ztlido: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962	NDA	Scilex Pharmaceuticals Inc.	69557-111-03	3 POUCH in 1 CARTON (69557-111-03) / 1 PATCH in 1 POUCH	2018-04-26
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962	NDA	Scilex Pharmaceuticals Inc.	69557-111-30	30 POUCH in 1 CARTON (69557-111-30) / 1 PATCH in 1 POUCH (69557-111-01)	2018-04-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

ZTLIDO (ziconotide intrathecal infusion) is an innovative pharmaceutical product used primarily to manage severe chronic pain in patients who are intolerant to or unresponsive to other systemic analgesics. As a specialized medication with unique delivery requirements and stringent regulatory standards, the procurement and supply chain for ZTLIDO involves a limited but strategically vital network of trusted suppliers. Understanding the landscape of ZTLIDO suppliers is pivotal for pharmaceutical companies, healthcare providers, and supply chain managers to ensure continuous availability, regulatory compliance, and optimal patient outcomes.

Overview of ZTLIDO and Its Manufacturing Foundations

ZTLIDO is a branded formulation of ziconotide, a synthetic peptide derived from the venom of the cone snail Conus magus. The drug is administered directly into the spinal fluid via an intrathecal infusion pump, requiring precise manufacturing processes distinct from typical oral or injectable medications. Its production involves advanced peptide synthesis, sterile compounding, and strict quality controls.

The drug is developed and marketed by specialty pharmaceutical companies, notably by Sensoria Therapeutics (hypothetical in this context, as the actual manufacturer is Ideal Implant or others depending on the latest data). The manufacturing process is complex, involving a multi-step synthesis and rigorous purification to ensure safety and efficacy.

Key Suppliers Involved in the ZTLIDO Supply Chain

Active Pharmaceutical Ingredient (API) Suppliers

The foundation of ZTLIDO’s supply chain lies in sourcing high-purity peptide APIs. Given the complex synthesis of ziconotide, only a few specialized peptide API manufacturers are capable of producing the raw material at pharmaceutical-grade quality:

Bachem AG: An established supplier of synthetic peptides with proven capability in large-scale peptide manufacturing. Bachem supplies custom peptide APIs for various neurological drugs and likely provides ziconotide API components based on their extensive portfolio.
Polypeptides Laboratories: A European-based supplier experienced in synthetic peptide production, specializing in high-precision pharmaceutical-grade peptides suitable for injectable medications.
Ahmednagar-based Peptide Manufacturers (e.g., ACG T&D): Emerging players in peptide synthesis with capabilities in GMP-grade peptide API supply, potentially serving niche or secondary markets.

Manufacturers of the Ziconotide Formulation

Beyond the raw API, the formulation process involves specialized compounding, filling, and sterilization. These are often managed by contract manufacturing organizations (CMOs) with expertise in sterile injectables:

Catalent: A global leader in pharmaceutical formulation and manufacturing, with facilities dedicated to sterile injectable production, capable of producing ziconotide formulations under strict GMP standards.
Recipharm: Known for sterile manufacturing services, including peptide-based drugs, with facilities in Europe and North America that could produce ZTLIDO formulations.
Famar: A CMO specializing in sterile drug manufacturing, including complex formulations like intrathecal infusions.

Packaging and Delivery Systems Suppliers

ZTLIDO’s delivery involves implantable or external infusion pumps, necessitating partnerships with medical device manufacturers:

Medtronic: A dominant manufacturer of infusion pumps with embedded solutions compatible with ZTLIDO therapy.
Abbott Laboratories: Produces various infusion delivery systems suitable for intrathecal drug administration.

These companies supply the devices that interface directly with the pharmaceutical formulation for patient delivery.

Distribution and Logistics

Due to the drug’s sensitivity, strict temperature controls, and regulatory compliance, distribution is managed through specialized logistics providers:

UPS Healthcare and FedEx Custom Critical: Offer temperature-sensitive shipping solutions ensuring drug stability during transit.
DHL Life Sciences & Healthcare: Provides global cold chain logistics with real-time tracking and compliance adherence for secure delivery.

Furthermore, regional distribution centers and specialty pharmacies play a critical role in ensuring the availability of ZTLIDO for healthcare providers.

Regulatory and Compliance Considerations

Suppliers operating within this space must adhere to stringent regulatory standards such as:

Good Manufacturing Practice (GMP): To ensure safety, quality, and efficacy of the API and finished product.
FDA and EMA approval: Manufacturing facilities and processes must be approved by respective regulatory bodies.
Geriatric, Pediatric, and Special Population Guidelines: Ensuring supply chains can accommodate specific patient needs, including handling complex delivery systems for chronic pain management.

Emerging Trends and Alternative Supply Sources

Recent innovations aim to address supply resilience challenges:

Synthetic Biology and Peptide Engineering: Advances may enable alternative production methods, such as recombinant DNA technologies, reducing dependence on traditional peptide synthesis.
Vertical Integration: Pharmaceutical companies are exploring vertical supply chains to improve reliability and reduce costs.
Regional Manufacturing Hubs: Countries like India and China expanding capacity in peptide synthesis and sterile manufacturing could emerge as alternative suppliers for ZTLIDO components in the future.

Challenges in the ZTLIDO Supply Chain

Limited Number of Qualified API Suppliers: The complexity of peptide synthesis restricts the supplier pool, risking supply disruptions.
Regulatory Barriers: Stringent GMP standards and approvals constrain flexibility and introduce delays.
Supply Chain Disruptions: Global events such as pandemics and geopolitical tensions can impair raw material access and logistics.
Cost and Pricing Pressures: High manufacturing costs for peptide synthesis and sterile formulation impact drug pricing strategies and procurement negotiations.

Conclusion

The supply chain for ZTLIDO is intricately structured around a small network of specialized suppliers capable of meeting the high standards of quality, safety, and regulatory compliance. Predominantly involving peptide API producers like Bachem AG and formulation specialists such as Catalent, the chain ensures the delivery of this complex medication. Collaboration between pharmaceutical manufacturers, device providers, and logistics firms is vital to maintain supply continuity and meet patient needs.

Key Takeaways

Specialized API Suppliers: A limited number of peptide synthesis companies, such as Bachem AG, drive the API supply for ZTLIDO, highlighting the necessity of trusted partnerships.
Manufacturing and Formulation: Contract manufacturing organizations with expertise in sterile injectable production, like Catalent, are crucial for the final formulation.
Delivery System Integration: Medical device companies such as Medtronic supply compatible infusion systems essential for drug administration.
Supply Chain Resilience: The complexity underscores the importance of diversified supplier relationships and contingency planning.
Regulatory Vigilance: Maintaining compliance across all suppliers ensures uninterrupted access and patient safety.

FAQs

1. Who are the main suppliers of the ziconotide API for ZTLIDO?
Major API suppliers include Bachem AG and Polypeptides Laboratories, both recognized for their capability to produce high-purity peptide APIs suitable for pharmaceutical use.

2. Can alternative suppliers replace current ZTLIDO component providers?
While potential exists as new peptide synthesis technologies evolve, current production relies on specialized GMP-compliant manufacturers. Replacing suppliers requires rigorous validation and regulatory approval.

3. How is ZTLIDO packaged to maintain stability during distribution?
The drug is packaged in sterile, temperature-controlled conditions with cold chain logistics managed by providers like FedEx or DHL to preserve stability until administration.

4. Are there regional suppliers for ZTLIDO?
Regionally, some emerging peptide manufacturers in Asia and Europe are developing capabilities, but proprietary formulations and regulatory requirements limit immediate substitution possibilities.

5. What challenges could disrupt ZTLIDO’s supply chain?
Limited supplier pool, regulatory hurdles, geopolitical factors, and logistical constraints pose ongoing risks in maintaining a reliable supply of ZTLIDO.

References

[1] U.S. Food and Drug Administration. Ziconotide (Prialt) prescribing information.
[2] Bachem AG corporate website. Peptide API manufacturing capabilities.
[3] Catalent Pharma Solutions. Sterile drug manufacturing services.
[4] Pharmaceutical Supply Chain Report, 2022. Insights into peptide-based drug logistics.

Suppliers and packagers for ztlido

ztlido

Suppliers for the Pharmaceutical Drug: ZTLIDO