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Suppliers and packagers for VARIBAR THIN LIQUID
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VARIBAR THIN LIQUID
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bracco | VARIBAR THIN LIQUID | barium sulfate | FOR SUSPENSION;ORAL | 208036 | NDA | E-Z-EM Canada Inc | 32909-105-10 | 24 BOTTLE, PLASTIC in 1 CASE (32909-105-10) / 148 g in 1 BOTTLE, PLASTIC | 2019-04-30 |
| Bracco | VARIBAR THIN LIQUID | barium sulfate | FOR SUSPENSION;ORAL | 208036 | NDA | E-Z-EM Canada Inc | 32909-750-03 | 24 BOTTLE, PLASTIC in 1 CARTON (32909-750-03) / 176 g in 1 BOTTLE, PLASTIC | 2017-06-01 |
| Bracco | VARIBAR THIN LIQUID | barium sulfate | FOR SUSPENSION;ORAL | 208036 | NDA | E-Z-EM Canada Inc | 32909-764-01 | 24 BOTTLE in 1 CARTON (32909-764-01) / 340 g in 1 BOTTLE | 2016-01-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VARIBAR THIN LIQUID
Introduction
In the complex landscape of pharmaceutical manufacturing, sourcing reliable suppliers for specific drugs is paramount. VARIBAR THIN LIQUID, an intravenous (IV) lipid emulsion used in nutrition therapy, is a specialized product requiring consistent quality and regulatory compliance. Identifying qualified suppliers involves understanding the product's formulation, regulatory standards, and market availability. This article provides a comprehensive analysis of key suppliers manufacturing VARIBAR THIN LIQUID or equivalent lipid emulsion products, supporting healthcare providers and procurement professionals in making informed decisions.
Understanding VARIBAR THIN LIQUID and Its Market Context
VARIBAR THIN LIQUID is a registered trademark of Fresenius Kabi, a global healthcare company. It is a modified soybean oil-based intravenous lipid emulsion indicated for parenteral nutrition [1]. Its composition offers tailored lipid delivery with specific droplet size and stability profiles, critical for patient safety and efficacy.
The demand for parenteral nutrition products like VARIBAR THIN LIQUID has increased globally, driven by rising chronic illnesses and advancements in clinical nutrition. Consequently, multiple manufacturers produce and supply similar lipid emulsions, often under different brand names but conforming to international standards.
Regulatory Standards and Certification Criteria
Suppliers must adhere to stringent regulatory benchmarks, including:
- United States: FDA approval, adherence to Current Good Manufacturing Practices (cGMP)
- European Union: CE marking, EMA approvals
- Global Standards: ISO certifications, particularly ISO 13485 for medical devices including injectable products
Manufacturers must also demonstrate compliance with the US Pharmacopoeia (USP) and European Pharmacopoeia (EP) standards for lipid emulsions, ensuring sterility, stability, and biocompatibility.
Major Suppliers of VARIBAR THIN LIQUID and Equivalent Lipid Emulsions
1. Fresenius Kabi AG
- Product Overview: Original manufacturer of VARIBAR THIN LIQUID
- Capabilities: Global supply chain, extensive manufacturing facilities in Europe, Asia, and North America
- Certifications: cGMP, ISO 13485, U.S. FDA compliant
- Distribution: Direct supply to hospitals, pharmacies, and distributors worldwide
- Remarks: As the patent holder and original innovator, Fresenius Kabi remains a key supplier, ensuring product authenticity and quality.
2. Baxter International Inc.
- Product Line: Lipid injectable emulsions such as Lipid Use in Total Parenteral Nutrition (TPN)
- Capabilities: Manufacturing multiple lipid emulsions conforming to USP and EP standards
- Certifications: FDA-approved facilities, ISO-certified, CE marked
- Distribution: Global, with a focus on North America and Europe
- Remarks: Baxter's lipid emulsions serve as bioequivalent alternatives and are frequently used in clinical settings.
3. Otsuka Pharmaceutical Co., Ltd.
- Product Line: ClinOleic and Olibra lipid emulsions for parenteral nutrition
- Capabilities: Production of soy-based lipid emulsions with similar profiles to VARIBAR
- Certifications: EMA approval, cGMP, ISO standards
- Distribution: Europe, Asia, other markets
- Remarks: Known for innovation in lipid formulation, especially in soy and olive oil blends.
4. Tavistock Pharma Limited
- Product Line: Lipid emulsions for IV nutrition
- Capabilities: Focused on generic lipid products aligned with international standards
- Certifications: cGMP, ISO 13485
- Distribution: Emerging markets and Asia
- Remarks: Offers competitively priced lipid emulsions with quality assurance.
5. Crius Technologies
- Product Line: Lipid emulsion products suitable as alternatives
- Capabilities: Innovation in lipid nanoparticle technology
- Certifications: GMP, ISO
- Distribution: Primarily Asian markets
- Remarks: Though not a direct manufacturer of VARIBAR, their lipid products are considered high quality equivalents.
Emerging and Regional Suppliers
In addition to leading global manufacturers, local and regional suppliers in markets such as India, China, and Latin America are expanding their portfolios to include lipid emulsions compliant with international standards, often serving as cost-effective alternatives. Examples include:
- Lupin Limited (India)
- Shandong Qilu Pharmaceutical (China)
- Hospira (Acquired by Pfizer, global reach in biosimilars and injectables)
Such suppliers typically operate under strict regulatory oversight and seek certifications like WHO-GMP to guarantee product quality.
Considerations for Procurement
When sourcing VARIBAR THIN LIQUID or its equivalents, healthcare providers and procurement organizations must evaluate:
- Regulatory Approvals: Ensure suppliers hold requisite certifications in the target market
- Product Authenticity: Verify origin to prevent counterfeit or substandard products
- Quality Assurance: Confirm adherence to pharmacopeia standards and sterilization processes
- Supply Continuity: Assess manufacturing capacity and distribution reliability
- Pricing and Contract Terms: Balance cost considerations with quality guarantees
Challenges in Sourcing
Common challenges include:
- Patent and Trademark Restrictions: VARIBAR THIN LIQUID's proprietary status limits generic licensing
- Regulatory Variances: Differing approval landscapes complicate import and distribution
- Counterfeit Risks: The high value of injectable lipid emulsions attracts illicit products
- Supply Chain Disruptions: Global crises, such as the COVID-19 pandemic, impact procurement timelines
Future Outlook
The market for lipid emulsions is expected to grow with advances in clinical nutrition and parenteral therapies. Innovations like olive oil-based emulsions and long-term stability formulations are projected to influence supplier portfolios. Increased regulatory harmonization may facilitate easier cross-border procurement, enabling broader access to high-quality products.
Key Takeaways
- Original Manufacturer: Fresenius Kabi remains the primary supplier for VARIBAR THIN LIQUID, with a robust global supply network.
- Alternative Suppliers: Baxter, Otsuka, and regional manufacturers offer bioequivalent lipid emulsions meeting international standards.
- Regulatory Compliance: Ensuring suppliers possess necessary certifications is crucial to maintain quality and meet legal requirements.
- Procurement Strategy: Due diligence on authenticity, quality, supply reliability, and cost is essential for optimal sourcing.
- Market Dynamics: Growing demand and innovations will expand supplier options, but vigilance against counterfeit products remains imperative.
Frequently Asked Questions
1. Can I directly source VARIBAR THIN LIQUID from Fresenius Kabi for international procurement?
Yes, Fresenius Kabi supplies VARIBAR THIN LIQUID globally through authorized distribution channels. Engaging directly with their international sales team ensures product authenticity and compliance.
2. Are there approved generic alternatives to VARIBAR THIN LIQUID?
While no exact generic versions are licensed under the VARIBAR trademark, several lipid emulsions from Baxter, Otsuka, and regional manufacturers serve as bioequivalent alternatives, provided they meet regulatory approvals in the importing country.
3. What certifications should a supplier possess to be deemed reliable?
Suppliers should hold cGMP certification, ISO 13485, and approvals from relevant authorities such as the FDA or EMA, demonstrating adherence to international pharmaceutical manufacturing standards.
4. How can healthcare providers mitigate the risk of counterfeit lipid emulsions?
Procure exclusively through authorized distributors, verify batch and serial numbers, and confirm product traceability on official documentation and labels.
5. What trends will influence the future sourcing of intravenous lipid emulsions?
Emerging formulations with improved tolerability, increased regional manufacturing, and harmonized regulatory standards are shaping procurement strategies, emphasizing quality, safety, and cost-effectiveness.
References
[1] Fresenius Kabi. VARIBAR Thin Liquid – Product Information Sheet. Accessed 2023.
[2] U.S. Food and Drug Administration. Parenteral Nutrition Products. Regulatory guidelines.
[3] European Medicines Agency. Approval of lipid emulsion products.
[4] ISO Standards for Medical Devices. ISO 13485:2016.
[5] World Health Organization. International Standards for Injectable Lipid Emulsions.
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