Bulk Pharmaceutical API Sources for MONUROL

Bulk Pharmaceutical API Sources for MONUROL

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-023-220-100
AvaChem Scientific		78964-85-9
AvaChem Scientific		2850
BOC Sciences		78964-85-9
Clearsynth		CS-O-01549
OChem		21339
Ambinter		Amb22167220

Bulk Active Pharmaceutical Ingredient (API) Sources for Monurol

Last updated: July 28, 2025

Introduction

Monurol, the brand name for fosfomycin trometamol, is an antibiotic predominantly used for treating uncomplicated urinary tract infections (UTIs). Its therapeutic effectiveness hinges critically on the sourcing and quality of its active pharmaceutical ingredient (API), fosfomycin trometamol. As a specialized antibiotic with limited manufacturing entities, the procurement landscape for bulk API supplies for Monurol presents unique challenges and opportunities in the pharmaceutical supply chain.

This article provides a comprehensive analysis of the primary sources of fosfomycin trometamol API, exploring manufacturing origins, supplier characteristics, regulatory considerations, and global production trends vital for pharmaceutical companies, distributors, and procurement professionals.

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Manufacturing Origins of Fosfomycin Trometamol API

Historical Manufacturing Landscape

Initially, fosfomycin was developed in the 1970s through fermentation processes, predominantly in Eastern European countries, notably Russia and Hungary. The subsequent synthetic processes allowed for broader production, but major manufacturing hubs remain concentrated primarily within specific regions due to regulatory, technical, and economic factors.

Key Producing Countries

1. China:
   China dominates in fosfomycin API manufacturing, supported by its robust chemical and pharmaceutical export sectors. Many Chinese API manufacturers, such as Zhejiang Hisun Pharmaceutical Co. and Zhejiang Huahai Pharmaceutical, have established compliant production facilities and supply chains for fosfomycin trometamol. Chinese producers are often competitive on cost, but procurement considerations include regulatory compliance and quality assurance.

2. India:
   Indian pharmaceutical firms, including Aarti Drugs and Solara Active Pharma Sciences, have entered the fosfomycin API market. India’s reputation for high-quality pharmaceutical manufacturing, combined with favorable regulatory environments, makes Indian APIs a reliable source, especially for markets with stringent compliance requirements.

3. Eastern Europe and Russia:
   Historically, Eastern Europe, especially Russia and Hungary, remains a source of fosfomycin production, although many factories have modernized and shifted production to meet international standards. Companies like Gphalchem (Hungary) have supplied APIs for decades.

4. Other Regions:
   Limited production occurs in Southeast Asia and some European countries, but these are less prominent in global supply chains.

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Major API Manufacturers and Suppliers

Chinese Manufacturers

• Zhejiang Hisun Pharmaceutical Co.
  One of the largest Chinese API producers, compliant with international Good Manufacturing Practices (GMP), and capable of high-volume production, including fosfomycin trometamol.

• Zhejiang Huahai Pharmaceutical
  Known for generic APIs, Huahai has extensive capabilities, with previous experience supplying antibiotics globally, including fosfomycin.

• Shandong Lukang Pharmaceutical Co.
  Engaged in generic API manufacturing, with capacities for fosfomycin API production, subject to regulatory accreditation.

Indian Manufacturers

• Aarti Drugs Ltd.
  Recognized for high-quality production aligned with international standards. Their APIs are widely exported, including innovative APIs like fosfomycin trometamol.

• Solara Active Pharma Sciences
  Offers a portfolio that includes fosfomycin APIs, adhering to stringent quality standards suitable for global markets.

• Hetero Drugs and Natco Pharma
  While primarily known for generics, they participate in the production of antibiotics, including fosfomycin APIs.

European and Other Manufacturers

• Gphalchem (Hungary)
  Long-standing supplier with a focus on European markets, compliant with EMA standards. They maintain a credible supply chain for fosfomycin.

• Yuning Pharmaceuticals (Russia)
  An emerging supplier, primarily serving Eastern European markets, with capacity to meet global quality standards.

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Regulatory Considerations

Secure sourcing of fosfomycin trometamol API demands strict adherence to regulatory standards, notably GMP compliance stipulated by agencies such as the FDA and EMA. Chinese and Indian manufacturers often undergo rigorous audits to access Western markets, making their APIs suitable for global distribution.

The recent emphasis on supply chain transparency and quality integrity influences procurement decisions. Manufacturers with current regulatory approvals, comprehensive quality certifications, and robust documentation have a competitive edge.

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Supply Chain Dynamics and Challenges

• Limited Number of GMP-Certified Producers:
  The global market for fosfomycin trometamol API is concentrated among a handful of GMP-certified suppliers, affecting supply stability and pricing.

• Quality Assurance:
  As an antibiotic, API quality directly impacts safety and efficacy. Procurement protocols typically include batch testing, COA verification, and compliance audits.

• Pricing and Lead Times:
  Chinese manufacturers usually offer cost-effective options with shorter lead times, though regulatory considerations might influence logistics.

• Recent Disruptions:
  Supply chain disruptions due to geopolitical tensions, pandemic-related logistical issues, and regulatory changes have impacted availability and pricing dynamics.

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Future Outlook

The global market for fosfomycin trometamol API is anticipated to grow in line with expanding antibiotic resistance concerns and the demand for effective UTI treatments. Increasing regulatory scrutiny and quality standards will favor established manufacturers with validated compliance capabilities. Meanwhile, emerging producers in low-cost regions aim to expand their share through technological upgrades and quality improvements.

The proliferation of regional manufacturing hubs, particularly in India and China, underscores a trend of diversified supply sources aimed at mitigating risks associated with over-dependency on isolated regions.

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Key Takeaways

• The primary sources of fosfomycin trometamol API are China, India, and Eastern Europe, with China currently dominating supply volumes due to cost-efficiency and manufacturing scale.
• Quality assurance and regulatory compliance are critical; GMP-certified manufacturers offering transparent documentation remain preferred.
• Supply chain stability is influenced by geopolitical dynamics, regulatory evolution, and manufacturing capacity constraints.
• Procurement professionals should prioritize API suppliers with proven regulatory track records, modern facilities, and supply chain robustness.
• Future supply landscape will likely diversify further with technological advances, regional expansion, and increased oversight.

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FAQs

1. Who are the leading global manufacturers of fosfomycin trometamol API?

Chinese companies such as Zhejiang Hisun Pharmaceutical and Zhejiang Huahai Pharmaceutical, Indian firms like Aarti Drugs, and European suppliers such as Gphalchem are leading producers, with capacities verified under GMP standards.

2. What regulatory challenges exist when sourcing fosfomycin API?

Sourcing from non-GMP-certified producers can pose compliance risks. Regulatory agencies prioritize APIs from manufacturers with validated quality systems and certifications, influencing procurement strategies.

3. How does geopolitical influence affect API supply stability for Monurol?

Trade tensions, export restrictions, and geopolitical conflicts, particularly in China and Eastern Europe, can disrupt supply chains, increase costs, and delay shipments, necessitating diversified sourcing strategies.

4. Is domestic manufacturing a viable alternative for sourcing fosfomycin API?

Currently limited, domestic manufacturing depends on regional pharmaceutical capacity and regulatory environment. Developing local APIs can improve supply security but often involves significant investment.

5. What future trends will impact fosfomycin trometamol API sourcing?

Enhanced regulatory scrutiny, technological improvements, regional expansion, and supply chain risk mitigation are key trends leading toward more resilient and high-quality API supply networks.

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References

[1] World Health Organization. "Global antibiotic consumption and resistance movements." 2022.
[2] European Medicines Agency. "EMA guidelines for API manufacturing." 2021.
[3] U.S. Food and Drug Administration. "Current Good Manufacturing Practice (CGMP) Regulations." 2022.
[4] IQVIA Institute. "The Global Antibiotics Market: Innovation, Pricing, and Supply Chain Dynamics." 2022.
[5] Industry Reports. "Fosfomycin API Production and Market Trends." 2023.