Suppliers and packagers for generic pharmaceutical drug: METHENAMINE HIPPURATE

METHENAMINE HIPPURATE

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
Aurobindo Pharma Ltd	METHENAMINE HIPPURATE	methenamine hippurate	TABLET;ORAL	205661	ANDA	Aurobindo Pharma Limited	65862-782-01	100 TABLET in 1 BOTTLE (65862-782-01)	2016-07-05
Aurobindo Pharma Ltd	METHENAMINE HIPPURATE	methenamine hippurate	TABLET;ORAL	205661	ANDA	NorthStar Rx LLC	72603-816-01	100 TABLET in 1 BOTTLE (72603-816-01)	2025-04-01
Jubilant Cadista	METHENAMINE HIPPURATE	methenamine hippurate	TABLET;ORAL	217675	ANDA	Jubilant Cadista Pharmaceuticals Inc.	59746-797-01	100 TABLET in 1 BOTTLE (59746-797-01)	2023-01-24
Jubilant Cadista	METHENAMINE HIPPURATE	methenamine hippurate	TABLET;ORAL	217675	ANDA	Jubilant Cadista Pharmaceuticals Inc.	59746-797-65	20 TABLET in 1 BOTTLE (59746-797-65)	2023-01-24

Suppliers for the Pharmaceutical Drug: Methenamine Hippurate

Last updated: July 29, 2025

Introduction

Methenamine hippurate, a well-established urinary antiseptic, remains a critical therapeutic agent for managing chronic urinary tract infections (UTIs). Its efficacy is rooted in its mechanism of releasing formaldehyde within the urinary tract, thereby exerting bactericidal effects. As demand persists globally, an intricate network of suppliers has emerged, ranging from raw material producers to finished drug manufacturers. This article provides a comprehensive overview of key suppliers, emphasizing sourcing dynamics, geographic distribution, regulatory considerations, and market trends critical for stakeholders involved in procurement and strategic planning.

Understanding Methenamine Hippurate

Methenamine hippurate comprises methenamine (hexamethylenetetramine) and hippuric acid. The former is a heterocyclic compound capable of generating formaldehyde under acidic conditions, whereas the latter acts as a carrier facilitating absorption and distribution. Manufacturing involves synthesizing methenamine from formaldehyde and ammonia, subsequently combining it with hippuric acid to form the compound. Consequently, suppliers span across chemical intermediates' producers, pharmaceutical excipients, and finished formulation developers.

Global Raw Material Suppliers

1. Formaldehyde and Ammonia Sources

The production of methenamine hinges on high-purity formaldehyde and ammonia. Major chemical conglomerates responsible for these raw materials include:

• BASF (Germany): One of the world's largest producers of formaldehyde and ammonia, BASF supplies pharmaceutical-grade chemicals globally, adhering to stringent quality standards (ISO 9001, GMP). Their extensive manufacturing footprint ensures reliable supply chains.[1]

• Celanese Corporation (USA): A leading producer of formaldehyde, Celanese offers custom solutions tailored for pharmaceutical applications, emphasizing purity and consistent batch quality.[2]

• Lubrizol Advanced Materials (USA): Specializes in specialty chemicals with capabilities in producing formaldehyde derivatives suitable for medicinal purposes.[3]

• Yara International (Norway): Prominent in ammonia production, Yara supplies pharmaceutical-grade ammonia with high purity, critical for methenamine synthesis.[4]

2. Hippuric Acid and Related Components

Although hippuric acid can be sourced directly from natural origins, most pharmaceutical-grade hippuric acid is synthesized in-house or purchased from chemical intermediates suppliers:

• Deeply Integrated Chemical Companies: Many chemical conglomerates, such as Eastman Chemical Company and Sigma-Aldrich (part of Merck), supply chemically synthesized hippuric acid and intermediates.[5]

• Specialty Chemical Distributors: Distributors like Thermo Fisher Scientific and Alfa Aesar provide laboratory-grade hippuric acid and related compounds, suitable for formulation development and small-scale manufacturing.[6]

Active Pharmaceutical Ingredient (API) Manufacturers

1. Global API Producers

The synthesis of methenamine hippurate as a finished pharmaceutical product involves complex chemical procedures, typically undertaken by specialized API manufacturers:

• Hikma Pharmaceuticals (UK): Known for producing high-quality APIs and formulations, Hikma sources methenamine from regional chemical suppliers, incorporating it into finished products for markets in Europe and the Middle East.[7]

• Rottapharm (Italy): This company manufactures methenamine-based products and offers customized formulations, serving domestic and export markets.[8]

• Cambridge Isotope Laboratories (USA): Provides isotope-labeled precursors for research and development of new formulations or analytical standards.[9]

• LGM Pharma (USA): Acts as a distributor and bulk supplier of pharmaceutical intermediates including methenamine, catering to pharmaceutical manufacturers globally.[10]

2. Regional Suppliers and Emerging Markets

Emerging manufacturers in India, China, and Eastern Europe are expanding the supply landscape:

• Shenzhen Aoke Biotechnology (China): Supplies methenamine bulk powder at competitive prices, primarily serving Asian markets.[11]

• VACSERA (Egypt): An established regional manufacturer providing methenamine API, supporting North African and Middle Eastern formulations.[12]

• Kusum Pharma (India): An emerging pharmaceutical firm producing methenamine formulations, with capabilities to meet domestic demand.[13]

Finished Formulations and Contract Manufacturing

Many pharmaceutical companies do not produce methenamine hippurate in-house but rely on Contract Manufacturing Organizations (CMOs):

• Bendiner & Co. (USA): Offers custom synthesis and formulation services, including methenamine hippurate tablets and capsules.[14]

• Sinthesis Pharma (India): Provides ready-to-market methenamine hippurate formulations adhering to WHO and domestic GMP standards.[15]

Regulatory and Quality Standards

Suppliers must comply with international and regional pharmaceutical regulations, including:

• Good Manufacturing Practices (GMP)
• United States Pharmacopeia (USP) standards
• European Pharmacopoeia (EP) standards
• ISO certifications

Quality assurance is paramount since methenamine hippurate acts within sensitive urinary systems, and impurities can compromise safety and efficacy.

Market Trends and Supply Chain Dynamics

The global supply chain for methenamine hippurate faces several challenges:

• Raw Material Price Volatility: Fluctuations in formaldehyde and ammonia prices impact API production costs.[16]

• Regulatory Stringency: Increasing inspection standards necessitate rigorous quality controls, potentially constraining smaller suppliers.[17]

• Regional Manufacturing Growth: India and China are expanding capacities, reducing dependence on Western suppliers and enhancing regional supply security.[18]

• Sustainability and Environmental Concerns: Environmental regulations governing formaldehyde and ammonia emissions influence production practices, with some suppliers investing in greener technologies.[19]

Strategic Sourcing Recommendations

Stakeholders should focus on:

• Diversifying supplier networks across multiple regions to mitigate geopolitical and logistical risks.
• Prioritizing suppliers with ISO and GMP certifications.
• Establishing long-term contracts with reliable manufacturers to ensure price stability.
• Conducting periodic audits of suppliers' quality management systems.
• Staying attuned to regulatory updates impacting manufacturing standards globally.

Conclusion

The supply landscape for methenamine hippurate remains robust yet complex, shaped by raw material availability, regional manufacturing capacities, regulatory frameworks, and market demands. Key suppliers span chemical giants and emerging regional manufacturers, with a growing emphasis on quality assurance and supply chain resilience. Strategic procurement and continuous market monitoring are essential for stakeholders seeking to maintain a reliable supply of this vital urinary antiseptic.

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Key Takeaways

• Global suppliers of methenamine hippurate encompass leading chemical companies providing raw materials and specialized pharmaceutical manufacturers delivering finished APIs and formulations.
• Regional markets, especially India, China, and the Middle East, are expanding capacity, enhancing supply resilience.
• Supply chain risks include raw material price fluctuations, regulatory compliance challenges, and environmental constraints.
• Prioritizing certifications such as GMP and ISO is critical for ensuring product quality and regulatory acceptance.
• Diversification and long-term partnerships with reputable suppliers underpin secure sourcing strategies for methenamine hippurate.

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FAQs

1. What are the primary raw materials used in methenamine hippurate production?
Formaldehyde and ammonia are the core raw materials necessary for synthesizing methenamine, which are supplied by major chemical producers like BASF and Yara International.

2. Which regions dominate the production and supply of methenamine hippurate?
Europe, North America, and Asia are leading regions, with significant manufacturing capacities developing in India and China to meet growing global demand.

3. What regulatory considerations should buyers be aware of when sourcing methenamine hippurate?
Suppliers must comply with GMP, ISO standards, and pharmacopoeial specifications (USP, EP). Regulatory audits and certifications safeguard quality and facilitate international market access.

4. Are there any notable emerging suppliers or markets in this space?
Yes, Indian and Chinese manufacturers are establishing regional capacities, offering cost-effective alternatives while maintaining quality standards.

5. How can companies ensure supply chain resilience for methenamine hippurate?
Diversify supplier bases, establish long-term contracts, verify certifications, and monitor regional geopolitical and environmental factors influencing production.

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Sources

[1] BASF Chemical Solutions, Official Website.
[2] Celanese Corporation, Product Portfolio.
[3] Lubrizol Advanced Materials, Chemical Offerings.
[4] Yara International, Ammonia Production Data.
[5] Sigma-Aldrich, Chemical Intermediates Catalog.
[6] Thermo Fisher Scientific, Chemical Supplies.
[7] Hikma Pharmaceuticals, Product Lines.
[8] Rottapharm, API Manufacturing Capabilities.
[9] Cambridge Isotope Laboratories, Isotope Standard Providers.
[10] LGM Pharma, API Bulk Suppliers.
[11] Shenzhen Aoke Biotechnology, Chinese API Manufacturer.
[12] VACSERA, Regional API Production.
[13] Kusum Pharma, Indian API Producer.
[14] Bendiner & Co., Contract Manufacturing.
[15] Sinthesis Pharma, Formulation Providers.
[16] MarketWatch Reports on Raw Material Pricing.
[17] WHO and EMA Compliance Guidelines.
[18] Industry Reports on Indian and Chinese Pharmaceutical Manufacturing.
[19] Green Chemistry Initiatives in Chemical Manufacturing.