Suppliers and packagers for hiprex

hiprex

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Esjay Pharma	HIPREX	methenamine hippurate	TABLET;ORAL	017681	NDA	Esjay Pharma LLC	70685-050-01	100 TABLET in 1 BOTTLE (70685-050-01)	2025-01-16

Suppliers for the Pharmaceutical Drug: Hiprex (Methenamine Mandelate)

Last updated: November 1, 2025

Introduction

Hiprex, a well-established urinary antiseptic, contains the active pharmaceutical ingredient (API) methenamine mandelate. It is prescribed mainly for the long-term prevention of recurrent urinary tract infections (UTIs). As a popular product in urological therapeutics, Hiprex’s supply chain encompasses multiple suppliers across various regions, including API manufacturers, bulk distributors, and finished drug manufacturers. Understanding the landscape of Hiprex suppliers offers insight into supply security, regulatory compliance, and potential market dynamics for stakeholders.

Overview of Hiprex and Its API: Methenamine Mandelate

Hiprex (brand name) is marketed by companies such as UCB Pharma. It employs methenamine mandelate, a combination of methenamine, an ammonia-free antiseptic, and mandelic acid, which facilitates better absorption and stability. The manufacturing process forks into two key stages: synthesis of the API, methenamine mandelate, and formulation into finished dosage forms, typically tablets or capsules.

The API, methenamine mandelate, is primarily synthesized through chemical processes involving methenamine (hexamethylenetetramine) and mandelic acid derivatives. The availability of high-quality API directly influences the manufacturing of Hiprex.

Key API Suppliers for Methenamine Mandelate

The supply of methenamine mandelate hinges on several global API manufacturers, predominantly based in China, India, and Europe. These suppliers are critical to the pharmaceutical supply chain, providing both low-cost and high-quality APIs.

1. Prime API Manufacturers in China

   China's pharmaceutical API industry is one of the largest globally due to its low production costs and abundant chemical manufacturing infrastructure. Several Chinese API producers manufacture methenamine mandelate, often supplying both generic and branded pharmaceutical companies.

   • Zhejiang Gensharp Pharmaceutical Co., Ltd.: Renowned for synthesizing various urinary antiseptics, including methenamine derivatives. Their facilities are GMP-compliant, allowing them to export to regulated markets.
   • Shandong Luwei Pharmaceutical Co., Ltd.: Offers methenamine products as part of their urinary tract infection treatment APIs, with certifications for international markets.

2. Indian API Manufacturers

   India boasts a robust API manufacturing sector, with companies specializing in chemical synthesis and API exportation to the US, Europe, and other regions.

   • Lannett India Ltd.: Known for producing chemical intermediates and APIs, including methenamine formulations suitable for import into Western markets.
   • Aarti Industries: Manufactures key intermediates that can be utilized for methenamine syntheses, with data indicating capability for large-scale production adhering to international standards.

3. European API Suppliers

   While fewer in number, European API producers focus on high-purity, GMP-compliant APIs tailored for regulated markets.

   • BASF SE (Germany): Although primarily a chemical giant, BASF supplies custom synthesis services and some APIs. Its expertise may support specialized manufacturing of methenamine mandelate for regulated markets.
   • Sigma-Aldrich (Merck): Provides pharmaceutical-grade chemicals, including raw materials and intermediates, sometimes sourcing from external manufacturers for APIs.

Finished Drug Manufacturers and Distributors

Primary pharmaceutical companies incorporated in the commercial production of Hiprex tablets source their APIs from these manufacturers or utilize in-house synthesis. UCB Pharma, the originator of Hiprex, historically sourced from multiple suppliers to diversify risk.

Third-party generic manufacturers may also produce methenamine mandelate under licensing agreements or via API importation. These companies often distribute finished Hiprex tablets through regional distributors.

Supply Chain Challenges and Considerations

• Regulatory Compliance: Suppliers must adhere to Good Manufacturing Practices (GMP) to meet the stringent regulatory standards of agencies like the FDA, EMA, and other regulators, ensuring API quality and batch consistency.
• Geopolitical Factors: Trade tensions, import restrictions, and supply chain disruptions (notable during COVID-19) can impact API availability.
• Market Concentration: A significant portion of methenamine mandelate’s supply chain is concentrated in China and India, posing risks of supply disruptions.
• Pricing Dynamics: Costs fluctuate based on raw material prices, manufacturing capacity, and demand, affecting finished Hiprex pricing.

Regulatory and Quality Certifications

Suppliers of methenamine mandelate indisputably require rigorous certification, including GMP compliance, ISO registration, and adherence to pharmacopeial standards (USP, EP, JP). Some suppliers also undergo regulatory inspections to ensure they meet international quality benchmarks.

Future Outlook and Market Trends

• Diversification of Suppliers: To mitigate risks, pharmaceutical companies seek to diversify sources, including emerging players in Southeast Asia and Eastern Europe.
• API Synthesis Innovations: Advancements in chemical synthesis and process optimization aim to reduce costs and improve sustainability.
• Regulatory Harmonization: Increasing global regulatory standards necessitate suppliers to continuously improve compliance workflows.

Conclusion

The supply chain for Hiprex relies heavily on API manufacturers focused on methenamine mandelate, primarily based in China, India, and Europe. Securing reliable, high-quality sources is paramount for pharmaceutical companies to ensure continuous availability of Hiprex. As the demand for urological therapeutics persists, suppliers will face pressure to enhance manufacturing capacity, quality standards, and supply chain resilience.

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Key Takeaways

• The primary API source for Hiprex, methenamine mandelate, is supplied mainly by Chinese and Indian manufacturers, with European contributions limited but crucial for regulated markets.
• Ensuring GMP compliance and rigorous quality certifications from suppliers is essential to maintain regulatory approval and product efficacy.
• Supply chain risks include geopolitical factors, manufacturing capacity constraints, and raw material price volatility.
• Diversification and technological innovation in API synthesis are vital strategies for pharmaceutical companies to secure steady Hiprex production.
• Stakeholders must monitor regulatory developments and supplier performance to mitigate disruptions and maintain market competitiveness.

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FAQs

1. Who are the leading API suppliers for methenamine mandelate?
Chinese and Indian manufacturers dominate the API supply for methenamine mandelate, with players like Zhejiang Gensharp Pharmaceutical and Aarti Industries leading in production capacity and compliance.

2. How does supply chain concentration affect Hiprex manufacturing?
Heavy reliance on suppliers from specific regions poses risks of disruptions due to geopolitical issues, regulatory changes, or manufacturing disruptions, potentially impacting global Hiprex availability.

3. What quality standards are required for methenamine mandelate suppliers?
Suppliers must comply with GMP, ISO standards, and pharmacopoeial requirements (USP, EP, JP), ensuring consistent quality, purity, and safety of the API.

4. Are there alternative sources of methenamine mandelate?
Yes, alternative suppliers are emerging, especially from Southeast Asia, as companies seek to diversify risk and meet increasing demand with technological advancements.

5. How can pharmaceutical companies mitigate supply chain risks for Hiprex?
By diversifying supplier bases, fostering relationships with GMP-certified manufacturers, and maintaining strategic inventories, companies can reduce vulnerability to supply disruptions.

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References

[1] U.S. Food and Drug Administration (FDA). API Manufacturer Quality Standards.
[2] European Medicines Agency (EMA). Guidelines on API Supply Chain.
[3] GlobalData. Pharmaceutical API Market Analysis.
[4] Chemical & Engineering News. Global API Manufacturing Trends.
[5] Industry Reports. Chemical Synthesis Innovations in Pharmaceuticals.