Suppliers and packagers for generic pharmaceutical drug: SEVELAMER HYDROCHLORIDE

SEVELAMER HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179	NDA AUTHORIZED GENERIC	Sanofi-Aventis U.S. LLC	0955-1048-18	180 TABLET, FILM COATED in 1 BOTTLE (0955-1048-18)	2019-02-13
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179	NDA AUTHORIZED GENERIC	Sanofi-Aventis U.S. LLC	0955-5902-18	180 TABLET, FILM COATED in 1 BOTTLE (0955-5902-18)	2019-02-13
Aurobindo Pharma Ltd	SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	212599	ANDA	Aurobindo Pharma Limited	59651-087-36	360 TABLET, FILM COATED in 1 BOTTLE (59651-087-36)	2023-07-11

Suppliers for the Pharmaceutical Drug: Sevelamer Hydrochloride

Last updated: July 29, 2025

Introduction

Sevelamer hydrochloride is a non-absorbed, phosphate-binding polymer used primarily to manage hyperphosphatemia in patients with chronic kidney disease (CKD), particularly those on dialysis. As a vital component in renal care, its supply chain and manufacturing sources are critical for healthcare providers and pharmaceutical companies. This article provides an in-depth analysis of the key suppliers for sevelamer hydrochloride, examining manufacturing players, global market dynamics, and strategic considerations that influence availability and pricing.

Overview of Sevelamer Hydrochloride

Sevelamer hydrochloride functions by binding phosphate in the gastrointestinal tract, thereby mitigating serum phosphate levels in CKD patients. Its unique mechanism and regulatory approval status make it a specialized drug with a limited pool of manufacturers. The initial breakthrough in production came with innovative biotech firms, with subsequent licensing and commercialization expanding globally.

Major Manufacturers and Suppliers

1. Global Pharmaceutical Giants

a. Renvela® (by Sanofi)

Sanofi has dominated the sevelamer market, primarily with its branded formulations, Renvela® (sevelamer carbonate) and, historically, Sevelamer hydrochloride. Sanofi’s manufacturing plants in Europe and North America produce high-purity sevelamer hydrochloride. The company's extensive distribution channels ensure widespread availability, especially in North America and Europe.

b. Genzyme (a Sanofi subsidiary)

Genzyme initially developed sevelamer products and played an important role in early market penetration. Following Sanofi’s acquisition of Genzyme, manufacturing and distribution processes have been unified under Sanofi’s umbrella.

2. Contract Manufacturing Organizations (CMOs)

Third-party manufacturers have become increasingly prominent, especially as patent protections evolve and generic competition emerges.

a. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

Zhejiang Hisun is a significant generic pharmaceutical manufacturer producing sevelamer hydrochloride in bulk. Its facilities are compliant with GMP standards, and it supplies both domestic and international markets. Their strategic manufacturing capacity expansion has been geared towards meeting global demand.

b. Zhejiang Silver Eye Health Industry Co., Ltd.

This Chinese firm specializes in producing active pharmaceutical ingredients (APIs) and formulations, including sevelamer hydrochloride, with a focus on cost-effective production for export.

c. Partnered Generic Manufacturers

Global pharmaceutical companies such as Mylan (now Part of Viatris) and Teva Pharmaceuticals have entered the market with generic versions, sourcing APIs from regional manufacturers like Zhejiang Hisun or other Chinese and Indian API producers.

3. Indian API Manufacturers

India is a major hub for pharmaceutical APIs due to low manufacturing costs and large-scale production capacity.

a. Dr. Reddy’s Laboratories

While primarily manufacturing APIs for diverse drugs, Dr. Reddy’s has the capacity and expertise to produce sevelamer hydrochloride, with supply agreements in place for both domestic use and export.

b. Laurus Labs

Laurus Labs is investing significantly in phosphate-binding agents, enhancing its pipeline to include sevelamer hydrochloride as part of its portfolio, focusing on high-volume production at competitive costs.

4. Emerging and Regional Suppliers

Given the increasing demand and geographic expansion, several regional players in Asia, South America, and Eastern Europe have initiated API production lines for sevelamer hydrochloride, often catering to local markets with variable regulatory standards.

Market Dynamics and Regulatory Considerations

Regulatory Approval

Suppliers must navigate complex regulatory pathways to market sevelamer hydrochloride. While branded products like Renvela® have established regulatory clearances (e.g., FDA, EMA), generic manufacturers need to secure Abbreviated New Drug Applications (ANDAs) and meet bioequivalence standards.

Licensing Agreements and Patent Expirations

The original patent for sevelamer hydrochloride has expired in multiple regions, leading to increased generic competition. Sanofi controls the rights for certain formulations (sevelamer carbonate), but the hydrochloride form is widely accessible from multiple manufacturers.

Supply Chain Risks

Disruptions in Chinese and Indian manufacturing hubs pose risks for the global supply of APIs. Geopolitical tensions, COVID-19 related manufacturing restrictions, and regulatory hurdles require manufacturers and buyers to develop diversified sourcing strategies.

Strategic Insights for Stakeholders

• Pharmaceutical Companies: Should secure supply agreements with established API manufacturers such as Zhejiang Hisun or Indian generics to ensure consistent supply, especially amid geopolitical uncertainties.
• Healthcare Providers: Need to assess the availability and price variations between branded and generic formulations, considering regional supplier options.
• Investors and Traders: Opportunities exist in companies investing in API manufacturing capacity expansions or forming strategic partnerships with regional suppliers in China and India.

Conclusion

The supply landscape for sevelamer hydrochloride is characterized by a mix of large pharmaceutical corporations, regional API producers, and generic manufacturers. Sanofi remains the dominant supplier for branded formulations, but an expanding generic market driven by Chinese and Indian manufacturers enhances global access. Ensuring supply chain robustness, complying with regulatory standards, and managing geopolitical risks are vital for stakeholders involved in the production, distribution, and procurement of sevelamer hydrochloride.

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Key Takeaways

• Leading Suppliers: Sanofi retains primary control over branded sevelamer hydrochloride, with Chinese firms like Zhejiang Hisun and Indian companies such as Dr. Reddy’s and Laurus Labs providing bulk APIs.
• Market Expansion: Patent expirations have facilitated increased generic competition, improving accessibility but also introducing supply variability risks.
• Supply Chain Risks: Asian manufacturing hubs are critical nodes; geopolitical and health crises can impact global availability.
• Regulatory Barriers: Entry for new suppliers depends on rigorous bioequivalence and GMP compliance, influencing the proliferation of regional providers.
• Strategic Sourcing: Buyers should diversify sourcing and build relationships with multiple manufacturers to mitigate supply disruptions.

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FAQs

1. Who are the main global suppliers of sevelamer hydrochloride?

Sanofi is the primary supplier through its branded product, Renvela®. Additionally, Chinese companies like Zhejiang Hisun Pharmaceutical and Indian manufacturers such as Dr. Reddy’s Laboratories serve as key bulk API providers.

2. Are there generic versions of sevelamer hydrochloride available?

Yes, several generic formulations are available, primarily sourced from Chinese and Indian manufacturers, following patent expirations and regional regulatory approvals.

3. How does the supply chain impact drug availability globally?

Disruptions at Asian manufacturing sites—due to geopolitical issues, pandemics, or regulatory challenges—can lead to shortages or price volatility in sevelamer hydrochloride.

4. What regulatory hurdles exist for new suppliers entering the market?

New entrants must secure GMP certification, demonstrate bioequivalence (for generics), and navigate complex approval processes in target markets such as the FDA, EMA, and other regional agencies.

5. What are future trends in sevelamer hydrochloride supply?

Increased capacity from Chinese and Indian API producers, coupled with potential new formulations and direct licensing agreements, are likely to shape supply stability and cost dynamics over the next several years.

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Sources:

1. [Sanofi official website]
2. [FDA Drug Approvals and Regulatory Data]
3. [Chinese pharmaceutical industry reports]
4. [Indian pharmaceutical market analyses]
5. [Global phosphate binder market research studies]