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Suppliers and packagers for generic pharmaceutical drug: DEGARELIX ACETATE
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DEGARELIX ACETATE
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: Degarelix Acetate
Introduction
Degarelix acetate is a gonadotropin-releasing hormone (GnRH) antagonist primarily used in the management of prostate cancer. As a peptide-based therapeutic, it commands a specialized supply chain involving high-quality raw materials, synthesis expertise, and compliant manufacturing. This article examines key suppliers involved in the production of degarelix acetate, addressing raw material sourcing, active pharmaceutical ingredient (API) manufacturing, and formulation components. It serves as a comprehensive resource for stakeholders seeking to understand the global supply landscape for this critical drug.
Overview of Degarelix Acetate Supply Chain
Degarelix acetate production involves multiple stages, from peptide synthesis to formulation. The supply chain complexity necessitates collaboration among raw material suppliers, active pharmaceutical ingredient (API) manufacturers, and finished drug product (FDP) manufacturers. Ensuring supply stability hinges on sourcing high-quality raw materials, robust manufacturing capabilities, and compliance with regulatory standards.
Raw Material Suppliers
The foundational phase of degarelix acetate production relies heavily on the procurement of high-purity amino acids and peptide synthesis reagents. These materials are essential for the solid-phase peptide synthesis (SPPS) process used to produce the active peptide.
Amino Acids and Peptide Reagents
Leading suppliers of pharmaceutical-grade amino acids include:
- Cambridge Synthesis (UK): Provides custom peptide synthesis reagents and amino acids conforming to pharmacopeial standards.
- Sino Biologic (China): Supplies high-quality amino acids, peptides, and synthesis reagents suitable for clinical and commercial production.
- Iris Biotech (Germany): Specializes in a comprehensive range of amino acids and building blocks for peptide synthesis.
These suppliers meet stringent pharmaceutical purity requirements, including GMP compliance, which is essential for API production.
Peptide Synthesis Equipment and Reagents
- Milestone Discovery: Offers peptide synthesis machinery compatible with large-scale manufacturing, including solid-phase synthesizers.
- CEM Corporation (USA): Produces peptide synthesizers and reagents tailored for complex peptide manufacturing.
Active Pharmaceutical Ingredient (API) Manufacturers
Securing reliable and compliant API manufacturers is critical. The complexity of degarelix’s peptide nature and manufacturing demands strict quality control.
Key API Suppliers
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Ferring Pharmaceuticals (Sweden): The originator of degarelix, Ferring is a primary API supplier with a vertically integrated supply chain encompassing peptide synthesis, purification, and formulation. Ferring holds extensive manufacturing capacity within Europe, ensuring quality and supply stability.
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Bachem (Switzerland): A renowned peptide producer with extensive experience in manufacturing APIs for oncology therapies. Bachem offers GMP-produced peptides suitable for both clinical trials and commercial use.
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Samsung Biologics (South Korea): Has entered the peptide API space, expanding manufacturing capacity and offering competitive production options.
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Siegfried AG (Switzerland): Provides peptide synthesis services and finished API manufacturing, with emphasis on high purity and compliance.
Contract Manufacturing Organizations (CMOs)
Given the complexity of peptide synthesis, many pharmaceutical companies partner with CMOs specializing in peptide API production:
- Catalent (USA): Offers peptide synthesis and API manufacturing services with GMP compliance.
- Lonza (Switzerland): Provides custom peptide manufacturing solutions with extensive regulatory experience.
Formulation and Packaging Suppliers
Once the API is synthesized, it requires formulation into injectable forms and packaging for distribution:
- Boehringer Ingelheim (Germany): Supplies sterile fill-finish services tailored for peptides like degarelix acetate.
- Qualicaps (USA): Provides capsule and vial packaging solutions adhering to pharmaceutical standards.
- SGS (Switzerland): Offers stability testing and packaging validation services for peptide products.
Regional Supply Dynamics
The global supply chain for degarelix acetate features dominant players primarily in Europe, North America, and Asia.
- Europe: Manufacturers like Ferring, Bachem, and Siegfried are central due to robust GMP infrastructure and regulatory frameworks.
- North America: Contract manufacturers such as Catalent and Lonza supply the U.S. and Canadian markets.
- Asia: Countries like South Korea and China have vertically integrated peptide manufacturing capabilities, expanding the supply options and reducing costs.
Regulatory and Quality Considerations
Suppliers must adhere to regulatory standards such as those mandated by the FDA, EMA, and ICH guidelines. GMP compliance ensures that raw materials, APIs, and finished products meet international quality benchmarks. For companies importing or exporting degarelix acetate, supplier validation and batch consistency are paramount for regulatory approval.
Emerging Trends and Future Supply Opportunities
- Vertical Integration: Originators like Ferring continue to develop integrated manufacturing setups, reducing dependency on third-party suppliers.
- Supply Chain Diversification: The growing demand for degarelix acetate has prompted companies to explore new regional manufacturing hubs, notably in Asia-Pacific.
- Biotechnological Advances: Synthetic peptide manufacturing is benefiting from innovations such as continuous manufacturing processes, potentially enhancing supply robustness.
Conclusion
The supply chain for degarelix acetate is characterized by sophisticated, high-quality sourcing strategies worldwide. Leading manufacturers such as Ferring Pharmaceuticals and Bachem dominate the API production landscape, supported by globally dispersed raw material suppliers and contract manufacturing partners. Maintaining a resilient, compliant supply chain necessitates ongoing collaboration among these stakeholders, coupled with adherence to evolving regulatory standards. As demand increases, diversification of manufacturing sources and technological advancements are poised to enhance supply stability and cost-efficiency.
Key Takeaways
- Primary API Suppliers: Ferring Pharmaceuticals, Bachem, Samsung Biologics, Siegfried AG.
- Raw Material Procurement: Sourced from specialized amino acid and peptide reagent suppliers like Cambridge Synthesis and Iris Biotech.
- Manufacturing Expertise: Critical to engage GMP-compliant providers, especially for complex peptide synthesis.
- Regional Dynamics: Europe and North America remain central, but Asian manufacturers are expanding their presence.
- Regulatory Compliance: Ensuring supplier adherence to GMP and other standards is essential for product quality and market access.
FAQs
1. Who are the leading suppliers of degarelix acetate active pharmaceutical ingredients?
Ferring Pharmaceuticals and Bachem are the predominant suppliers of GMP-grade degarelix API. They possess extensive manufacturing capabilities, regulatory approvals, and experience in peptide synthesis.
2. What raw materials are most critical in the production of degarelix acetate?
High-purity amino acids, peptide coupling reagents, and solid-phase synthesis support materials are essential for peptide chain assembly.
3. Can third-party CMOs reliably produce degarelix acetate?
Yes, several reputable CMOs like Catalent and Lonza possess the capabilities to synthesize and purify degarelix API, ensuring quality and regulatory compliance.
4. How do regional differences impact degarelix acetate supply?
European manufacturers dominate due to stringent regulatory environments and established infrastructure, but Asian suppliers are increasing capacity through technological advancements, fostering global supply diversification.
5. What future trends could influence the supply chain of degarelix acetate?
Emerging trends include increased vertical integration, technological innovation in peptide manufacturing, and regional expansion of manufacturing facilities, all aimed at improving supply resilience and cost-efficiency.
References
- Ferring Pharmaceuticals. (2022). Degarelix Product Information.
- Bachem AG. (2022). Peptide Manufacturing Capabilities.
- Siegfried AG. (2021). Peptide APIs and Contract Manufacturing.
- Sino Biologic. (2022). Raw Material Supplies for Peptide Synthesis.
- [Regulatory Guidelines for Peptide APIs. ICH Q7, EMA, FDA.]
Note: All data points are based on publicly available sources and industry insights up to early 2023.
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