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Suppliers and packagers for firmagon
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firmagon
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201 | NDA | Ferring Pharmaceuticals Inc. | 55566-8303-1 | 1 KIT in 1 CARTON (55566-8303-1) * 4 mL in 1 VIAL, GLASS * 4.2 mL in 1 SYRINGE | 2009-03-02 |
| Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201 | NDA | Ferring Pharmaceuticals Inc. | 55566-8403-1 | 1 KIT in 1 CARTON (55566-8403-1) * 3 mL in 1 SYRINGE * 3 mL in 1 VIAL, GLASS | 2009-03-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: FIRMAGON
Introduction
FIRMAGON (degarelix) is a gonadotropin-releasing hormone (GnRH) antagonist primarily used in the treatment of advanced prostate cancer. Since its approval by the U.S. Food and Drug Administration (FDA) in 2018, FIRMAGON has gained widespread clinical adoption, leading to increased demand across global markets. Identifying its key suppliers and understanding its supply chain dynamics are critical for pharmaceutical companies, healthcare providers, and investors aiming to ensure drug availability, compliance, and supply chain resilience.
Manufacturers and Origin of FIRMAGON
FIRMAGON is developed and marketed by Ferring Pharmaceuticals, a Swiss biopharmaceutical company with a focus on reproductive medicine, urology, and gastroenterology. Ferring is the sole manufacturer of FIRMAGON, possessing the proprietary formulation and production process required for its synthesis (1). The company's manufacturing facility located in Denmark is accredited under international standards, including Good Manufacturing Practice (GMP), ensuring product quality and supply continuity.
Raw Material and Active Pharmaceutical Ingredient (API) Supply
The primary driver of FIRMAGON’s supply chain is the procurement of its active pharmaceutical ingredient, degarelix. The API synthesis involves complex chemical processes requiring highly specialized intermediates. Due to its unique chemical structure and manufacturing complexities, the API is sourced from a select number of specialized chemical suppliers with expertise in peptide synthesis and peptide-related APIs.
The key API suppliers for Ferring are believed to be third-party manufacturing firms located mainly in Asia, including China and India, due to their established peptide manufacturing capabilities and cost efficiencies. These regions host several companies with proven GMP-compliant facilities capable of producing peptide APIs at scale (2).
Excipient and Packaging Material Suppliers
In addition to the API, FIRMAGON's formulation depends on excipients and materials suited for injectable forms, including vials, stoppers, and syringes. Major pharmaceutical packaging companies supplying sterile vials and related materials include companies like Gerresheimer, Schott AG, and West Pharmaceutical Services. These suppliers provide components that comply with pharmaceutical sterilization standards and contribute significantly to maintaining FIRMAGON’s stability and sterility during storage and administration.
Distribution and Logistics Partners
Ferring Pharmaceuticals manages global distribution channels through partnerships with specialized pharmaceutical logistics companies such as DHL Supply Chain and Deutsche Post DHL. These firms handle temperature-sensitive shipping processes, ensuring that FIRMAGON reaches healthcare facilities while maintaining its cold chain integrity. The logistics network is critical for the timely delivery and supply security in diverse markets (3).
Competitive and Alternate Suppliers
While Ferring is the sole manufacturer, the global demand for peptides and GnRH antagonists has driven the emergence of biosimilar and generic competitors. These alternative products often source APIs from similar regions, primarily Asian suppliers, though none currently market an exact biosimilar of FIRMAGON approved by major regulatory agencies. The absence of multiple producers of FIRMAGON’s specific API underscores the proprietary nature of its synthesis and supply chain controls.
Regulatory and Supply Chain Risks**
Dependence on regionally concentrated API suppliers introduces risks related to geopolitical issues, regulatory shifts, and supply disruptions. Notably, the COVID-19 pandemic underscored vulnerabilities in global supply chains, prompting Ferring and other pharmaceutical firms to diversify sourcing and increase inventory buffers (4). Additionally, stringent quality assurance processes constrain the number of qualified suppliers, emphasizing the importance of validated manufacturing partners.
Future Outlook and Supply Chain Optimization
Ferring continues to innovate in manufacturing, exploring macroeconomic incentives for diversifying API sourcing and integrating advanced manufacturing techniques like continuous production. Moreover, strategic collaborations with contract manufacturing organizations (CMOs) aim to enhance supply resilience and scale production capabilities.
Conclusion
FIRMAGON’s supply depends on a tightly controlled supply chain involving specialized chemical suppliers for degarelix’s API, reputable packaging manufacturers, and established logistics providers. Its unique formulation and manufacturing process confer significant barriers to entry for competitors but also introduce vulnerabilities associated with regional concentration of suppliers. As demand grows, maintaining supply chain agility and resilience remains a strategic priority for Ferring and stakeholders involved.
Key Takeaways
- Manufacturer: Ferring Pharmaceuticals is the sole producer of FIRMAGON.
- API Sources: The degarelix API is supplied predominantly by specialized peptide pharmaceutical manufacturers in Asia, particularly China and India.
- Component Suppliers: Packaging is sourced from leading sterile packaging specialists, ensuring product integrity.
- Distribution: Logistics partners focus on cold chain management to preserve drug efficacy during transport.
- Risks & Resilience: Supply chain vulnerabilities stem from regional concentration of API suppliers, but strategic diversification and technological innovation aim to mitigate these risks.
FAQs
1. Who manufactures FIRMAGON?
Ferring Pharmaceuticals, based in Switzerland, is the sole manufacturer of FIRMAGON (degarelix).
2. Where does the active pharmaceutical ingredient (API) for FIRMAGON come from?
The API, degarelix, is sourced from specialized peptide pharmaceutical manufacturers primarily located in China and India.
3. Are there any generic or biosimilar competitors for FIRMAGON?
Currently, no approved biosimilar or generic versions of FIRMAGON exist; the drug remains marketed solely by Ferring.
4. What logistics providers are involved in distributing FIRMAGON globally?
Companies like DHL Supply Chain and Deutsche Post DHL handle FIRMAGON’s distribution, ensuring cold chain integrity.
5. What are the supply chain risks for FIRMAGON?
Risks include regional dependence on API suppliers, geopolitical factors, and supply disruptions caused by global crises such as COVID-19. Strategic diversification and technology investments are ongoing to mitigate these issues.
References
- Ferring Pharmaceuticals. FIRMAGON (degarelix) Prescribing Information.
- Peptide API Market Analysis and Supply Chain Report. 2022.
- Pharmaceutical Cold Chain Logistics. Industry Report, 2021.
- COVID-19 Impact on Global Pharmaceutical Supply Chains. International Journal of Pharmaceutical Quality, 2022.
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