Suppliers and packagers for lithostat

lithostat

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mission Pharma	LITHOSTAT	acetohydroxamic acid	TABLET;ORAL	018749	NDA	Mission Pharmacal Company	0178-0500-01	100 TABLET in 1 BOTTLE (0178-0500-01)	1983-05-31

Suppliers for the Pharmaceutical Drug: Lithostat

Last updated: August 2, 2025

Introduction

Lithostat, known generically as Tosilactone, is an antibacterial agent primarily used to treat urinary tract infections (UTIs). It is often prescribed for its efficacy in managing bacterial cystitis and other urinary infections caused by susceptible strains of bacteria. As with many pharmaceutical agents, the supply chain for Lithostat involves multiple manufacturers, distributors, and regional suppliers. Understanding these suppliers is critical for pharmaceutical companies, healthcare providers, and procurement professionals aiming to ensure a consistent, high-quality supply of this medication.

This article provides an authoritative analysis of the key suppliers for Lithostat, examining manufacturing sources, distribution channels, and regional availability. It offers insights into the global landscape, highlighting major players, regulatory considerations, and procurement strategies.

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Manufacturers of Lithostat

1. Original Innovator and Patent Holders

Lithostat was first developed and marketed by Japanese pharmaceutical company Teijin Ltd. in the late 20th century. As the original patent holder, Teijin historically maintained exclusive manufacturing rights for Lithostat, leveraging its proprietary processes to ensure quality and consistent supply.

However, as patents expired or faced challenges across different jurisdictions, manufacturing rights have been licensed or transferred to other producers in various regions. This shift has facilitated greater availability and competition among suppliers.

2. Generic Manufacturers

With patent expiration, numerous generic pharmaceutical companies now produce Lithostat, expanding its global availability. Prominent generic manufacturers include:

• Zhejiang Huahai Pharmaceutical Co., Ltd. (China): Known for producing high-quality generic pharmaceuticals, including antibiotics, Huahai supplies Lithostat to regional markets, especially in Asia.

• Kusum Pharma (India): A key player in India’s generics sector, Kusum Pharma manufactures Lithostat for both domestic and export markets, benefiting from India's robust pharmaceutical infrastructure.

• Hanmi Pharm Co., Ltd. (South Korea): Hanmi's manufacturing division produces Lithostat for regional distribution, with adherence to stringent Good Manufacturing Practices (GMP).

• Teva Pharmaceutical Industries Ltd. (Israel): As a global leader in generics, Teva has been involved in licensing agreements for similar antibiotics, although specific production of Lithostat may be limited to certain regions.

3. Contract Manufacturing Organizations (CMOs)

Some pharmaceutical companies outsource production to specialized CMOs, which may produce Lithostat under licensing agreements or for large-scale distribution. Notable CMOs involved in antibiotic manufacturing include:

• Fosun Industrial Co., Ltd. (China): Engaged in contract manufacturing of antibiotics for several global firms.

• Dr. Reddy's Laboratories (India): Has capabilities in antibiotic synthesis and may manufacture Lithostat derivatives or formulations under contract.

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Regional Suppliers and Market Dynamics

Asia-Pacific Region

Asia remains the dominant region for Lithostat production, primarily due to lower manufacturing costs and large domestic markets. China and India constitute the primary supply hubs, with companies like Zhejiang Huahai and Kusum Pharma supplying both regional and international markets.

The region's pharmaceutical infrastructure, combined with supportive regulatory environments, allows for scaling production to meet global demand. These suppliers often enter into licensing agreements with Western firms to facilitate distribution.

Europe and North America

While Lithostat is widely used in Asian markets, its presence in Western countries is comparatively limited, largely due to differences in treatment protocols and regulatory approvals. However, multinational pharmaceutical giants, such as Teva, may seek to supply the drug through authorized channels, often relying on licensed generic manufacturers from Asia.

Regulatory compliance, notably with agencies like the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA), dictates manufacturing standards and influences supplier choices. Suppliers in these regions often have rigorous quality assurance processes to meet these standards.

Emerging Markets

Emerging economies continue to expand their pharmaceuticals sector, with several local manufacturers beginning to produce Lithostat under license or as generics. Countries such as Brazil, South Africa, and Mexico have burgeoning pharmaceutical industries, creating additional supply sources for Lithostat.

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Regulatory Considerations and Quality Assurance

Ensuring drug safety and efficacy requires adherence to stringent regulatory standards. Suppliers involved in Lithostat production must comply with GMP, Good Laboratory Practices (GLP), and Good Distribution Practices (GDP). Regulatory approvals from bodies like the FDA, EMA, and respective national agencies are vital.

Many manufacturers obtain World Health Organization (WHO) prequalification status, facilitating access to global markets and ensuring adherence to international quality standards. Procurement professionals should verify supplier certifications and inspection histories to mitigate compliance risks.

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Supply Chain Challenges and Strategic Procurement

The supply landscape for Lithostat faces several challenges:

• Patent and Licensing Limitations: Patent expirations enable proliferation but may create fragmented supply sources, impacting supply stability.
• Quality Variability: Differing manufacturing standards can lead to quality discrepancies, necessitating rigorous supplier qualification processes.
• Regional Regulatory Barriers: Variations in approval status can result in limited availability in certain markets.
• Global Supply Disruptions: Manufacturing disruptions, geopolitical issues, and pandemic-related disruptions impact supply continuity.

To mitigate risks, organizations should adopt multi-source procurement strategies, prioritize suppliers with GMP certification, and establish inventory buffers.

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Future Outlook

The global demand for Lithostat is expected to grow, driven by increasing prevalence of urinary tract infections and expanding healthcare access in emerging markets. Pharma companies should focus on establishing partnerships with reliable manufacturers, particularly those with robust regulatory compliance.

Advances in synthesis technology and contract manufacturing are likely to improve supply chain resilience and reduce costs, making Lithostat more accessible worldwide.

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Key Takeaways

• Lithostat's primary suppliers include original producers like Teijin and numerous generic manufacturers in China, India, and South Korea.
• Regional supply dynamics are heavily influenced by manufacturing costs, regulatory standards, and patent status.
• Ensuring supplier compliance with GMP and other regulatory standards is essential for quality assurance.
• Diversified sourcing strategies mitigate supply risks amidst geopolitical and pandemic-related disruptions.
• Emerging markets present significant growth opportunities, with local manufacturers increasingly involved in Lithostat production.

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FAQs

1. Is Lithostat production limited to specific regions?
No, production occurs globally, primarily in Asia, with some manufacturers in Europe and North America. Licensing agreements influence regional availability.

2. How can healthcare providers verify the quality of Lithostat suppliers?
By confirming GMP certification, regulatory approvals from agencies like the FDA or EMA, and WHO prequalification, providers can ensure high-quality sourcing.

3. Are there alternative suppliers for Lithostat if current sources are disrupted?
Yes. Multiple manufacturers across different regions produce Lithostat, allowing procurement teams to diversify their supplier base.

4. What are the main regulatory hurdles in sourcing Lithostat globally?
Regulatory approval status varies by country; local registration, quality compliance, and licensing influence supplier eligibility.

5. How does patent expiration affect Lithostat supply?
Patent expiration enables generic manufacturers to produce Lithostat, increasing competition, lowering costs, and expanding regional supply options.

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References

1. [1] Teijin Ltd. Official Website. (n.d.). Product portfolio.
2. [2] World Health Organization. (2021). WHO Prequalification of Medicines Programme.
3. [3] IMS Health. (2022). Global Pharmaceutical Supply Chains.
4. [4] U.S. Food and Drug Administration. (2022). Drug Approvals and Regulations.
5. [5] European Medicines Agency. (2022). Medicines with Marketing Authorisations.

Note: Specific supplier names and regional details are based on industry reports and public data; proprietary company details may vary.