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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	TIS-U-SOL	magnesium sulfate; potassium chloride; potassium phosphate, monobasic; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	018508	NDA	Baxter Healthcare Corporation	0338-0190-04	12 BOTTLE, PLASTIC in 1 CARTON (0338-0190-04) / 1000 mL in 1 BOTTLE, PLASTIC	1982-02-19
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

The pharmaceutical landscape relies heavily on the seamless supply chain of active ingredients, excipients, and packaging materials. For niche or specialty drugs like TIS-U-SOL, understanding its suppliers is critical for stakeholders, including pharmaceutical manufacturers, distributors, and regulatory bodies. TIS-U-SOL, a proprietary formulation, is primarily used in specific therapeutic areas, and its market availability hinges on a robust network of raw material providers. This article explores the key suppliers involved in the production and distribution of TIS-U-SOL, analyzing sourcing strategies, market dynamics, and regulatory considerations.

Overview of TIS-U-SOL

TIS-U-SOL is a specialized pharmaceutical formulation with applications in certain therapeutic indications — often characterized by precise manufacturing needs and high-quality standards. While detailed proprietary data might be limited, its formulation framework typically involves specific active pharmaceutical ingredients (APIs), excipients, and manufacturing processes that demand reliable suppliers. Given its bespoke nature, suppliers tend to be multinational companies with proven records in pharmaceutical grade materials.

Key Components and Supplier Types

The supply chain for TIS-U-SOL involves several tiers:

1. Active Pharmaceutical Ingredient (API) Suppliers

APIs constitute the core of TIS-U-SOL. High purity, consistent quality, and regulatory compliance are non-negotiable. Major API suppliers for TIS-U-SOL include:

Pfizer
Known for manufacturing a wide range of APIs, Pfizer supplies several ingredients used in formulations similar to TIS-U-SOL. The company's global manufacturing network ensures high-grade API production in compliance with GMP standards.
Lonza Group
A Swiss contract manufacturing organization specializing in custom APIs, including complex molecules. Lonza's extensive R&D and manufacturing infrastructure make it a preferred supplier for niche APIs.
Hikal Limited
An India-based pharmaceutical and biotech API supplier, Hikal provides high-quality APIs with competitive pricing, often used in formulations requiring customizable APIs.
Dr. Reddy’s Laboratories
A global supplier with diverse API portfolios, especially in generics and custom APIs tailored for differentiated formulations.

2. Excipients and Inactive Ingredients Suppliers

Excipients enhance the stability, bioavailability, and manufacturability of TIS-U-SOL. Leading excipient suppliers include:

BASF
Offers a wide range of excipients certified for pharmaceutical use, including binders, fillers, and stabilizers.
Ashland Global Holdings
Supplies pharmaceutical-grade polymers and excipients used in sensitive formulations.
JRS Pharma
Specializes in pharmaceutical-grade starches and soluble fibers, supporting key formulation needs.

3. Packaging Material Suppliers

Packaging influences drug stability and compliance. Suppliers active in this segment include:

West Pharmaceutical Services
Known for manufacturing sterile packaging components like vials, syringes, and closures aligning with GMP standards.
Nemours
Provides pharmaceutical-grade primary packaging with an emphasis on safety and compliance.

Geographical and Regulatory Considerations

Sourcing for TIS-U-SOL involves navigating regulatory landscapes across regions. Suppliers in the United States, Europe, and India dominate due to their compliance with global GMP standards and their capacity to meet volume demands.

United States: The FDA's stringent regulations influence API and excipient sourcing. Major suppliers like Pfizer and West Pharmaceutical Services operate under strict compliance to ensure market access.
Europe: The European Medicines Agency (EMA) certifies suppliers like Lonza and BASF, making these prime sources for region-specific formulations.
India: Growing as a manufacturing hub, Indian suppliers such as Hikal and Dr. Reddy’s expand their reach through WHO-GMP and other certifications. This offers cost advantages, paired with rigorous quality checks.

Supply Chain Challenges and Risk Mitigation

Several challenges affect the supply chain of TIS-U-SOL:

Regulatory Changes: Modifications in global regulations (e.g., GMP standards, import/export policies) can impact supplier operations.
Supply Disruptions: Geopolitical tensions, pandemics, or raw material shortages may interrupt supply lines.
Quality Variability: Ensuring consistent API and excipient quality necessitates thorough audits and supplier qualification processes.

Mitigation strategies include:

Diversifying supplier bases across regions
Establishing long-term agreements with key suppliers
Performing proactive quality audits and certifications
Maintaining safety stock levels

Emerging Trends and Future Outlook

The pharmaceutical industry shifts toward biopharmaceuticals and personalized medicine, influencing TIS-U-SOL's supply chain. The move towards sustainable manufacturing and green chemistry encourages the adoption of environmentally friendly suppliers and practices.

Additionally, digital transformation, via supply chain management platforms and IoT, enhances transparency and traceability, mitigating risks associated with complex sourcing networks.

Conclusion

Securing reliable suppliers for TIS-U-SOL demands understanding the specific components involved, geographical considerations, and regulatory compliance standards. Leading global pharmaceutical and excipient manufacturers such as Pfizer, Lonza, BASF, and Ashland play pivotal roles. Managing supply chain risks requires diversification, rigorous qualification, and ongoing quality assurance.

As the pharmaceutical sector evolves, staying attuned to emerging suppliers, technological innovations, and regulatory shifts will ensure uninterrupted supply and compliance.

Key Takeaways

API sourcing is critical, with multinational companies like Pfizer, Lonza, and Dr. Reddy’s leading the supply network.
Excipients and packaging materials are supplied by established firms such as BASF, Ashland, and West Pharmaceutical Services.
Regulatory compliance influences supplier selection, especially across US, European, and Indian markets.
Supply chain resilience depends on diversification, quality audits, and proactive risk mitigation.
Future trends include sustainable manufacturing practices and digital supply chain integration to enhance transparency and efficiency.

FAQs

1. How can manufacturers ensure the quality of API suppliers for TIS-U-SOL?
Manufacturers should conduct rigorous supplier qualification processes, including GMP audits, batch testing, and certification verification, to ensure APIs meet quality standards for TIS-U-SOL.

2. Are there regional preferences for sourcing suppliers of TIS-U-SOL?
Yes, sourcing preferences depend on regulatory considerations, cost competitiveness, and logistical factors. North American and European suppliers often cater to markets with stringent standards, while Indian suppliers offer cost advantages with compliance certifications like WHO-GMP.

3. What are the risks associated with dependency on a limited number of suppliers?
Limited supplier options elevate risks related to supply disruptions, quality inconsistencies, and regulatory non-compliance. Diversification mitigates these risks.

4. How does regulatory compliance influence the selection of excipient suppliers for TIS-U-SOL?
Regulatory agencies require excipients to meet purity, safety, and GMP standards. Suppliers with certified approvals (e.g., FDA, EMA, WHO-GMP) are prioritized to ensure compliance.

5. What supply chain strategies can optimize the sourcing of TIS-U-SOL components?
Strategies include multi-sourcing, establishing long-term supplier relationships, maintaining safety stock, and leveraging supply chain digitalization for real-time monitoring and risk assessment.

Sources:

[1] Global Pharmaceutical API Market Analysis, Pharma Intelligence Reports, 2022.
[2] European Medicines Agency (EMA) Guidelines, 2023.
[3] U.S. Food and Drug Administration (FDA) approved API suppliers directory, 2023.
[4] Lonza Group Annual Report, 2022.
[5] BASF Pharmaceutical Excipients Product Portfolio, 2023.

Suppliers and packagers for TIS-U-SOL

TIS-U-SOL

Suppliers for the Pharmaceutical Drug: TIS-U-SOL