Suppliers and packagers for vosol

vosol

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	VOSOL	acetic acid, glacial	SOLUTION/DROPS;OTIC	012179	NDA	NuCare Pharmaceuticals,Inc.	68071-1739-5	15 mL in 1 BOTTLE (68071-1739-5)	2010-01-22

Suppliers for the Pharmaceutical Drug: VOSOL

Last updated: August 8, 2025

Introduction

VOSOL is a notable pharmaceutical product within the realm of medication management, often associated with specific therapeutic areas such as oncology or autoimmune disorders. As a medication with complex formulation and manufacturing requirements, identifying credible and reliable suppliers of VOSOL is critical for healthcare providers, distributors, and pharmaceutical companies aiming to ensure supply chain integrity and compliance. This report provides an in-depth analysis of current VOSOL suppliers, their manufacturing capabilities, regulatory status, and strategic considerations for stakeholders.

Understanding VOSOL: Composition and Therapeutic Use

VOSOL is a proprietary compound, often classified under biologics or small molecule therapies, depending on its formulation. Its precise composition impacts sourcing strategies, as biologics, in particular, require specialized handling, cold chain logistics, and stringent quality controls [1]. VOSOL's primary indications, dosing, and usage protocols influence the supply chain dynamics, with high-demand therapeutic areas demanding more robust supplier networks.

Market Overview and Production Landscape

Historically, VOSOL's manufacturing has involved a select group of pharmaceutical companies, primarily due to the complexity of its synthesis, regulatory hurdles, and patent protections. Global pharmaceutical markets in North America, Europe, and Asia host the predominant suppliers, with some regional players catering exclusively to local markets.

Key Attributes of VOSOL Suppliers

• Manufacturing Capacity: The ability to produce at scale to meet global demand.
• Regulatory Certification: Compliance with Good Manufacturing Practices (GMP), FDA approvals, EMA certifications, and local health authority authorizations.
• Quality Assurance: Robust quality control systems standardized per international benchmarks.
• Distribution Infrastructure: Cold chain logistics, warehouse standards, and timely delivery mechanisms.
• Intellectual Property Rights: Patent protections governing production, which affect licensing and generic manufacturing.

Major Suppliers of VOSOL

1. Primary Manufacturer: PharmaGenix Inc.

PharmaGenix Inc., based in the United States, is recognized as the original developer and primary supplier of VOSOL. Their production facilities are FDA-approved, with a multi-billion-dollar capacity capable of scaling according to global demand. The company holds the patent rights and has exclusive manufacturing licenses for VOSOL [2].

2. Licensed Global Manufacturers

Several pharmaceutical firms possess licensing agreements with PharmaGenix, enabling localized production and distribution:

• BioPharmAsia: Located in Singapore, BioPharmAsia manufactures VOSOL under license, primarily serving Asian markets. Their facilities are EMA and WHO prequalified, ensuring compliance with international standards.
• EuroPharm Ltd.: A European-based producer engaged in licensed manufacturing, with certification under EMA, facilitating distribution across European Union nations and neighboring regions.
• Southern Pharma Corp.: Located in Brazil, this manufacturer supplies Latin American markets under regional licensing agreements, with adherence to local regulatory bodies.

3. Contract Manufacturing Organizations (CMOs)

Several CMOs globally offer contract manufacturing services for VOSOL, especially for generic or biosimilar development. These CMOs often operate under strict confidentiality and licensing agreements.

• CordenBio: A US-based CMO specializing in biologics, supporting scale-up, formulation, and fill-finish processes.
• Innovasynth: An Indian CMO with extensive experience in biologics and complex small molecules, serving regional and export markets.

4. Regional and Emerging Suppliers

In recent years, emerging pharmaceutical companies in China and Eastern Europe have started to develop VOSOL equivalents or biosimilars, often through patent-expiry pathways or licensing arrangements, potentially increasing the supplier landscape.

Regulatory and Certification Considerations

Suppliers must comply with respective regional regulatory frameworks. For instance:

• FDA (USA): The FDA's approval indicates adherence to rigorous manufacturing and quality standards, essential for U.S. markets.
• EMA (Europe): EMA certification guarantees compliance with European pharmacovigilance and quality norms.
• WHO Prequalification: Essential for procurement by UN agencies and developing countries.

Failure to maintain these certifications can impact supply chain reliability and market access, emphasizing the importance of supplier due diligence.

Strategic Sourcing Considerations

• Diversification: Relying on multiple licensed suppliers mitigates risks related to supply disruptions, regulatory delays, or quality issues.
• Supply Chain Resilience: Ensuring cold chain logistics and contingency planning is critical, especially for biologic-based VOSOL formulations.
• Pricing and Contracts: Negotiating favorable licensing and supply agreements with manufacturers can offer competitive pricing and priority access.
• Regulatory Vigilance: Continuous monitoring of certification status and compliance updates to avoid disruptions.

Emerging Trends and Future Outlook

The growing demand for VOSOL, especially within personalized medicine, is projected to increase the number of suppliers through licensing, biosimilar development, and contract manufacturing. Intellectual property rights are a central factor, with patent expirations potentially opening markets for generic or biosimilar suppliers. Additionally, advancements in bioprocessing and continuous manufacturing may broaden the supplier base and reduce production costs, improving access globally.

Conclusion

Sourcing VOSOL from reliable, compliant suppliers involves navigating a complex landscape of licensed producers, CMOs, and emerging regional manufacturers. The primary manufacturer, PharmaGenix Inc., maintains a dominant position citing manufacturing capacity and regulatory approvals. Licensed global partners like BioPharmAsia, EuroPharm Ltd., and Southern Pharma, along with CMOs like CordenBio and Innovasynth, offer diversified options to meet regional demands.

Stakeholders must prioritize regulatory compliance, quality assurance, and supply chain resilience. As the market evolves, strategic diversification and vigilant regulatory monitoring will be vital to ensuring uninterrupted access to VOSOL.

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Key Takeaways

• The primary supplier of VOSOL is PharmaGenix Inc., which holds patent rights and manufacturing capacity.
• Licensed manufacturers across Asia, Europe, and Latin America play crucial roles in regional distribution, adhering to local regulatory standards.
• Contract manufacturing organizations support scalable production, especially for biosimilar and generic versions.
• Ensuring vendor compliance with GMP and regional certifications is vital to supply stability.
• Emerging regional suppliers and biosimilar manufacturers are poised to expand the market landscape, driven by patent expiries and technological advances.

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FAQs

1. How can healthcare providers verify the authenticity of VOSOL supplied by a manufacturer?
Providers should verify supplier certifications, batch-specific documentation, and ensure suppliers are licensed and compliant with regional regulatory standards such as FDA or EMA approvals.

2. Are there biosimilar or generic versions of VOSOL available in the market?
Yes. Patent expiries and licensing agreements have enabled the development of biosimilars and generics, primarily through regional manufacturers and contract manufacturers.

3. What are the risks associated with reliance on a single VOSOL supplier?
Dependence on a sole supplier increases vulnerability to supply disruptions due to manufacturing issues, regulatory delays, or geopolitical factors, underscoring the importance of diversification.

4. How does regional regulation impact VOSOL supply chain management?
Regional regulations influence approvals, manufacturing standards, and distribution logistics, requiring tailored compliance strategies for each market.

5. What are emerging trends affecting VOSOL supply and manufacturing?
Advances in bioprocessing technologies, patent expirations, and global biosimilar development are expanding supplier options, enhancing supply resilience, and reducing costs.

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Sources

1. World Health Organization. "Guidelines on Quality, Safety and Efficacy of Biotherapeutic Medicines." WHO Press, 2021.
2. PharmaGenix Inc. Official Website. "VOSOL Product Information." Accessed March 2023.