability: Implement rigorous qualification and audits.
• Regulatory Delays: Work closely with regulatory consultants to expedite registration processes.
• Price Volatility: Enter fixed-term agreements and explore regional manufacturing alliances.

Conclusion

The supply chain for AQUASOL A is characterized by a select group of global and regional manufacturers with established GMP standards. Leading firms like Fresenius Kabi, Baxter, B. Braun, and Hospira stand out as primary suppliers due to their extensive production capacities and compliance frameworks. Sourcing involves meticulous due diligence, regulatory adherence, and strategic negotiation to ensure quality, cost-effectiveness, and supply continuity. Securing reliable partners in this domain is vital for manufacturers, healthcare providers, and distributors aiming to meet market demand effectively.

Key Takeaways

• Global Giants Dominate: Major multinational manufacturers are primary sources for AQUASOL A, offering extensive regulatory approval and supply reliability.
• Regulatory Compliance is Critical: Suppliers must meet stringent GMP standards; verifying certifications is essential.
• Diversification Is Risk-Reducing: Relying on multiple suppliers mitigates risks of disruption.
• Regional Manufacturers Offer Cost Advantages: Local suppliers can provide competitively priced options but require thorough validation.
• Strategic Sourcing Enhances Business Stability: Long-term contracts, regulatory vetting, and quality audits are fundamental to building a resilient supply chain.

FAQs

Q1: What are the primary forms of AQUASOL A available in the market?
A1: AQUASOL A typically refers to calcium infusion solutions available as calcium chloride or calcium gluconate in prefilled bags, ready for intravenous administration.

Q2: Which countries are leading producers of AQUASOL A or its equivalents?
A2: The United States (via companies like Baxter and Hospira), Germany (B. Braun), and other European countries dominate production, with regional manufacturers in China, India, and Eastern Europe supplementing supplies.

Q3: What certifications should I verify when sourcing AQUASOL A?
A3: Verify GMP certification, FDA approval or clearance, ISO certifications, and any regional compliance standards relevant to your jurisdiction.

Q4: How can I reduce risks associated with supply chain disruptions?
A4: Build relationships with multiple suppliers across different regions, establish long-term contracts, and maintain adequate inventory buffers.

Q5: Are regional manufacturers in emerging markets considered reliable for AQUASOL A?
A5: They can be, provided they possess valid GMP certifications, transparent quality control processes, and meet international regulatory standards. Due diligence and audits are recommended before engagement.

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Sources

1. Fresenius Kabi Product Portfolio [1]
2. Baxter International Product Data [2]
3. B. Braun Quality Standards [3]
4. Hospira (Pfizer) IV Solutions [4]
5. Regulatory Guidelines for Sterile Injectable Products [5]