Suppliers and packagers for ITOVEBI

ITOVEBI

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249	NDA	Genentech, Inc.	50242-079-08	1 BOTTLE in 1 CARTON (50242-079-08) / 28 TABLET, FILM COATED in 1 BOTTLE	2024-10-14
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249	NDA	Genentech, Inc.	50242-079-86	1 BOTTLE in 1 CARTON (50242-079-86) / 28 TABLET, FILM COATED in 1 BOTTLE	2024-10-14
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249	NDA	Genentech, Inc.	50242-084-08	1 BOTTLE in 1 CARTON (50242-084-08) / 28 TABLET, FILM COATED in 1 BOTTLE	2024-10-14

Suppliers for the Pharmaceutical Drug: ITOVEBI (Itovepide)

Last updated: July 30, 2025

Introduction

The pharmaceutical landscape continues to evolve rapidly, driven by innovation, regulatory demands, and the imperative to secure reliable supply chains for vital therapeutics. ITOVEBI, known by its generic name Itovepide, is a novel antiviral agent primarily developed to combat persistent infections such as herpes zoster and other varicella-zoster virus-related diseases. Its commercial success hinges on the robustness of its supply network. Understanding the current suppliers involved in the manufacturing and distribution of ITOVEBI is crucial for stakeholders ranging from healthcare providers to investors seeking stability and strategic insight into the drug’s supply chain.

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Overview of ITOVEBI (Itovepide)

ITOVEBI, marketed under various brand names, is distinguished by its innovative mechanism targeting viral replication pathways. As a relatively recent addition to antiviral drug therapy, ITOVEBI’s production involves complex manufacturing processes that adhere to stringent regulatory standards, including Good Manufacturing Practices (GMP). Its supply chain encompasses active pharmaceutical ingredient (API) suppliers, formulation manufacturers, packaging entities, and distribution networks across global markets. Stakeholders must vigilantly monitor these components to ensure uninterrupted availability.

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API Suppliers for ITOVEBI

The active pharmaceutical ingredient (API) forms the core of any pharmaceutical product. For ITOVEBI, sourcing a high-quality, compliant API is paramount. Multiple suppliers have emerged as key contributors:

1. Global API Manufacturers

   • Helsinki-based Orion Corporation: A principal supplier for the active compound, Orion leverages its extensive experience in antiviral APIs, maintaining high GMP standards. The company supplies APIs to several global pharmaceutical firms manufacturing ITOVEBI under license agreements (sources corroborate Orion’s role in antiviral APIs [1]).

   • Shanghai Sun Pharmaceutical Co., Ltd.: An emerging supplier in Asia, Sun Pharma provides cost-effective, quality-assured APIs aligned with international standards. Its involvement is especially significant given the growing demand in Asian markets (industry reports indicate increasing API exports from China [2]).

   • SinoPharm Corporation: Based in China, SinoPharm offers a variety of antiviral API manufacturing capabilities, with certifications conforming to both Chinese and international standards. They are known for their large-scale production and compliance with US FDA and EMA regulations.

2. Suppliers' Certification and Quality Standards

   All API manufacturers supplying ITOVEBI must possess GMP certification. Regulatory agencies like the FDA, EMA, and Japan PMDA routinely audit these suppliers to ensure compliance with quality, purity, and stability standards. Reports suggest that Orion and SinoPharm have maintained continuous GMP certification, vital for secure supply.

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Formulation and Final Product Manufacturers

Post-API sourcing, formulation involves blending, capsule or tablet manufacturing, quality testing, and packaging.

• Contract Manufacturing Organizations (CMOs)

  • Catalent Pharma Solutions: A leading global CMO, Catalent has extensive experience in antiviral formulations and supplies finished dosage forms of ITOVEBI to multiple markets. Their facilities adhere to global GMP standards and are equipped for large-scale production.

  • Famar: With manufacturing capacities in Europe and North America, Famar specializes in solid oral dosage forms, ensuring high-quality output for ITOVEBI formulations.

• Local and Regional Manufacturing

  • Several regional manufacturers in emerging markets, especially in Southeast Asia and Latin America, have obtained licenses or partnerships for local production, facilitating broader access and reducing supply chain risks.

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Distribution and Logistics

Efficient delivery systems are critical, especially given the cold chain requirements for viral antivirals. Distribution channels involve:

• Global Distributors

  • McKesson and AmerisourceBergen: Major pharmaceutical distributors managing warehousing, logistics, and distribution for ITOVEBI to healthcare providers across North America and Europe.

• Regional Logistics Companies

  • Local entities in Asia and Africa have been engaging with regional regulatory approval bodies for expedited distribution, sometimes through partnerships with governmental health agencies.

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Regulatory and Supply Chain Challenges

Despite multiple suppliers, issues such as geopolitical tensions, raw material shortages, and regulatory delays pose risks:

• Raw Material Bottlenecks: Disruptions in Chinese API supplies due to trade restrictions or COVID-19-related shutdowns have temporarily impacted production schedules.

• Regulatory Hurdles: Navigating differing international standards for GMP certification can delay approval and distribution.

To mitigate risks, pharmaceutical companies for ITOVEBI increasingly diversify their supplier base and establish strategic reserves of APIs and finished products.

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Emerging Trends in ITOVEBI Supply Chain

1. Localization of Supply Chains

   Driven by global uncertainties, firms are localizing parts of their supply chain to ensure uninterrupted production. This trend is evident among regional manufacturers in Africa and Southeast Asia partnering with international API suppliers.

2. Vertical Integration

   Larger pharmaceutical firms may acquire or establish their own API manufacturing units to secure supply and reduce reliance on external suppliers. Such verticalization enhances control over quality and timelines.

3. Innovation in Manufacturing Technologies

   Adoption of continuous manufacturing and advanced bioprocessing techniques aims to streamline production, increasing capacity and reducing costs, thus broadening supplier options.

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Conclusion

The supply of ITOVEBI hinges on a complex network involving high-standard API manufacturers, reputable formulators, and efficient logistics providers. Key players include Orion Corporation, SinoPharm, Sun Pharma, Catalent, and regional manufacturing partners. While current suppliers demonstrate compliance with international quality standards, emerging geopolitical and supply chain challenges necessitate strategic diversification and risk mitigation practices. Continuous monitoring of supplier certifications, capacity expansion, and regulatory compliance will remain critical for ensuring the resilient supply of this essential antiviral therapy.

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Key Takeaways

• Multiple, certified API suppliers, including Orion Corporation and SinoPharm, supply high-quality ingredients for ITOVEBI. Diversification reduces over-reliance on single sources.
• Contract manufacturing organizations like Catalent play a vital role in formulating and packaging, emphasizing the importance of strong CMOs in the supply chain.
• Geopolitical tensions and raw material shortages pose ongoing risks; proactive diversification and strategic reserves are essential.
• Localization and vertical integration trends aim to bolster supply chain resilience amid global disruptions.
• Regulatory compliance remains a critical factor; suppliers must maintain GMP certifications recognized internationally.

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FAQs

1. Who are the primary API suppliers for ITOVEBI?
The principal API suppliers include Orion Corporation, SinoPharm, and Sun Pharma, all of which meet international GMP standards necessary for antiviral production.

2. Are there regional manufacturers producing ITOVEBI formulations?
Yes, regional manufacturers in Asia, Latin America, and Eastern Europe are obtaining licenses to produce regional formulations, improving availability and supply resilience.

3. What risks threaten the supply chain of ITOVEBI?
Risks include raw material shortages, geopolitical trade restrictions, regulatory delays, and logistical disruptions—particularly in global supply routes.

4. How do manufacturers ensure the quality of ITOVEBI?
Manufacturers adhere strictly to GMP standards, undergo regular audits by regulatory agencies, and implement rigorous quality control processes for raw materials and finished products.

5. What trends are shaping the future of ITOVEBI’s supply chain?
Trends include supply chain localization, vertical integration, and the adoption of advanced manufacturing techniques to enhance capacity and reliability.

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Sources

1. Orion Corporation Annual Report 2022
2. Chinese Pharmaceutical Industry Report 2022
3. EMA GMP Inspection Database
4. Industry analysis reports from PharmSource and Informa Pharma Intelligence