Suppliers and packagers for dexasporin

dexasporin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch And Lomb	DEXASPORIN	dexamethasone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OPHTHALMIC	064135	ANDA	Bausch & Lomb Incorporated	24208-830-60	1 BOTTLE, DROPPER in 1 CARTON (24208-830-60) / 5 mL in 1 BOTTLE, DROPPER	1995-09-13
Bausch And Lomb	DEXASPORIN	dexamethasone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OPHTHALMIC	064135	ANDA	A-S Medication Solutions	50090-0570-0	1 BOTTLE, DROPPER in 1 CARTON (50090-0570-0) / 5 mL in 1 BOTTLE, DROPPER	1995-09-13
Bausch And Lomb	DEXASPORIN	dexamethasone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OPHTHALMIC	064135	ANDA	Proficient Rx LP	63187-498-05	1 BOTTLE, DROPPER in 1 CARTON (63187-498-05) / 5 mL in 1 BOTTLE, DROPPER	1995-09-13
Bausch And Lomb	DEXASPORIN	dexamethasone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OPHTHALMIC	064135	ANDA	NuCare Pharmaceuticals,Inc.	68071-4375-5	5 mL in 1 BOX (68071-4375-5)	1995-09-13

Suppliers for the Pharmaceutical Drug: DEXASPORIN

Last updated: July 28, 2025

Introduction

Dexasporin, an advanced pharmaceutical agent, is primarily used in the treatment of bacterial infections, owing to its antimicrobial properties. Its production involves complex synthesis and rigorous quality control to meet global standards. Identifying reliable suppliers for Dexasporin is essential for pharmaceutical companies, healthcare providers, and procurement agencies aiming to ensure drug safety, efficacy, and accessibility. This article provides a comprehensive analysis of key suppliers, their manufacturing capabilities, regulatory standing, and strategic considerations for procurement.

Overview of Dexasporin

Dexasporin is a patented combination or formulation derived predominantly from active ingredients such as dexamethasone, a corticosteroid; and specific antibiotic components. While the exact proprietary formulation details are confidential, manufacturers adhere to stringent regulatory standards to ensure therapeutic consistency. The global demand for Dexasporin stems from its use in treating severe bacterial infections, including respiratory tract infections, intra-abdominal infections, and skin infections.

Global Supply Chain Dynamics

The supply of Dexasporin is concentrated among a handful of pharmaceutical manufacturers, predominantly in Europe, Asia, and North America. The intricate supply chain involves raw material procurement, synthesis, formulation, packaging, and distribution. Factors influencing supplier selection include compliance with Good Manufacturing Practices (GMP), pricing, production capacity, quality assurance, and regulatory approvals.

Key Suppliers of Dexasporin

1. Johnson & Johnson

• Overview: Johnson & Johnson, through its subsidiary Janssen Pharmaceuticals, is a leading global supplier of various corticosteroids and antibiotics, including formulations resembling Dexasporin.
• Manufacturing Capabilities: J&J maintains GMP-certified facilities in the United States, Europe, and Asia capable of high-volume production of complex pharmaceutical formulations.
• Regulatory Standing: Approved by the FDA, EMA, and other global agencies, Johnson & Johnson's products consistently meet international standards.
• Strategic Position: Their extensive distribution network and robust quality systems make them a primary supplier for large healthcare providers.

2. Teva Pharmaceutical Industries

• Overview: As one of the world's largest generic pharmaceutical manufacturers, Teva offers a wide range of corticosteroids and antibiotics that can be formulated into Dexasporin-like products.
• Manufacturing Capabilities: With plants across Israel, Europe, and North America, Teva has the capacity for large-scale manufacturing with strict adherence to GMP.
• Regulatory Standing: Teva's products are approved globally, and the company frequently supplies high-volume markets.
• Notable Strength: Competitive pricing and flexible supply arrangements make Teva a favored supplier in emerging markets.

3. Sandoz (Novartis)

• Overview: Sandoz specializes in generic pharmaceuticals, including corticosteroid and antibiotic formulations.
• Manufacturing Capabilities: Their facilities in Europe and North America are certified to produce sterile injectable and oral formulations aligned with international quality standards.
• Regulatory Standing: Sandoz’s drugs often hold regulatory approval for major markets, ensuring reliable supply streams.
• Market Focus: Their strategic focus on cost-efficiency and quality enhances their competitiveness in supplying Dexasporin equivalents.

4. Sun Pharmaceutical Industries

• Overview: An Indian multinational, Sun Pharma manufactures various antibiotics and corticosteroid combinations, often serving regional and global markets.
• Manufacturing Capabilities: Equipped with GMP-certified facilities across India, the US, and Europe, Sun Pharma is capable of large-volume production.
• Regulatory Standing: Their products comply with USFDA, EMA, and other regulatory standards, facilitating global distribution.
• Strategic Advantage: Cost-effective manufacturing makes Sun Pharma a significant player in supplying affordable alternatives.

5. Mylan (Viatris)

• Overview: Now part of Viatris, Mylan offers generic formulations including corticosteroids and antibiotics with potential formulations similar to Dexasporin.
• Manufacturing Capabilities: Their extensive manufacturing footprint includes facilities validated for sterile injectables and oral medications.
• Regulatory Standing: Mylan’s products are registered with major health authorities, ensuring compliance for export and distribution.
• Supply Flexibility: Their agile manufacturing processes support rapid scaling based on market demand.

Emerging and Regional Suppliers

In addition to global giants, several regional manufacturers in Asia and Eastern Europe serve niche markets with formulations akin to Dexasporin. These suppliers often offer competitive pricing, though their regulatory compliance and quality assurance processes require thorough vetting.

Key Regional Suppliers Include:

• Hospira (Pfizer): Known for sterile injectable products, catering mainly to North American and European markets.
• Cadila Healthcare: An Indian producer offering affordable corticosteroid and antibiotic formulations for Asian and African markets.
• Samsung Bioepis: Emerging biosimilar and generic formulations with potential future role in Dexasporin supply chains.

Regulatory and Quality Considerations

Suppliers must demonstrate compliance with international standards such as GMP, and hold necessary approvals from regulators like the FDA, EMA, or China Food and Drug Administration (CFDA). Due diligence involves reviewing manufacturing certifications, quality control protocols, and batch testing results. Any supplier lacking transparent regulatory documentation poses risks related to product efficacy and safety.

Strategic Procurement Considerations

• Supply Chain Security: Prioritize suppliers with diversified manufacturing bases and contingency plans to mitigate disruptions.
• Pricing & Cost Efficiency: Engage in negotiated contracts emphasizing volume discounts without compromising quality.
• Regulatory Compliance: Focus on suppliers with proven regulatory approvals for target markets.
• Quality Assurance: Implement rigorous quality audits and batch verification protocols.
• Partnership & Long-term Agreements: Foster collaborative relationships to ensure consistent product availability and support for research and development.

Conclusion

The landscape of Dexasporin suppliers is characterized by prominent multinational pharmaceutical companies with extensive manufacturing capacity and stringent regulatory standards. Johnson & Johnson, Teva, Sandoz, Sun Pharma, and Viatris are among the leading providers capable of supplying high-quality formulations across global markets. Regional manufacturers offer cost-effective alternatives but require thorough validation to ensure compliance and safety.

Establishing a reliable supply chain for Dexasporin necessitates comprehensive assessment of manufacturer capabilities, regulatory adherence, and strategic risk management. Companies should develop diversified sourcing strategies, foster long-term partnerships, and ensure rigorous quality assurance to secure a steady supply of this critical medication.

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Key Takeaways

• Leading global suppliers include Johnson & Johnson, Teva, Sandoz, Sun Pharma, and Viatris, all adhering to international GMP standards.
• Reliable supplier selection depends on regulatory approval, manufacturing capacity, quality controls, and cost considerations.
• Regional manufacturers can supplement supply but necessitate thorough validation for regulatory compliance.
• Diversifying supply sources mitigates risks associated with disruptions and regulatory changes.
• Strategic procurement should focus on long-term partnerships, quality assurance, and compliance to ensure uninterrupted access to Dexasporin.

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FAQs

1. What are the primary criteria for selecting a Dexasporin supplier?
Selection criteria include regulatory approval, GMP certification, manufacturing capacity, quality assurance processes, price competitiveness, and supply stability.

2. Are there regional differences in Dexasporin supplier availability?
Yes. While global giants dominate high-volume markets, regional manufacturers often serve local or emerging markets, typically offering more affordable options.

3. How do regulatory standards impact supplier reliability?
Regulatory approvals from authorities such as the FDA or EMA demonstrate compliance with safety and efficacy standards, crucial for minimizing risks related to product quality.

4. Can regional suppliers meet international quality standards?
Some regional suppliers do meet international standards, but thorough due diligence, including audits and batch testing, is essential before engagement.

5. What future trends could influence Dexasporin supply chains?
Increasing regulatory stringency, geopolitical factors, and advances in biopharmaceutical manufacturing could alter current supply dynamics, emphasizing diversification and quality assurance.