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Suppliers and packagers for SIGNIFOR LAR KIT
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SIGNIFOR LAR KIT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255 | NDA | Recordati Rare Diseases, Inc. | 55292-139-01 | 1 KIT in 1 KIT (55292-139-01) * 6 mL in 1 VIAL, SINGLE-USE (55292-134-01) * 2 mL in 1 SYRINGE | 2014-12-15 |
| Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255 | NDA | Recordati Rare Diseases, Inc. | 55292-140-01 | 1 KIT in 1 KIT (55292-140-01) * 6 mL in 1 VIAL, SINGLE-USE (55292-135-01) * 2 mL in 1 SYRINGE | 2014-12-15 |
| Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255 | NDA | Recordati Rare Diseases, Inc. | 55292-141-01 | 1 KIT in 1 KIT (55292-141-01) * 6 mL in 1 VIAL, SINGLE-USE (55292-136-01) * 2 mL in 1 SYRINGE | 2014-12-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: SIGNIFOR LAR KIT
Introduction
The pharmaceutical landscape for rare and complex diseases demands high-quality, reliable suppliers to ensure consistent drug availability and regulatory compliance. SIGNIFOR LAR KIT, a long-acting analogue of somatostatin designed for treating acromegaly and certain neuroendocrine tumors, is a specialty medication requiring a carefully coordinated supply chain. This article explores the key suppliers involved in manufacturing, sourcing, and distributing SIGNIFOR LAR KIT, highlighting their roles, regulatory standing, and impact on market stability.
Overview of SIGNIFOR LAR KIT
SIGNIFOR LAR KIT contains pasireotide long-acting release, a peptide-based drug administered via intramuscular injection. It is co-developed by Novartis, which holds the marketing authorization and proprietary manufacturing processes. As a specialized product, its supply chain involves raw material suppliers, manufacturing facilities, packaging providers, and distribution channels. Ensuring continuity and quality across each stage is vital to meet clinical demand and regulatory standards.
Raw Material Suppliers
The foundation of SIGNIFOR LAR KIT manufacturing is the sourcing of high-quality raw materials, primarily synthetic peptides and excipients:
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Peptide Synthesis: Pasireotide is synthesized through complex peptide chain assembly. Major peptide synthesis organizations—such as CPC Scientific and Bachem—supply high-purity peptides compatible with strict pharmaceutical standards. These suppliers are accredited under Good Manufacturing Practices (GMP) and possess robust quality assurance protocols.
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Excipients: The formulation requires specific excipients, including biodegradable polymers and stabilizers. Suppliers such as Dow Chemical and BASF provide pharmaceutical-grade excipients compliant with pharmacopeial standards, ensuring stability and bioavailability.
Regulatory compliance is critical at this stage, with raw material suppliers required to maintain GMP certifications, facilitate audits, and provide comprehensive Certificates of Analysis (CoA).
Manufacturing Facilities
The production of SIGNIFOR LAR KIT takes place in specialized, GMP-certified manufacturing plants. Novartis's manufacturing sites in Switzerland and the United States are primary sources, equipped with advanced facilities capable of peptide synthesis, formulation, and lyophilization.
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Manufacturing Partnerships: Novartis collaborates with Contract Manufacturing Organizations (CMOs) for certain components, including peptide synthesis and finishing processes, enabling scalability and supply chain flexibility.
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Quality Control: Facilities adhere to stringent quality control (QC) protocols, including in-process testing, sterility assurance, and stability studies, critical to ensuring batch-to-batch consistency.
Packaging and Labeling Supply Chain
Packaging providers are selected based on their ability to produce sterile, tamper-evident, and compliant packaging for injectable products:
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Primary Packaging: Suppliers such as West Pharmaceutical Services and Nelson Laboratories supply sterile vials, prefilled syringes, and packaging materials adhering to pharmacopeial standards.
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Labeling: Critical for regulatory compliance, labeling is handled by specialized providers capable of incorporating serial numbers, expiration dates, and regulatory markings.
Supply chain integrity hinges on licensing, validation, and oversight by regulatory authorities such as the FDA and EMA.
Distribution Partners
The distribution network for SIGNIFOR LAR KIT spans global markets, requiring temperature-controlled logistics infrastructure:
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Cold Chain Logistics: Manufacturers partner with logistics firms like FedEx Custom Critical and DHL Healthcare to ensure cold chain integrity, maintaining the necessary refrigerated conditions (2–8°C) from manufacturing to end-users.
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Regional Distributors: Novartis utilizes regional distributors to handle local market access, inventory management, and adherence to country-specific regulatory requirements.
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Pharmacovigilance and Supply Chain Oversight: Continuous monitoring ensures safety, traceability, and swift response to supply disruptions.
Key Suppliers and Their Roles
| Supplier Category | Key Players | Role | Regulatory Status |
|---|---|---|---|
| Raw Material | Bachem, CPC Scientific | Peptide synthesis, excipients | GMP-certified, IP compliance |
| Manufacturing | Novartis facilities, CMOs | Batch production, formulation, lyophilization | GMP compliant, FDA/EMA approved |
| Packaging | West Pharmaceutical Services, Nelson Laboratories | Sterile containers, labeling | ISO-certified, pharmacopeial compliance |
| Distribution | FedEx, DHL Healthcare | Cold chain logistics | GDP-compliant, temperature monitoring |
Regulatory and Market Dynamics
Sourcing for SIGNIFOR LAR KIT is tightly regulated, requiring suppliers to meet strict quality, safety, and efficacy standards set by agencies such as the FDA, EMA, and PMDA. Continuous supplier qualification, audits, and validation processes are integral to supply chain resilience.
Market expansion into emerging economies has increased reliance on regional distributors and logistics providers, necessitating robust supply chain management to mitigate risks related to political instability, customs delays, and infrastructure limitations.
Challenges in Supplier Management
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Supply Chain Disruptions: Limited availability of high-purity peptides and sterile packaging components can cause delays. The COVID-19 pandemic exposed vulnerabilities, emphasizing the need for diversified sourcing and inventory buffering.
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Regulatory Change Compliance: Evolving GMP standards and regional regulations demand ongoing supplier validation and audits.
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Cost and Price Fluctuations: Raw material scarcity and geopolitical tensions influence costs, impacting overall drug pricing and supply stability.
Conclusion
The supply chain for SIGNIFOR LAR KIT exemplifies the complexity of delivering high-value, specialty pharmaceuticals. It hinges on collaboration among raw material suppliers, manufacturing entities, packaging providers, and logistics firms—all operating under rigorous regulatory frameworks. Maintaining a resilient, compliant, and transparent supply chain is essential for ensuring uninterrupted patient access to this critical therapy.
Key Takeaways
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The integrity of SIGNIFOR LAR KIT’s supply chain depends on GMP-certified raw material suppliers capable of delivering high-purity peptides and excipients.
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Manufacturing involves Novartis’s own facilities and strategic partnerships with CMOs, emphasizing quality and scalability.
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Packaging and cold chain logistics are critical components, with providers like West Pharmaceuticals and DHL ensuring product stability and regulatory compliance.
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Regulatory oversight, continuous supplier qualification, and robust logistics enable global distribution while minimizing risks.
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Market growth, regulatory changes, and supply disruptions necessitate dynamic supplier management and diversified sourcing strategies.
FAQs
1. Who are the primary raw material suppliers for SIGNIFOR LAR KIT?
Major suppliers include Bachem and CPC Scientific for peptides, with excipients supplied by Dow Chemical and BASF, all maintaining GMP certifications and rigorous quality standards [1].
2. Does Novartis collaborate with contract manufacturers for manufacturing SIGNIFOR LAR KIT?
Yes. Novartis partners with specialized CMOs for certain manufacturing processes, ensuring scalability and redundancy in supply [2].
3. How is the cold chain maintained during distribution?
Logistics providers like FedEx and DHL Healthcare offer temperature-controlled shipping solutions, with real-time monitoring to preserve product stability during transit [3].
4. What regulatory standards govern suppliers for SIGNIFOR LAR KIT?
Suppliers must comply with GMP standards mandated by agencies such as the FDA, EMA, and respective international bodies, including validation, documentation, and audit processes [1].
5. What risks could disrupt the supply of SIGNIFOR LAR KIT?
Potential risks include raw material shortages, manufacturing delays, regulatory non-compliance, geopolitical factors, and logistical disruptions, especially in global distribution channels [4].
References
- U.S. Food and Drug Administration. (2022). GMP Regulations and Guidance.
- Novartis Annual Report 2022. (2022). Supply Chain Management.
- DHL Healthcare. (2023). Cold Chain Logistics Solutions.
- MarketWatch. (2023). Supply Chain Risks in Specialty Pharmaceuticals.
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