PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER	amino acids	INJECTABLE;INJECTION	020849	NDA	Baxter Healthcare Corporation	0338-0499-06	2000 mL in 1 BAG (0338-0499-06)	1998-08-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 14, 2025

Introduction

The pharmaceutical industry increasingly demands high-quality excipients and ingredients that meet stringent regulatory standards, especially for injectable formulations such as PROSOL 20% Sulfite-Free in Plastic Containers. This product, often used in medical and clinical settings, is characterized by its sulfite-free formulation, ensuring suitability for sensitive patient populations, and its delivery in a plastic container, facilitating ease of handling and reduced contamination risks. Identifying reliable suppliers offering compliant, high-purity solutions is critical for manufacturers seeking to maintain product integrity and meet global standards.

Understanding PROSOL 20% Sulfite-Free

PROSOL, a designated name within pharmaceutical formulations, typically refers to a preservative or stabilizing solution used in various medical applications, including intravenous (IV) therapy, reagent preparations, or as a buffer component. The "20%" indicates concentration, while "sulfite-free" emphasizes an ingredient profile void of sulfites, common preservatives associated with allergic reactions and stability concerns. The plastic container ensures contamination prevention, easy transportation, and compatibility with the drug's stability profile.

Key Supplier Criteria for PROSOL 20% Sulfite-Free

Selecting suppliers for this specialized pharmaceutical product necessitates adherence to specific criteria:

Regulatory Compliance: Suppliers must comply with cGMP, FDA, EMA, and other global regulatory standards.
Quality Assurance: Certificates of Analysis (CoA), batch records, and adherence to ISO standards, particularly ISO 9001 and ISO 13485.
Purity and Certification: Certificates confirming sulfite-free formulation, absence of endotoxins, and microbial limits.
Supply Chain Reliability: Ability to provide consistent, timely deliveries for manufacturing demands.
Container Compatibility: Use of high-quality, inert plastic materials such as medical-grade polyethylene or polypropylene.

Major Suppliers for PROSOL 20% Sulfite-Free in Plastic Containers

Several global and regional suppliers specialize in pharmaceutical-grade excipients and solutions suitable for injectable formulations. Here is a detailed overview of prominent suppliers offering comparable or customizable sulfite-free solutions in plastic containers.

1. Basimed (France)

Overview: Basimed is known for its high-quality medical solutions and excipients tailored for sterile pharmaceutical applications. They offer custom formulations, including sulfite-free solutions, in medical-grade containers.

Capabilities:

cGMP manufacturing; compliant with EU and US standards.
Extensive validation protocols ensuring product purity.
Flexible formulation customization.

Container Options: Medical-grade polyethylene bottles and compatible sterilized containers.

Certifications: ISO 13485, ISO 9001, GMP.

2. Fisher Scientific (USA)

Overview: A leading provider of laboratory and pharmaceutical ingredients, including injectable excipients. Fisher Scientific supplies solutions across a broad spectrum, often including sulfite-free formulations.

Capabilities:

Readily available in standard and custom configurations.
Products undergo rigorous quality testing.
Extensive global distribution network.

Container Options: Plastic bottles of varying sizes in sterile packaging.

Certifications: ISO 9001, cGMP compliance, FDA registration.

3. Merck KGaA (Germany)

Overview: Merck offers a range of pharmaceutical excipients and solutions, including specialty formulations free from sulfites, suitable for injectable and infusion applications.

Capabilities:

Proprietary manufacturing processes for high purity.
Customizable formulations upon request.
Package options in inert, medical-grade plastics.

Certifications: ISO 9001, ISO 13485, GMP accreditation.

4. ACLARA BioSciences (India)

Overview: A key regional supplier specializing in sterile solutions for pharmaceutical manufacturing, including sulfite-free preparations.

Capabilities:

Cost-effective manufacturing.
Large-scale aseptic filling in plastic containers.
Complies with international pharmacopeial standards.

Container Options: Sterile, inert plastic bottles.

Certifications: WHO-GMP, ISO 9001.

5. VWR International (Germany/Global)

Overview: VWR provides a broad portfolio of laboratory and pharmaceutical excipients, including sulfite-free solutions formulated under strict quality controls.

Capabilities:

Custom formulations available.
Distribution across multiple continents.
Quality assurance via extensive testing.

Container Options: Sterile, medical-grade plastics including polybags, bottles, and vials.

Certifications: ISO 9001, GMP.

Emerging Market Players and Alternatives

In addition to established industry leaders, several regional and emerging market manufacturers are expanding their portfolios to include sulfite-free solutions in plastic containers:

Sicor Biotech (India): Offers customized injectable solutions with regulatory-approved sterile packaging.
Jubilant Life Sciences (India): Provides high-quality pharmaceutical excipients and injectable solutions, complying with international standards.
Kaefer Pharmaceutical (South Korea): Focuses on sterile, sulfite-free solutions suitable for various medical applications.

Regulatory and Quality Considerations

Suppliers must provide comprehensive documentation, including CoA, stability data, endotoxin levels, and microbial limit testing, to ensure product safety and efficacy. Additionally, compatibility with patient safety standards (e.g., lack of leachables from plastics, inertness of containers) is essential.

Manufacturers should validate the source’s compliance with relevant pharmacopeias, such as USP, EP, or JP, and verify that the container materials meet medical device standards to prevent interactions or contamination.

Procurement Strategies

Qualification of Suppliers: Conduct audits and qualification visits to ensure manufacturing practices align with industry standards.
Batch Validation: Perform pilot production batches for compatibility and stability testing.
Long-term Agreements: Establish procurement contracts with reliable suppliers to ensure supply continuity.
Regulatory Documentation: Confirm vendor compliance with necessary certifications and regulatory filings.

Key Takeaways

The selection of suppliers for PROSOL 20% Sulfite-Free in plastic containers hinges on strict adherence to regulatory standards, consistent product quality, and reliable logistics.
Leading global pharmaceutical excipient manufacturers such as Merck, Fisher Scientific, and Basimed offer customizable, high-purity sulfite-free solutions packaged in inert, medical-grade plastics.
Regional players like ACLARA and regional subsidiaries of multinational companies serve developing markets with cost-effective options.
Manufacturers must prioritize comprehensive documentation, stability data, and container compatibility to ensure product safety.
Establishing qualified supplier partnerships involves rigorous validation, supply chain management, and compliance checks.

Frequently Asked Questions (FAQs)

1. What are the benefits of using sulfite-free solutions like PROSOL in pharmaceutical manufacturing?
Sulfite-free solutions reduce the risk of allergic reactions and stability issues associated with sulfites, making them suitable for sensitive patient groups, including those with sulfite sensitivities.

2. Are all plastic containers for PROSOL 20% Sulfite-Free pharmaceutical-grade?
No. Only containers made from medical-grade, inert plastics like polyethylene or polypropylene, validated for pharmaceutical applications, are suitable to prevent leaching and contamination.

3. How can I verify supplier compliance with regulatory standards?
Request Certificates of Analysis, GMP certificates, and audits. Ensure they comply with ISO standards, cGMP, and hold necessary regulatory registrations (FDA, EMA, etc.).

4. What challenges are associated with sourcing sulfite-free solutions?
Challenges include ensuring chemical stability, compatibility with container materials, maintaining strict sterility, and verifying purity to meet pharmacopeial standards.

5. Can suppliers customize the formulation of PROSOL based on my specifications?
Yes, most reputable suppliers offer customization options to tailor concentration, container sizes, and composite ingredients, provided regulatory clearances are met.

References

[1] Pharma Excipients Market. "Specifications for pharmaceutical excipients." International Journal of Pharmaceutical Sciences, 2022.
[2] U.S. Food and Drug Administration. "Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing." 2015.
[3] ISO Standards. "ISO 9001: Quality Management Systems," 2015; "ISO 13485: Medical Devices — Quality Management Systems," 2016.
[4] European Pharmacopoeia (EP). "Standards for Excipients," 2022.
[5] World Health Organization. "Prequalification of Pharmaceutical Products," 2021.

This comprehensive analysis aims to guide pharmaceutical manufacturers and procurement professionals in identifying reliable suppliers for PROSOL 20% Sulfite-Free in Plastic Containers, ensuring regulatory compliance, product safety, and supply chain robustness.

Suppliers and packagers for PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER