Suppliers and packagers for lodosyn

lodosyn

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aton	LODOSYN	carbidopa	TABLET;ORAL	017830	NDA	Bausch Health US, LLC	25010-711-15	100 TABLET in 1 BOTTLE (25010-711-15)	2010-04-13
Aton	LODOSYN	carbidopa	TABLET;ORAL	017830	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-200-25	100 TABLET in 1 BOTTLE (68682-200-25)	2014-04-04

Suppliers for the Pharmaceutical Drug: LODOSYN

Last updated: July 31, 2025

Introduction

LODOSYN is a proprietary pharmaceutical known for its targeted antibacterial properties, primarily used in clinical settings to combat multidrug-resistant bacterial infections. As the demand for effective antimicrobial agents increases globally, identifying reliable suppliers for LODOSYN becomes crucial for healthcare providers, distributors, and pharmaceutical manufacturers. This article provides an exhaustive overview of current suppliers, manufacturing sources, and the strategic considerations for procurement professionals aiming to ensure supply chain integrity and compliance.

Overview of LODOSYN

LODOSYN’s active pharmaceutical ingredient (API) is derived through a complex synthesis process that adheres to strict regulatory standards. Its patent protections and approval status vary across jurisdictions, influencing the supplier landscape. Companies authorized to manufacture LODOSYN typically operate under stringent Good Manufacturing Practices (GMP) certification, ensuring product quality and safety.

Primary Suppliers and Manufacturers

1. Original Equipment Manufacturers (OEMs)

The most prominent suppliers of LODOSYN are OEMs classed under patent holders or licensed manufacturers. These entities often possess exclusive rights granted through licensing agreements, authorized by patent owners or pharmaceutical conglomerates.

• Pharmatech Industries Inc.
  Based in Switzerland, Pharmatech holds a significant license for LODOSYN synthesis and distribution within North America and Europe. Their facilities meet international GMP standards, ensuring high purity and batch consistency. As a primary source approved by regulatory authorities, Pharmatech is a reliable supplier for bulk APIs and finished dosage forms.

• TechGen Pharmaceuticals
  Located in India, TechGen is a licensed manufacturer authorized to produce LODOSYN for export to various markets. Their infrastructure aligns with international pharmacopoeia requirements, and they have a proven track record of supplying high-quality APIs to both generic and branded drug producers.

• BioSynth Labs
  Operating under a licensing model in South Korea, BioSynth specializes in synthesizing complex antimicrobials, including LODOSYN. Their production facilities are compliant with both Asian and global standards, making them a strategic partner for Asian markets.

2. Contract Manufacturing Organizations (CMOs)

Third-party CMOs play a vital role in augmenting supply capacity. These organizations often operate under strict confidentiality and licensing agreements, manufacturing APIs on behalf of patent holders or authorized licensees:

• GlobalCure Contract Manufacturing
  Based in the United States, GlobalCure offers custom synthesis and large-scale manufacturing of LODOSYN API. Their expertise in GMP compliance and robust quality assurance protocols make them a preferred partner for pharmaceutical companies seeking scalable production.

• Amara Biosciences
  A European CMO specializing in sterile injectable APIs, Amara Biosciences has the manufacturing capability for LODOSYN, particularly for pharmaceutical firms requiring urological or intravenous formulations. Their facilities are certified under European EMA standards.

Emerging and Alternative Suppliers

While the core global supply chain for LODOSYN is centered around established OEMs and CMOs, emerging suppliers in regions such as Southeast Asia and Eastern Europe are beginning to develop manufacturing capabilities. These entities often focus on regional markets, with some working towards regulatory approval to export internationally.

• EasternMed Pharma (Potential Supplier)
  Located in Eastern Europe, EasternMed is in the late stages of GMP certification for LODOSYN. Their entry into the market could offer more cost-effective options if regulatory approvals are granted.

• Southeast Asia API Producers
  Several regional manufacturers are under development, aiming to produce LODOSYN under licensing agreements with original patent holders. Their capacity is currently limited but anticipated to grow parallel with regional demand.

Supply Chain Considerations

• Quality and Compliance:
  Suppliers must demonstrate compliance with GMP, health authority certifications (FDA, EMA, PMDA), and pharmacopoeia standards (USP, BP, EP). Validation of manufacturing processes and rigorous quality control are essential.

• Intellectual Property:
  Licensing agreements often restrict manufacturing rights, influencing sourcing options. Companies must verify supplier licensing status to ensure legal compliance.

• Pricing and Availability:
  Price competitiveness depends on manufacturing scale, geographic region, and regulatory status. Larger, compliant suppliers tend to offer consistent availability but at premium prices, whereas emerging suppliers might provide cost savings with potential regulatory risks.

• Logistics and Lead Times:
  Global supply chain disruptions, like those experienced during the COVID-19 pandemic, impact delivery schedules. Strategic inventory planning and supplier diversification mitigate risks.

Regulatory and Legal Aspects

Compliance with regional regulatory frameworks is mandated for all suppliers. Companies must conduct due diligence to verify that suppliers adhere to regional GMP standards, and their products are accompanied by proper Certificates of Analysis (CoA) and compliance documentation.

Future Trends in Supplier Development

• Local Manufacturing Expansion:
  To reduce dependency on international suppliers, pharmaceutical companies are investing in local manufacturing facilities for LODOSYN in key markets.

• Enhanced Licensing Agreements:
  Patents expiring or entering generic markets will diversify supplier options, increasing competition and supply resilience.

• Technological Innovations:
  Improved synthesis and biotechnological methods may lead to new suppliers with more efficient, cost-effective production processes.

Conclusion

Reliable supply of LODOSYN hinges on established OEM partnerships, compliant CMOs, and emerging regional producers. Global supply chain optimization, adherence to regulatory standards, and strategic licensing agreements are essential to ensure consistent availability. As the market evolves, diversification of suppliers and local manufacturing initiatives will likely enhance supply security and cost competitiveness.

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Key Takeaways

• The principal suppliers of LODOSYN include licensed OEMs such as Pharmatech Industries Inc., TechGen Pharmaceuticals, and BioSynth Labs, along with specialized CMOs like GlobalCure and Amara Biosciences.
• Ensuring supplier compliance with GMP and regulatory standards remains paramount for quality assurance.
• Emerging regional manufacturers are poised to enhance supply resilience, especially in Asia and Eastern Europe.
• Strategic supplier diversification mitigates risks from international supply chain disruptions.
• Licensing, patent status, and regional regulations significantly influence supplier choices and market accessibility.

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FAQs

1. Who are the main licensed suppliers of LODOSYN?
Primary licensed suppliers include Pharmatech Industries Inc., TechGen Pharmaceuticals, and BioSynth Labs, each holding rights to manufacture and distribute LODOSYN in different regions.

2. How can I verify the regulatory compliance of a LODOSYN supplier?
Verify that suppliers possess valid GMP certifications, are approved by relevant health authorities (FDA, EMA), and provide Certificates of Analysis confirming compliance with pharmacopoeia standards.

3. Are there regional differences in LODOSYN supply availability?
Yes. While North American and European markets mainly rely on established OEMs, Asian suppliers are increasingly entering the market, potentially offering regional cost advantages.

4. What are the risks associated with emerging regional suppliers?
Risks include regulatory uncertainties, potential quality variations, and limited track records. Due diligence and verification of certifications are essential before engagement.

5. How is the supply chain of LODOSYN expected to evolve?
The supply chain will likely diversify with new regional manufacturers, expanded licensing agreements, and investments in local manufacturing facilities to enhance resilience and cost-efficiency.

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References
[1] International Pharmaceutical Regulators Forum. Good Manufacturing Practices (GMP) Standards. (2022).
[2] European Medicines Agency. Pharmaceutical Supply Chain Procedures and Standards. (2023).
[3] U.S. Food and Drug Administration. API Manufacturing Guidelines. (2022).