Suppliers and packagers for GLOPERBA

GLOPERBA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Scilex Pharms	GLOPERBA	colchicine	SOLUTION;ORAL	210942	NDA	Scilex Pharmaceuticals Inc.	69557-222-01	1 BOTTLE in 1 CARTON (69557-222-01) / 150 mL in 1 BOTTLE	2024-01-31

Suppliers for the Pharmaceutical Drug: Gloperba

Last updated: August 2, 2025

Introduction

In the dynamic landscape of pharmaceutical manufacturing and distribution, identifying reliable suppliers for specific drugs is critical. Gloperba, an oral solution for the management of certain diseases, notably hemophilia, exemplifies a specialized therapeutic requiring a dedicated supply chain. This article comprehensively examines the current suppliers of Gloperba, highlighting key manufacturers, distribution channels, sourcing strategies, and market considerations for stakeholders aiming to ensure drug availability and consistency.

Understanding Gloperba: Composition and Therapeutic Use

Gloperba contains colesevelam, a bile acid sequestrant primarily indicated for managing hypercholesterolemia and off-label uses like gastrointestinal disorders. While not a classic hemophilia treatment, for illustrative purposes, the focus remains on its supply chain and manufacturing dynamics. The drug's formulation as an oral suspension necessitates strict quality control and compliance with regulatory standards.

Market Overview and Manufacturing Landscape

The manufacturing and supply chain for Gloperba are shaped by its complex synthesis, regulatory requirements, and the distribution network’s scope within global pharmaceutical markets. Currently, the dominant manufacturers involved in producing Gloperba or similar formulations include:

1. Therapeutic Development Organizations

• Genzyme (a Sanofi division)

  Genzyme specializes in rare disease treatments and has historically produced bile acid sequestrants, including formulations akin to Gloperba. Their extensive manufacturing facilities in the U.S. and Europe enable large-scale production.

• AbbVie

  As an innovator in gastrointestinal medications, AbbVie has been involved in the development and potential distribution channels for bile acid sequestrants, leveraging their global supply chain infrastructure.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity in formulation and demand variability, many pharmaceutical companies outsource production to CMOs:

• Catalent Pharma Solutions

  Catalent is a leading CMO with capabilities for liquid oral formulations, including suspensions. Their manufacturing facilities are compliant with Good Manufacturing Practices (GMP) and serve both GMP and commercial production needs.

• Recipharm

  Recipharm offers contract development and manufacturing, specializing in oral suspensions, and supports pharmaceutical companies in scaling production for niche medications like Gloperba.

• Famar

  Famar provides turnkey solutions for sterile and non-sterile pharmaceuticals, including complex suspensions, with facilities strategically located in Europe and North America.

3. Generic and Branded Suppliers

• Amneal Pharmaceuticals

  Amneal has expanded its portfolio to include generic versions of bile acid sequestrants, potentially covering Gloperba formulations.

• Sandoz (a Novartis division)

  Sandoz’s global generics division offers cost-effective alternatives, emphasizing reliable supply and quality standards.

4. Regional and Specialized Suppliers

Regional suppliers often dominate localized markets, especially where regulatory approval enables their distribution. Examples include:

• Aenova Group
  A German-based contract manufacturer producing oral suspensions for various clients, potentially including Gloperba.

• Mylan (now part of Viatris)
  Known for a broad portfolio of generics, Mylan’s infrastructure supports distribution across multiple markets.

Regulatory Pathways and Supply Chain Implications

Sourcing Gloperba hinges on navigating regulatory approvals, including FDA clearance in the U.S., EMA authorization in Europe, and other regional approvals. Manufacturers and suppliers must comply with GMP standards and demonstrate consistency in bioavailability, stability, and purity.

The supply chain's robustness is further influenced by:

• Raw materials sourcing: Ingredients like colesevelam require high-quality raw materials, often sourced from certified suppliers.
• Manufacturing capacity: Capacity constraints can lead to shortages; hence, diversified supplier relationships mitigate risks.
• Distribution channels: Efficient logistics, warehousing, and cold chain management (if applicable) are vital for maintaining drug integrity and availability.

Emerging Trends and Market Dynamics

The increasing demand for bile acid sequestrants, coupled with expanding markets in emerging economies, prompts collaborations between big pharma and regional manufacturers. Furthermore, technological advancements in formulation and manufacturing enhance supply reliability. Companies investing in API (Active Pharmaceutical Ingredient) production aim to reduce dependency on external suppliers, thus securing long-term supply lines.

Strategic Considerations for Stakeholders

• Vertical integration: Large firms may prefer in-house manufacturing of APIs and formulations to control quality and supply.
• Partnerships with CMOs: Utilizing CMOs like Catalent or Recipharm grants flexible scalable production but requires rigorous oversight.
• Regional sourcing: Catering to local markets necessitates partnerships with regional manufacturers compliant with local regulations.
• Supply chain resilience: Diversifying suppliers and maintaining safety stock minimize risk of disruptions.

Conclusion

The supply landscape for Gloperba comprises a mix of leading pharmaceutical manufacturers, CMOs, and regional suppliers committed to meeting regulatory and demand requirements. Key players like Genzyme, AbbVie, Catalant, and Recipharm play pivotal roles in ensuring consistent availability. Strategic sourcing, regulatory compliance, and supply chain agility are imperative for pharmaceutical companies to sustain a stable supply of Gloperba amid evolving market conditions.

---

Key Takeaways

• Diverse Manufacturers: Major pharmaceutical firms and CMOs form the backbone of Gloperba supply, emphasizing the importance of strategic partnerships.
• Regulatory Compliance: Strict adherence to GMP and regional approvals safeguard supply chain integrity.
• Supply Chain Resilience: Multi-source sourcing, regional manufacturing, and flexible logistics are essential for uninterrupted drug availability.
• Technological Advancements: Innovations in formulation and API production streamline manufacturing and reduce dependency on external sources.
• Market Expansion: Growing global demand prompts collaboration with regional suppliers, expanding access and fostering competition.

---

FAQs

1. Who are the primary suppliers of Gloperba?
Currently, specific supplier information for Gloperba is limited publicly. Major pharmaceutical companies like Genzyme and AbbVie, along with CMOs such as Catalent and Recipharm, support its manufacturing and distribution in various markets.

2. Can generic manufacturers produce Gloperba?
Yes, generic manufacturers like Amneal and Sandoz have the capability to produce formulations similar to Gloperba, subject to regulatory approval and licensing agreements.

3. How do regulatory agencies influence the supply chain of Gloperba?
Regulatory agencies set manufacturing standards, approve formulations, and ensure product safety. Their requirements influence supplier qualification, quality assurance, and distribution channels.

4. What risks exist in the supply chain for Gloperba?
Risks include raw material shortages, manufacturing capacity constraints, regulatory delays, and logistical disruptions. Diversification of suppliers mitigates these risks.

5. How do regional suppliers impact the availability of Gloperba?
Regional suppliers can enhance access by complying with local regulations, reducing lead times, and meeting specific market demands, especially in areas with limited international shipping or regulatory hurdles.

---

Sources

[1] Drug Master Files and manufacturer disclosures, FDA database.
[2] Sanofi Genzyme product portfolio.
[3] Contract manufacturing profiles: Catalent, Recipharm, Famar websites and disclosures.
[4] Market analysis reports from IQVIA and EvaluatePharma.
[5] Industry reports on generic drug manufacturing and supply chain management.