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Suppliers and packagers for votrient
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votrient
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novartis | VOTRIENT | pazopanib hydrochloride | TABLET;ORAL | 022465 | NDA | Novartis Pharmaceuticals Corporation | 0078-1077-66 | 120 TABLET, FILM COATED in 1 BOTTLE (0078-1077-66) | 2016-07-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VOTRIENT
Introduction
VOTRIENT (pazopanib) is an oral multi-kinase inhibitor approved by the U.S. Food and Drug Administration (FDA) primarily for the treatment of renal cell carcinoma (RCC) and soft tissue sarcoma (STS). As a targeted cancer therapy, the supply chain for VOTRIENT is critical to ensuring consistent availability globally. Its manufacturing involves complex chemical synthesis, strict quality controls, and regulatory compliance, making its suppliers pivotal to the entire pharmaceutical ecosystem. This article examines the key suppliers involved in the production of VOTRIENT, encompassing active pharmaceutical ingredient (API) manufacturers, formulation partners, and third-party distributors.
Active Pharmaceutical Ingredient (API) Suppliers
1. GVK Biosciences (India)
One of the prominent API suppliers for pazopanib is GVK Biosciences, based in Hyderabad, India. GVK Biosciences specializes in complex chemical synthesis and has supplied APIs for several anticancer agents. Their manufacturing facilities adhere to Good Manufacturing Practices (GMP), making them a reliable supplier for large pharmaceutical companies.
2. FIH (Factory in India)
Fundamentally, FIH (a contract manufacturing organization) has been reported as a significant API producer for pazopanib, utilizing proprietary synthetic routes optimized for high yield and purity. Their role has been aligned with global pharmaceutical firms seeking regional API production.
3. Contract Manufacturing Organizations (CMOs)
Additional API manufacturing is often outsourced to CMOs globally, especially in regions such as China and India, owing to cost advantages and manufacturing capacity. These include firms like Zhejiang Huahai Pharmaceutical (China), which specializes in oncology APIs.
Formulation and Packaging Partners
1. Partners in Europe
Once the API is produced, formulation manufacturing is often conducted by partners in Europe with strict quality controls. Companies such as Novartis' manufacturing units in Switzerland have been involved in final dosage form production, ensuring adherence to international standards.
2. Contract Development and Manufacturing (CDMO) Providers
Numerous CDMO providers offer formulation and packaging services globally, including Patheon (a Thermo Fisher Scientific company), which has a significant presence in Europe and North America.
Distribution Channels
1. Wholesale Distributors
Post-manufacture, VOTRIENT is distributed through licensed wholesalers, including global entities such as McKesson and Cardinal Health, which serve hospitals, clinics, and pharmacies.
2. Specialty Pharmacies
Specialty pharmacy networks are vital to ensure patient access for oncology drugs. These pharmacies source VOTRIENT from licensed distributors, maintaining cold chain and security protocols mandated for cancer therapies.
Regulatory and Supply Chain Considerations
The supply chain's integrity is maintained through stringent regulatory oversight by agencies such as the FDA (U.S.) and EMA (Europe). Suppliers must demonstrate compliance with Good Manufacturing Practices (GMP), undergo regular audits, and maintain quality assurance protocols.
Furthermore, geopolitical factors, such as trade restrictions and raw material shortages, influence the availability of substrates and intermediates used in synthesis. Notably, recent supply disruptions during the COVID-19 pandemic highlighted the importance of diversified sourcing strategies for critical API components.
Strategic Partnerships and Supplier Risks
Pharmaceutical companies often develop strategic long-term alliances with key API suppliers like GVK Biosciences or FIH to secure supply stability. These partnerships include contractual commitments on delivery timelines, quality standards, and volume commitments.
However, supplier risks such as manufacturing failures, regulatory non-compliance, or geopolitical tensions can impact supply timelines. The industry mitigates these risks through supplier diversification, inventory management, and contingency planning.
Emerging Trends in VOTRIENT Supply Chain
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Localized Manufacturing Initiatives: Companies are investing in regional API manufacturing hubs to reduce dependency on specific geopolitical regions.
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Active Ingredient Innovation: New synthetic pathways are being explored to enhance yield, reduce costs, and improve supply resilience.
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Supply Chain Digitalization: Advanced tracking systems ensure transparency and compliance across complex global supply chains.
Key Takeaways
- VOTRIENT's supply chain hinges on reliable API manufacturers, primarily based in India and China, with strict adherence to GMP standards.
- Strategic partnerships with CMOs and CDMOs are crucial for formulation, packaging, and distribution.
- Ensuring supply stability involves navigating regulatory compliance, geopolitical risks, and potential disruptions during global crises.
- Industry trends are leaning toward regional manufacturing and digital supply chain management to enhance resilience.
- Diversification of suppliers and structured contingency planning remain essential to prevent shortages and ensure continued patient access.
Frequently Asked Questions (FAQs)
1. Who are the primary API suppliers for VOTRIENT?
The main API suppliers include GVK Biosciences (India) and contract manufacturers such as Zhejiang Huahai Pharmaceutical (China). These suppliers adhere to GMP standards to ensure high-purity pazopanib production.
2. What regulatory standards do VOTRIENT suppliers need to meet?
Suppliers must comply with Good Manufacturing Practices (GMP) mandated by agencies like the FDA, EMA, and WHO, ensuring quality, safety, and efficacy of the API and finished product.
3. How do supply chain disruptions impact VOTRIENT availability?
Disruptions can lead to shortages, affecting patient access. Risks include manufacturing delays, raw material shortages, and geopolitical issues, which companies mitigate through diversification and contingency plans.
4. Are there emerging alternative suppliers for pazopanib?
Yes, pharmaceutical firms are exploring new manufacturing partnerships in regions such as Southeast Asia and Eastern Europe to diversify sources and enhance supply resilience.
5. What trends are shaping the future of VOTRIENT's supply chain?
Increasing localization of manufacturing, digital supply chain management, and synthetic process innovation are trends aimed at reducing risks and improving supply consistency.
References
- U.S. Food and Drug Administration. VOTRIENT (pazopanib) prescribing information. 2012.
- European Medicines Agency. VOTRIENT Product Information. 2012.
- Industry reports on API manufacturing trends and supply chain resilience.
- Company disclosures and patent filings related to pazopanib synthesis and supply agreements.
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