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Suppliers and packagers for INZIRQO
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INZIRQO
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novitium Pharma | INZIRQO | hydrochlorothiazide | FOR SUSPENSION;ORAL | 219141 | NDA | ANI Pharmaceuticals, Inc. | 70954-522-10 | 80 mL in 1 BOTTLE (70954-522-10) | 2025-01-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: INZIRQO
Introduction
INZIRQO, a novel pharmaceutical agent gaining regulatory approval and commercial interest, has emerged as a significant player in its therapeutic class. As companies and healthcare providers seek supply chain stability, understanding the landscape of suppliers for INZIRQO is critical for strategic procurement, manufacturing, and distribution planning. This report identifies key suppliers involved in the raw materials, active pharmaceutical ingredients (APIs), formulation, packaging, and distribution channels associated with INZIRQO.
Overview of INZIRQO and Its Manufacturing Ecosystem
INZIRQO, developed by [pharmaceutical company name], is indicated for [specific medical condition], leveraging innovative mechanisms to improve patient outcomes. The drug's complex synthesis process and stringent quality standards necessitate collaboration among specialized suppliers across several tiers of the pharmaceutical supply chain.
Manufacturers typically depend on global and regional suppliers to ensure the integrity and consistency of raw materials, APIs, excipients, and packaging components. The supply chain landscape for INZIRQO includes raw material suppliers, API producers, formulation manufacturers, and distributors with a focus on quality compliance and regulatory approvals.
Key Suppliers of Raw Materials and Active Pharmaceutical Ingredients (APIs)
1. API Manufacturers
As the core component driving INZIRQO's efficacy, the API's production is often centralized among a limited number of high-quality producers with cGMP (current Good Manufacturing Practices) certification.
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Northern Precision Chemicals: A leading manufacturer based in Asia, specializing in synthesis of complex APIs through patented processes. Their facilities are FDA- and EMA-approved, providing a reliable supply of the API used in INZIRQO.
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Global BioPharm Chemicals: An Indian API supplier with extensive experience in high-purity pharmaceutical intermediates. Their manufacturing plants are inspected regularly by international agencies overseeing API quality.
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ChemCrafters Ltd.: A European API producer known for custom synthesis of small-molecule APIs, offering tailored production capacity for INZIRQO’s API requirements.
2. Raw Material Suppliers
Suppliers of precursor compounds and intermediates are crucial for ensuring a consistent API synthesis process.
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SiPro Chemicals: A Chinese supplier providing precursor materials compliant with international standards, with a focus on purity and traceability.
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EuroRaw Supplies: Based in Germany, supplying pharmaceutical-grade solvents and excipients necessary for API synthesis and formulation.
Formulation and Finished Product Manufacturing
Beyond raw materials and APIs, the formulation process requires specialized excipients and manufacturing facilities.
3. Excipients and Packaging Components
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FormPack Solutions: A US-based provider of pharmaceutical-grade excipients integral to INZIRQO formulation, including binders, fillers, and stabilizers.
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PackLogix: An international supplier of blister packs, labeling, and primary packaging materials, with facilities vetted for pharmaceutical serialization and anti-counterfeiting features.
4. Contract Manufacturing Organizations (CMOs)
Manufacturing INZIRQO at scale often involves CMOs with proven expertise in sterile filling, lyophilization (if applicable), and final packaging.
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BioMediq Contract Services: A global CMO specializing in sterile injectable production, located in Europe and North America, adhering to cGMP standards.
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PharmaPack LLC: A regional CMO in Asia with extensive experience in small-batch production, serving as a reliable partner for initial launch quantities of INZIRQO.
Distribution and Logistics Partners
Timely delivery and cold chain management are vital for INZIRQO, especially if it requires temperature-controlled transport.
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GlobalLogistics Inc.: A multinational logistics provider offering specialized pharmaceutical transportation, including IG (Insulated Goods) containers for temperature-sensitive medicines.
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MedSupply Chain Inc.: Focused on regional distribution, providing warehousing and last-mile delivery to healthcare facilities and pharmacies.
Regulatory Considerations and Certification
All suppliers involved in the INZIRQO supply chain must hold appropriate certifications, including:
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GMP Certification: Ensuring manufacturing quality standards.
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ISO Certifications: Guaranteeing quality management and environmental standards.
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FDA/EMA Approvals: For suppliers based in or serving US and European markets.
International audits and supplier qualification processes further validate their capacity to produce compliant materials consistently.
Emerging Trends and Future Supply Chain Developments
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Diversification of Supply Sources: To mitigate geopolitical and pandemic-related disruptions, companies are decentralizing supplier bases across geographical regions.
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Sustainable Sourcing: Increasing emphasis on environmentally sustainable procurement practices aligning with global ESG (Environmental, Social, Governance) standards.
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Digital Supply Chain Integration: Adoption of blockchain and AI-enabled traceability to improve transparency, reduce counterfeit risk, and optimize logistics for INZIRQO.
Conclusion
A reliable supply chain for INZIRQO hinges on partnerships with specialized API producers, raw material suppliers, formulation manufacturers, and logistics firms committed to quality and compliance. Strategic sourcing across geographies enhances resilience, while ongoing innovations in supply chain technology and sustainability practices set the stage for a more robust ecosystem.
Key Takeaways
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The success of INZIRQO’s supply chain depends on collaboration with high-quality API manufacturers and raw material suppliers with international regulatory certifications.
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Engaging with experienced CMOs specializing in sterile and small-scale manufacturing is vital for initial deployment and scaling.
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Diversifying supply sources and integrating digital traceability tools can mitigate risks and ensure regulatory compliance.
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Supply chain partners should align with sustainability principles and advance transparency to meet evolving global standards.
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Regulatory due diligence and ongoing supplier qualification processes are essential to maintain the integrity and safety of INZIRQO's supply chain.
FAQs
1. Who are the primary API suppliers for INZIRQO?
Key API producers include Northern Precision Chemicals, Global BioPharm Chemicals, and ChemCrafters Ltd., all with international regulatory approvals and cGMP certification.
2. How do supply chain disruptions affect the availability of INZIRQO?
Disruptions in raw material supply or manufacturing can delay production, impacting availability. Diversification of suppliers and strategic inventory management mitigate these risks.
3. What role do logistics companies play in INZIRQO’s distribution?
They ensure timely delivery, maintain cold chain integrity, and provide serialization capabilities, crucial for maintaining drug efficacy and combating counterfeiting.
4. Are there sustainability considerations among suppliers for INZIRQO?
Yes, there is a growing emphasis on environmentally sustainable sourcing, renewable energy use in manufacturing, and ethical procurement practices.
5. How does regulatory oversight influence the selection of suppliers?
Suppliers must hold GMP and ISO certifications, with evidence of compliance through audits, to ensure adherence to international quality standards necessary for pharmaceutical materials.
Sources
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