Suppliers and packagers for prialt

prialt

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060	NDA	TerSera Therapeutics LLC	70720-720-10	1 VIAL, GLASS in 1 CARTON (70720-720-10) / 1 mL in 1 VIAL, GLASS	2018-10-15
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060	NDA	TerSera Therapeutics LLC	70720-722-10	1 VIAL, GLASS in 1 CARTON (70720-722-10) / 5 mL in 1 VIAL, GLASS	2018-10-15
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060	NDA	TerSera Therapeutics LLC	70720-723-10	1 VIAL, GLASS in 1 CARTON (70720-723-10) / 20 mL in 1 VIAL, GLASS	2018-10-15

Suppliers for the Pharmaceutical Drug: PRIALT

Last updated: July 28, 2025

Introduction

PRIALT (ziconotide) is a potent analgesic employed in the treatment of severe chronic pain, especially in cases where opioid therapy proves ineffective or intolerable. Developed by Elan Pharmaceuticals (later acquired by Princeton Pharma Group), ziconotide is a synthetic peptide derived from cone snail venom, offering a sophisticated alternative to traditional analgesics. As an intricate biologic, its manufacturing process is complex, requiring specialized suppliers for its key components and analytical standards. This article examines the landscape of suppliers involved in the production and distribution of PRIALT, offering insights for stakeholders seeking to understand the supply chain, regulatory considerations, and market dynamics.

Overview of Ziconotide and PRIALT

Ziconotide (brand name: PRIALT) is a calcium channel blocker designed for intrathecal administration. Its synthesis involves peptide manufacturing, which demands high precision, peptide synthesis expertise, and stringent quality control. The drug is synthesized as a peptide that mimics a peptide component of cone snail venom, requiring specialized raw materials, including amino acids, peptide synthesis resins, and sophisticated analytical instruments. Given its status as a biologic, the supply chain operates within regulated environments compliant with good manufacturing practice (GMP) standards.

Primary Suppliers of Raw Materials

Amino Acids and Peptide Building Blocks

The manufacturing of ziconotide hinge critically on high-quality amino acids. Major suppliers include:

• Fujifilm Wako Pure Chemical Industries: A leading supplier of pharmaceutical-grade amino acids and peptide synthesis reagents, providing GMP-certified raw materials used in peptide synthesis. Their stringent quality standards ensure purity and consistency necessary for medical peptides [1].

• Thermo Fisher Scientific: Offers a comprehensive catalog of amino acids, peptide synthesis resins, and reagents conforming to pharmaceutical standards that are employed in peptide manufacturing for drugs like ziconotide [2].

• Cambridge Structural Database: Provides specialized peptide frameworks, although direct supply of raw materials like amino acids is through integrated partners.

Peptide Synthesis Resins and Linkers

Resins used in solid-phase peptide synthesis (SPPS) are crucial raw materials supplied by:

• Sigma-Aldrich (Merck): Supplies a broad spectrum of peptide resins, linkers, and supporting chemistries tailored for complex peptide synthesis, compliant with cGMP standards [3].

• SyntheX: A specialized manufacturer of advanced peptide synthesis resins used in high-complexity peptides, including those for pharmaceuticals.

Analytical Standards and Reference Materials

Accurate quality control of ziconotide requires certified reference standards:

• Sigma-Aldrich and USP: Provide pharmaceutical-grade reference standards and analytical standards, essential for quality assurance and regulatory compliance [4].

Active Pharmaceutical Ingredient (API) Manufacturing

Specialized Peptide Synthesis Contract Manufacturers

Manufacturing ziconotide involves complex SPPS, often outsourced to contract manufacturing organizations (CMOs) specializing in biologic peptides:

• Bachem AG: An established CMO with extensive experience in peptide synthesis and GMP manufacturing, Bachem supplies clinical and commercial quantities of peptide APIs, including specialized peptides like ziconotide [5].

• Alpha Synthese: Focused on custom peptide synthesis at GMP standards, capable of producing complex peptides with high purity.

• Polypeptide Laboratories: Provides peptide manufacturing services for high-value peptides, including those used in pharmaceutical products such as PRIALT.

Quality and Regulatory Considerations

Manufacturing is tightly controlled under GMP guidelines enforced by agencies like the FDA and EMA. Suppliers are required to maintain rigorous quality control, process validation, and documentation to ensure batch-to-batch consistency, potency, and safety.

Formulation and Packaging Components

PRIALT's formulation involves sterile, preservative-free solutions for intrathecal infusion:

• Container and Closure Systems: Suppliers like Corning and Schott provide glass and elastomer components meeting pharmaceutical standards for sterile injectables.

• Vial Manufacturing: Companies such as BD (Becton Dickinson) and Gerresheimer supply vials and prefilled syringe systems tailored for sensitive biologic drugs like ziconotide.

Distribution and Logistics Suppliers

Ensuring stability and integrity of PRIALT during distribution relies on specialized logistics providers:

• Cryoport and World Courier are specialized in temperature-sensitive pharmaceutical logistics, critical for maintaining peptide stability during transportation.

• Cold chain management is essential given ziconotide's susceptibility to degradation at higher temperatures.

Market Dynamics and Supplier Strategies

The limited complexity of the active peptide synthesis combined with the specialized nature of PRIALT’s manufacturing means few suppliers operate at the scale required for commercial production. Major pharmaceutical manufacturers, like Eli Lilly and Co. (which acquired Elan), often partner with selected CMO partners with proven GMP compliance to secure supply chain integrity. Due to the peptide's intricate synthesis and strict regulatory environment, vertical integration is common, with companies controlling multiple stages from raw material procurement to API production.

Regulatory and Patent Considerations

The exclusivity of key manufacturing processes and the proprietary nature of ziconotide's synthesis pathway mean that only select suppliers with advanced peptide synthesis capabilities can produce the API. Regulatory agencies require detailed documentation regarding supplier quality systems, process validation, and analytical data as part of the drug approval and post-marketing surveillance.

Future Outlook

Advances in peptide synthesis, automation, and bioprocessing are likely to expand the pool of suppliers capable of producing ziconotide. Contract manufacturers investing in innovative technologies may reduce costs and improve scalability, impacting supply chain resilience. Additionally, biosimilar entrants and alternative sources for peptide raw materials may influence the competitive landscape in the coming years.

Key Takeaways

• Limited Supplier Base: The complex nature of peptide synthesis confines high-quality manufacturing of ziconotide (PRIALT) to specialized, GMP-compliant CMOs and raw material suppliers.
• Strategic Partnerships: Major pharmaceutical companies typically partner with experienced peptide synthesis providers to secure a reliable supply chain.
• Regulatory Compliance: Suppliers must adhere to stringent GMP standards, with comprehensive documentation to meet regulatory requirements.
• Supply Chain Security: Temperature-controlled logistics are vital for maintaining PRIALT's stability throughout distribution.
• Emerging Technologies: Innovations in peptide synthesis and process automation are likely to expand supplier options and reduce manufacturing costs over time.

FAQs

1. Who are the primary suppliers of ziconotide’s raw materials?
Leading suppliers include Fujifilm Wako Pure Chemical Industries and Thermo Fisher Scientific, providing high-purity amino acids and peptide synthesis reagents essential for ziconotide production.

2. Are there multiple manufacturers capable of producing PRIALT at a commercial scale?
Due to the specialized nature of peptide synthesis, a limited number of contract manufacturing organizations, such as Bachem AG and Alpha Synthese, hold the capacity and GMP certifications necessary for commercial production of ziconotide.

3. How critical is the supply chain for PRIALT’s distribution?
Extremely critical; PRIALT requires cold chain logistics to preserve stability. Suppliers of packaging components and temperature-controlled logistics providers are integral to ensuring drug integrity from manufacturing to patient.

4. What regulatory considerations influence supplier selection for PRIALT?
Suppliers must demonstrate compliance with GMP standards, provide detailed process validation data, and deliver consistent batch quality compliant with FDA and EMA regulations.

5. Are there emerging suppliers or technologies that could disrupt the current PRIALT supply chain?
Yes. Advances in peptide synthesis automation, recombinant peptide production, and new cost-effective manufacturing platforms could broaden the supplier base and enhance supply chain resilience in the future.

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Sources

1. Fujifilm Wako Pure Chemical Industries, Product Catalog.
2. Thermo Fisher Scientific, Peptide Synthesis Reagents.
3. Sigma-Aldrich, Peptide Resins and Linkers.
4. United States Pharmacopeia (USP), Analytical Standards.
5. Bachem AG, Peptide Manufacturing Capabilities.