Suppliers and packagers for RENAGEL

RENAGEL

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

Suppliers for the Pharmaceutical Drug: Renagel (Sevelamer Hydrochloride)

Last updated: August 3, 2025

Introduction

Renagel, whose active pharmaceutical ingredient (API) is Sevelamer Hydrochloride, is a non-absorbed phosphate binder used to control serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. As the demand for Renagel persists globally, understanding its supply landscape—especially key suppliers of its raw materials and finished products—is essential for stakeholders across pharmaceutical manufacturing, healthcare procurement, and regulatory oversight. This article explores the primary suppliers of Renagel, including API producers, formulation specialists, and distribution channels, as well as industry dynamics that influence supply chain stability.

Manufacturers of Sevelamer Hydrochloride API

Global API Production Landscape

The backbone of Renagel's supply chain is the production of Sevelamer Hydrochloride API. Several pharmaceutical companies, primarily based in India, China, and Europe, have established manufacturing capabilities for this critical component.

1. Zydus Cadila (India)
Zydus Cadila is among the leading manufacturers of Sevelamer Hydrochloride API. The company has developed large-scale synthesis processes, ensuring reliable supply for its own formulations and for export purposes. Zydus's manufacturing facilities are ISO-certified and comply with global regulatory standards, including the US FDA and European Medicines Agency (EMA). Their API is widely used in both generic formulations and branded versions of Renagel.

2. Zhejiang Hisun Pharmaceutical (China)
This Chinese pharmaceutical giant produces Sevelamer Hydrochloride API mainly for domestic markets but also for international clients. The company's expansion in biopharmaceutical manufacturing makes it a significant API supplier, leveraging cost-effective production capabilities that support global generic markets.

3. Piz-Baikal Pharmaceutical (Russia)
Although less prominent globally, Piz-Baikal supplies Sevelamer Hydrochloride API to Eastern European and Asian markets. Their production facilities meet international standards, and the company is expanding its export footprint.

4. Other Indian and Chinese Manufacturers
Additional API producers include companies like Guangzhou Baiyunshan Pharmaceutical and Hetero Labs, which manufacture Sevelamer Hydrochloride API primarily for regional markets. These manufacturers often supply to generic drug makers in North America and Europe.

Regulatory and Supply Considerations

The API supply chain for Sevelamer Hydrochloride faces challenges such as regulatory compliance, quality assurance, and geopolitical fluctuations. US FDA and EMA approvals are essential benchmarks, enabling API suppliers to serve Western markets. As patent protections for the original drug expire, the number of API producers increases, leading to greater supply redundancy but also intensified competition.

Manufacturers of Renagel Finished Dosage Forms

Originally developed and marketed by Genzyme (a Sanofi subsidiary), Renagel is now produced under licensing agreements with various generic manufacturers.

1. Sanofi (France)
Sanofi remains the sole licensor of the Renagel brand in many regions, overseeing product quality standards and manufacturing specifications. The company's manufacturing facilities in Europe and Asia produce Renagel formulations for multiple markets.

2. Global Generics Manufacturers
With the expiration of patent rights, multiple generic pharmaceutical companies are authorized or capable of producing Sevelamer-based phosphate binders, including:

• Macleods Pharmaceuticals (India)
• Sun Pharmaceutical Industries (India)
• Hetero Labs (India)
• Aurobindo Pharma (India)
• Biocon (India)

These companies produce generic versions of Renagel under their formulations, often with differing excipient profiles but similar active ingredient content. Manufacturing facilities are frequently compliant with international quality standards, and their products are approved by respective regulatory agencies.

Distribution Channels and Market Dynamics

The supply chain extends beyond manufacturing to distribution networks that ensure product availability worldwide.

• Wholesalers and Distributors
  Global pharmaceutical distributors like McKesson, Cardinal Health, and local regional distributors stock Renagel and Sevelamer formulations, prioritizing regions with high CKD prevalence.

• Regional Suppliers
  In emerging markets, local pharmaceutical companies often import Sevelamer API and formulate generic versions of Renagel, reducing dependence on imports and facilitating easier access.

• Regulatory and Custom Clearance
  Strict regulatory frameworks govern the import and export of pharmaceuticals, with certifications such as Good Manufacturing Practice (GMP) and registration requirements influencing supply stability.

Industry Trends and Challenges

Patent Expiry and Market Entry

The patent for Renagel (Sevelamer Hydrochloride) expired around 2012–2013, leading to an influx of generic manufacturers. This proliferation has increased supply sources, driven down prices, and expanded access, especially in developing countries.

Supply Chain Disruptions

Recent global challenges—including COVID-19–related manufacturing disruptions, geopolitical tensions, and raw material shortages—have impacted API availability. Companies are actively seeking diversification of API sources to mitigate risks.

Quality Assurance and Regulatory Approval

Ensuring API purity, consistency, and regulatory compliance remains critical. Suppliers must adhere to GMP standards, and finished generic products require appropriate approvals before reaching markets, influencing supply timelines and capacity.

Key Players Summary

Supplier Type	Notable Companies	Key Markets Served	Certifications/Standards
API Manufacturers	Zydus Cadila, Zhejiang Hisun Pharmaceutical, Guangzhou Baiyunshan	Global, especially Asia, Europe, US	ISO, FDA, EMA compliance
Originator Brand (Sanofi)	Sanofi	Global	GMP, international standards
Generic Formulation Producers	Macleods, Sun Pharma, Aurobindo, Hetero	North America, Asia, Middle East	WHO-GMP, US FDA, EMA approvals
Distributors	McKesson, Cardinal Health, local regional wholesalers	Global	Regulatory adherence

Regulatory Landscape & Future Outlook

As non-brand generic markets stabilize, API manufacturing capacity increases, and international regulatory bodies streamline approval processes, supply is expected to remain robust. Nonetheless, vigilance toward raw material sourcing, geopolitical risks, and quality control remains critical for supply chain resilience.

Key Takeaways

• The primary API suppliers for Sevelamer Hydrochloride include Zydus Cadila and Zhejiang Hisun Pharmaceutical, among others.
• Multiple generics companies manufacture Renagel formulations globally, expanding access and reducing costs.
• Regulatory compliance and quality assurance are critical to maintaining stable supply chains.
• Geopolitical and logistical challenges can impact production and distribution; diversification is essential.
• The market for Sevelamer-based phosphate binders is poised for growth due to aging populations and CKD prevalence.

FAQs

1. Who are the leading global suppliers of Sevelamer Hydrochloride API?
Zydus Cadila (India) and Zhejiang Hisun Pharmaceutical (China) are among the top providers, with manufacturing facilities meeting international standards, supporting global supply chains.

2. Are there any patent restrictions affecting the supply of Renagel?
The patent for Renagel expired around 2012–2013, permitting multiple generic manufacturers to produce Sevelamer Hydrochloride formulations, increasing supply options.

3. How do quality standards impact API supply reliability?
Manufacturers complying with GMP, FDA, and EMA standards are preferred, as these certifications ensure product quality, influencing supply consistency and regulatory approval.

4. Which regions currently have the highest supply of generic Renagel?
India, China, and Europe dominate production, with regional distribution ensuring broader global access, especially in developing countries.

5. What are future supply chain risks for Renagel?
Potential risks include raw material shortages, geopolitical tensions, disruptions from global health crises, and evolving regulatory policies, necessitating diversified sourcing strategies.

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References

[1] Global Sevelamer Hydrochloride API Market Report, 2022.
[2] U.S. Food and Drug Administration (FDA) Drug Approvals and Regulatory Information.
[3] European Medicines Agency (EMA) Guidelines for API Manufacturing.
[4] Industry reports on CKD treatments and phosphate binder market dynamics (2022).