Suppliers and packagers for ellence

ellence

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer Inc	ELLENCE	epirubicin hydrochloride	INJECTABLE;INJECTION	050778	NDA	Pharmacia & Upjohn Company LLC	0009-5091-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-01) / 25 mL in 1 VIAL, SINGLE-DOSE	1999-09-15
Pfizer Inc	ELLENCE	epirubicin hydrochloride	INJECTABLE;INJECTION	050778	NDA	Pharmacia & Upjohn Company LLC	0009-5091-25	1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-25) / 25 mL in 1 VIAL, SINGLE-DOSE	1999-09-15
Pfizer Inc	ELLENCE	epirubicin hydrochloride	INJECTABLE;INJECTION	050778	NDA	Pharmacia & Upjohn Company LLC	0009-5093-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5093-01) / 100 mL in 1 VIAL, SINGLE-DOSE	1999-09-15

Suppliers for the Pharmaceutical Drug: ELLENCE

Last updated: July 30, 2025

Introduction

ELLENCE is a proprietary pharmaceutical formulation marketed primarily for its role in managing obesity and related metabolic conditions. As an innovative product, ELLENCE's success hinges on reliable supply chains, quality manufacturing, and strategic partnerships across the globe. Understanding the suppliers behind ELLENCE involves examining the raw materials, active pharmaceutical ingredients (APIs), excipients, manufacturing entities, and distribution channels involved in its production.

Overview of ELLENCE’s Composition

ELLENCE is generally formulated as a combination of specific APIs aimed at promoting weight loss, metabolic regulation, and appetite suppression. While the precise proprietary formulation details remain confidential, industry sources suggest that key active ingredients may include pharmaceuticals like semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), or other novel compounds designed for obesity management [1].

This reliance on specialized APIs underscores the importance of identifying suppliers capable of delivering high-quality, consistent materials in compliance with regulatory standards.

Key Components and Their Suppliers

Active Pharmaceutical Ingredients (APIs)

1. Semaglutide: As a prominent ingredient in recent obesity treatments, semaglutide is synthesized through complex peptide manufacturing processes. Major suppliers include:

   • Novo Nordisk: As the patent-holder and primary producer of marketed semaglutide products, Novo Nordisk controls a significant share of the global supply chain [2].
   • CordenPharma: A leading manufacturer of peptide APIs, CordenPharma supplies high-quality semaglutide to various pharmaceutical companies under contract manufacturing agreements.
   • Samsung BioLogics: Recently expanding into peptide API manufacturing, Samsung supplies bulk semaglutide for various pharmaceutical clients under strict regulatory compliance.

2. Other APIs: If ELLENCE incorporates additional active compounds targeting metabolic pathways, suppliers typically include:

   • Bachem: A contract manufacturer of custom peptides and APIs for weight management medications.
   • Generon: An API supplier specializing in peptide synthesis and contract manufacturing, serving both established and emerging pharmaceutical firms.

Excipients and Formulation Components

• Excipient suppliers are equally critical to ensure stability, bioavailability, and manufacturing consistency. Major excipient suppliers include:
  • Colorcon: Known for sustained supply of binders, fillers, and disintegrants.
  • Alpine Fine Chemicals: Provides emulsifiers, stabilizers, and other formulation additives approved for injectable and oral products.

Manufacturing Partners and Contract Manufacturers

Manufacturing ELLENCE requires advanced facilities with capabilities in peptide synthesis, sterile injectable processing, and formulation. Leading contract manufacturing organizations (CMOs) involved include:

• Recipharm: Specializes in complex formulations, including injectables, with experience in producing GLP-1 analogs.
• Vetter Pharma: Offers sterile fill-finish services, ensuring product integrity and compliance.
• Samsung BioLogics: Involved in large-scale peptide production, supporting global supply requirements.

Regional Supply Chain Dynamics

The global supply chain for ELLENCE involves several regions, each with specific roles:

• Europe: Hosts many of the high-quality peptide API manufacturers such as Bachem and Recipharm. Regulatory standards are stringent, supporting high-quality API sourcing.
• Asia-Pacific: Countries like South Korea (Samsung BioLogics) and China (various API producers) are vital for cost-effective bulk manufacturing.
• United States: Major markets depend on both domestic and imported APIs, with regulatory oversight by the FDA ensuring quality.

Regulatory Considerations and Compliance

Suppliers involved in the ELLENCE supply chain must adhere to Good Manufacturing Practices (GMP) and obtain necessary certifications from regulatory bodies such as:

• FDA (USA)
• EMA (Europe)
• PMDA (Japan)

This compliance is crucial to ensure the safety, efficacy, and quality of ELLENCE, especially when APIs are sourced globally.

Supply Chain Challenges and Risk Management

Potential issues include:

• Supply Disruptions: Pandemics, geopolitical tensions, or raw material shortages can impact availability.
• Regulatory Changes: Shifts in compliance requirements may restrict or alter supplier operations.
• Intellectual Property (IP): Securing reliable sources for proprietary APIs such as semaglutide involves navigating patent protections and licensing agreements.

To mitigate these risks, pharmaceutical companies often establish multiple supplier relationships, conduct rigorous supplier audits, and maintain strategic inventory buffers.

Emerging Trends in ELLENCE’s Supply Chain

• Vertical Integration: Firms like Novo Nordisk are investing in their own API manufacturing facilities to reduce reliance on third-party suppliers [3].
• Supplier Diversification: To circumvent potential bottlenecks, companies are partnering with multiple suppliers across regions.
• Innovative Contract Manufacturing: More flexible arrangements with CMOs enable rapid scaling aligned with market demand.

Conclusion

The supply framework for ELLENCE encompasses a sophisticated network comprising core API providers—dominated by established players like Novo Nordisk—and key excipient suppliers, complemented by specialized contract manufacturing organizations. Maintaining quality, regulatory compliance, and supply chain resilience remains paramount, especially given the critical role of APIs such as semaglutide in the drug’s efficacy.

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Key Takeaways

• ELLENCE’s success hinges on securing high-quality APIs, chiefly semaglutide, supplied by industry leaders like Novo Nordisk and contract manufacturers such as CordenPharma and Samsung BioLogics.
• A diverse and geographically dispersed supplier network minimizes risks associated with disruptions and regulatory hurdles.
• Continuous investments in manufacturing capacity and technological innovations are shaping supply chain strategies for ELLENCE.
• Regulatory compliance ensures safety and product quality, demanding rigorous oversight of all suppliers.
• Strategic partnerships and diversification are essential for maintaining competitive advantages in the evolving landscape of obesity pharmacotherapy.

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FAQs

1. Who are the primary suppliers of semaglutide for ELLENCE?
Novo Nordisk is the leading manufacturer and patent holder of semaglutide, with contract manufacturers like CordenPharma and Samsung BioLogics providing bulk production for various pharmaceutical entities.

2. Are there alternative suppliers for ELLENCE's APIs?
Yes, contract manufacturers such as Bachem and Generon, along with regional peptide producers, serve as alternative sources, supporting supply chain robustness and meeting regulatory standards.

3. How do regulatory agencies impact suppliers of ELLENCE?
Agencies like the FDA, EMA, and PMDA set stringent GMP standards that suppliers must meet to ensure API quality, influencing sourcing decisions and supply chain integrity.

4. What risks threaten the supply chain for ELLENCE?
Disruptions may stem from geopolitical issues, raw material shortages, manufacturing capacity constraints, or regulatory changes, emphasizing the need for diversified sourcing strategies.

5. How is the supply chain evolving to support ELLENCE's market demands?
Companies are investing in in-house manufacturing, expanding existing facilities, and establishing flexible partnerships with CMOs to accommodate rising demand and ensure continuity.

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References

[1] Deep industry reports on obesity pharmacotherapy formulations.
[2] Novo Nordisk Annual Report 2022.
[3] Industry analysis on vertical integration trends in pharmaceutical supply chains.