Suppliers and packagers for COLESTIPOL HYDROCHLORIDE

COLESTIPOL 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
Impax Labs	COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	GRANULE;ORAL	077277	ANDA	Amneal Pharmaceuticals of New York LLC	0115-5212-18	30 SUSPENSION in 1 CARTON (0115-5212-18)	2006-05-02
Impax Labs	COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	GRANULE;ORAL	077277	ANDA	Amneal Pharmaceuticals of New York LLC	0115-5212-29	90 SUSPENSION in 1 CARTON (0115-5212-29)	2006-05-02
Impax Labs	COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	GRANULE;ORAL	077277	ANDA	Amneal Pharmaceuticals of New York LLC	0115-5213-02	100 SUSPENSION in 1 BOTTLE (0115-5213-02)	2006-05-02
Ani Pharms	COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	TABLET;ORAL	216517	ANDA	ANI Pharmaceuticals, Inc.	62559-395-12	120 TABLET, FILM COATED in 1 BOTTLE (62559-395-12)	2023-05-15

Suppliers for the Pharmaceutical Drug: Colestipol Hydrochloride

Last updated: July 30, 2025

Introduction

Colestipol hydrochloride is a bile acid sequestrant primarily prescribed to lower elevated LDL cholesterol levels, particularly in patients unresponsive to lifestyle modifications and other lipid-lowering agents. Its utility extends to managing hyperlipidemia and preventing cardiovascular complications associated with high cholesterol. The global demand for colestipol hydrochloride necessitates a robust supply chain comprised of various suppliers—including active pharmaceutical ingredient (API) producers, finished drug manufacturers, and distribution entities. This report delineates the current landscape of suppliers specific to colestopil hydrochloride, analyzing their geographic distribution, market share, regulatory status, manufacturing capacity, and strategic positioning within the pharmaceutical supply chain.

Active Pharmaceutical Ingredient (API) Suppliers

Major API Manufacturers

The foundation of colestipol hydrochloride supply hinges on the availability of high-quality API producers. While the API для colestipol hydrochloride is synthesized via complex chemical processes, several manufacturers are recognized for producing GMP-compliant API on a global scale.

1. Cambridge Major Laboratories (now part of DATEC PhaRma)

   • Location: United States
   • Overview: Known for manufacturing a broad spectrum of APIs, Cambridge Major has been involved historically in producing colestipol hydrochloride API for various pharmaceutical companies. Their advanced synthesis capabilities and strong regulatory compliance benchmarks make them a key player in the North American market.

2. Huadong Medicine Co., Ltd.

   • Location: China
   • Overview: As a leading Chinese pharmaceutical conglomerate, Huadong supplies a significant volume of APIs, including colestipol hydrochloride, with competitive pricing and large-scale manufacturing facilities that are GMP-certified. Their focus on complying with international standards positions them as a strategic API supplier in Asia.

3. Zhejiang Xianju Pharmaceutical Co., Ltd.

   • Location: China
   • Overview: Specializes in chemical intermediates and APIs, including polymeric sequestrants like colestipol hydrochloride. Their capacity to produce high-purity API and expand export operations makes them a notable supplier for generic drug manufacturers.

4. Shandong Renfund Pharmaceutical Co., Ltd.

   • Location: China
   • Overview: Focused on cardiovascular and central nervous systems drugs, Renfund manufactures colestipol hydrochloride API at large capacities. Their strategic partnerships with multinational pharmaceutical firms bolster their presence in the global API supply chain.

Regulatory Considerations

API suppliers must adhere to stringent regulatory standards, including cGMP (current Good Manufacturing Practice) compliance and approval by major health authorities such as the U.S. FDA, EMA, and China FDA. Certification ensures that the APIs meet purity, consistency, and safety standards essential for pharmaceutical formulations.

Finished Dosage Formulators and Manufacturers

Established Pharmaceutical Companies

Colestipol hydrochloride is predominantly marketed by generic pharmaceutical firms and specialty drug manufacturers.

1. Fresenius Kabi

   • Location: Germany
   • Market Role: Produces colestipol hydrochloride in tablet and powder form, serving primarily European markets. Their robust quality systems and global distribution network make them a prominent supplier.

2. Bausch Health Companies Inc.

   • Location: Canada/United States
   • Market Role: Markets colestipol hydrochloride under brand names such as Colestid. Their extensive distribution channels and biosimilar development pipelines reinforce their market position.

3. Ipsen Pharma

   • Location: France
   • Market Role: Although primarily focused on other therapeutic areas, Ipsen manufactures generic versions of colestipol hydrochloride for regional markets, emphasizing quality standards consistent with European regulations.

4. Teva Pharmaceutical Industries Ltd.

   • Location: Israel
   • Market Role: One of the world’s largest generic drug manufacturers, Teva produces colestipol hydrochloride formulations distributed widely across North America and emerging markets.

Market Dynamics

The procurement of finished formulations depends largely on regional regulatory approval, manufacturing capacity, and patent exclusivity periods. Because colestipol hydrochloride patents have expired in many jurisdictions, generic formulations dominate supply, resulting in price competition and diversified sourcing options.

Distributors and Logistics

Distributors play an integral role in bridging manufacturers with healthcare providers.

• McKesson Corporation
• Cardinal Health
• AmerisourceBergen

These entities ensure the timely supply of colestipol hydrochloride to hospitals, pharmacies, and specialty clinics, emphasizing quality assurance and regulatory compliance during transportation and storage.

Strategic Considerations for Stakeholders

Supply Chain Robustness

Given the critical therapeutic role of colestipol hydrochloride, manufacturers seek diversified sourcing strategies—engaging multiple API suppliers and geographical regions—to mitigate supply disruptions and price fluctuations.

Regulatory Compliance and Quality Assurance

Suppliers’ compliance with international standards influences their market access, especially for age-restricted or sensitive patient populations.

Market Trends and Strategic Partnerships

Collaborations between API producers and finished-formulation manufacturers safeguard supply continuity, foster innovation, and expand market reach. Suppliers often engage in joint ventures or licensing agreements to enhance manufacturing capacity and enter emerging markets.

Conclusion

The global supply landscape for colestipol hydrochloride features a blend of reputable API producers primarily based in China and the United States, complemented by established finished formulation manufacturers across Europe and North America. Ensuring supply chain resilience necessitates strategic partnerships, adherence to regulatory standards, and diversified sourcing. Stakeholders should monitor geopolitical developments, regulatory shifts, and technological advances affecting these suppliers’ operations to sustain uninterrupted availability.

Key Takeaways

• Diverse API Suppliers: Major API producers include Chinese firms like Huadong Medicine and Zhejiang Xianju Pharmaceutical, alongside US-based Cambridge Major, providing scalable and GMP-compliant options.
• Manufacturers’ Market Focus: European and North American firms dominate the finished dosage form market, with names like Fresenius Kabi and Teva maintaining key roles.
• Regulatory Vigilance: Continuous adherence to GMP and certifications from global agencies underpin supplier credibility.
• Supply Chain Risks: Geopolitical, regulatory, or production disruptions necessitate multi-sourcing strategies.
• Market Dynamics: The generic status of colestipol hydrochloride fosters competitive pricing but underscores the importance of quality assurance for sustained supply.

FAQs

1. Who are the leading API suppliers for colestipol hydrochloride?
Chinese manufacturers such as Huadong Medicine and Zhejiang Xianju Pharmaceutical are prominent, alongside US-based Cambridge Major Laboratories, offering GMP-compliant API for global supply.

2. Are there major regulatory hurdles for suppliers of colestipol hydrochloride?
Yes, suppliers must meet cGMP standards and obtain approvals from agencies like the FDA, EMA, and Chinese NMPA, ensuring safety, consistency, and quality of their APIs and finished products.

3. What factors influence the pricing of colestipol hydrochloride?
Market competition among generic manufacturers, raw material costs, regulatory compliance costs, and geopolitics impact pricing and supply stability.

4. How do finished drug manufacturers secure supply continuity?
By establishing relationships with multiple API suppliers, maintaining inventory buffers, and complying with international quality standards.

5. What is the outlook for the colestipol hydrochloride supply chain?
The outlook remains stable, with ongoing generic production and expanding market demand. Emphasizing supplier diversification and regulatory adherence will be essential to managing future supply risks.

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References

1. National Center for Biotechnology Information. “Colestipol Hydrochloride.” PubChem Compound Summary.
2. U.S. Food and Drug Administration. “Inactive Ingredient Search for Approved Drugs.”
3. GlobalData Healthcare. “Pharmaceutical Market Reports on Lipid-Lowering Agents.”
4. European Medicines Agency. “Guidelines on Good Manufacturing Practices (GMP).”
5. Pharmaceutical Technology. “Supply Chain Management Best Practices in API Sourcing.”