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Suppliers and packagers for VARUBI
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VARUBI
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Tersera | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500 | NDA | TerSera Therapeutics LLC | 70720-101-02 | 2 TABLET in 1 BLISTER PACK (70720-101-02) | 2015-10-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Varubi (Rolapitant)
Introduction
Varubi (generic name: rolapitant) is a prescription medication developed to prevent chemotherapy-induced nausea and vomiting (CINV). As an NK1 receptor antagonist, it has become a critical component in antiemetic regimens for cancer patients undergoing highly emetogenic chemotherapy. Securing reliable suppliers for varubi is essential for pharmaceutical companies, healthcare providers, and distributors aiming to ensure consistent drug availability and meet global demands. This report provides a comprehensive overview of the key suppliers for varubi, examining manufacturing capacity, supply chains, regulatory considerations, and emerging market trends.
Manufacturers of Varubi (Rolapitant)
1. Heron Therapeutics, Inc.
Heron Therapeutics is the primary proprietary manufacturer of varubi, having developed and secured FDA approval for the drug in 2015. The company's manufacturing facility in the United States adheres to stringent current Good Manufacturing Practices (cGMP), ensuring high-quality production standards. Heron Therapeutics holds the exclusive rights to commercialize rolapitant in multiple markets, including the US, Canada, and certain other regions. Their capacity expansion initiatives aim to meet increasing global demand, with additional manufacturing facilities under development or consideration.
2. Contract Manufacturing Organizations (CMOs)**
Due to high demand and the necessity for global distribution, Heron Therapeutics collaborates with several CMOs to scale production efficiently:
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Fujifilm Diosynth Biotechnologies
Known for its expertise in complex small-molecule synthesis and cGMP manufacturing, Fujifilm supports Heron’s production capacity, particularly for bulk supply. Their facilities in the UK and the US facilitate high-volume manufacturing of rolapitant intermediates and final formulations. -
Li Shi Pharmaceutical Co., Ltd.
Based in China, Li Shi Pharmaceutical supplies rolapitant active pharmaceutical ingredients (API) for regional markets, conforming to local regulatory standards. Their collaboration expands supply possibilities within Asia, addressing regional and emerging markets. -
Jiangsu Hengrui Medicine Co., Ltd.
Another key CMO in China, Hengrui manufactures APIs and formulations compatible with global standards. Their partnership supports the regional availability of varubi and helps reduce supply chain constraints.
3. Regional Generic and Supply-Chain Diversification
While Heron holds the original patents, some regional markets may see local generic manufacturers or importers sourcing licenced API or formulations. These suppliers often operate under regional licensing agreements, non-exclusive rights or through parallel importation channels.
Supply Chain and Distribution Networks
Global Supply Chain Dynamics
The global supply chain for varubi hinges upon the coordinated efforts of the original manufacturer and regional CMOs to ensure uninterrupted availability. Critical factors include:
- API Production: Secured primarily through CMOs located in China and Europe, with scaling capacity being a focal point due to rising demand.
- Formulation and Packaging: Done predominantly in Heron’s facilities in the US and Europe, adhering to strict cGMP standards.
- Distribution: Global distribution relies on a combination of centralized warehouses and regional distribution partners, enabling support for markets across North America, Europe, Asia, and emerging markets.
Challenges in Supply Chain Stability
- Regulatory Barriers: Varying approval pathways and regulatory requirements can limit the rapid scaling of production or distort supply consistency.
- Manufacturing Bottlenecks: Complex synthesis pathways for rolapitant, a relatively new molecule, mean manufacturing capacity expansion requires significant time and investment.
- Global Trade Dynamics: Tariffs, export restrictions, and geopolitical tensions impact the flow of APIs and finished goods, especially from China and Europe.
Regulatory Landscape and its Impact on Suppliers
Securing approval in different jurisdictions influences supplier accreditation and production. Heron Therapeutics holds approvals from agencies such as FDA (US), EMA (Europe), Health Canada, and others, each necessitating compliance with distinct quality standards.
Regional licensing agreements with local manufacturers smooth the pathway for regional markets but also introduce supplier variability and logistical challenges.
Emerging Trends and Market Dynamics
1. Regional Expansion of Suppliers
In response to global demand, there is a trend towards regional manufacturing hubs in Asia, Europe, and South America. These facilities help mitigate supply risks due to geopolitical or trade disruptions.
2. Increased Focus on API Security
Given the complexity, many pharmaceutical companies now prioritize securing reliable API suppliers in order to minimize shortages or delays.
3. Strategic Partnerships and Licensing Agreements
Heron Therapeutics has been expanding licensing with regional partners to accelerate varubi's availability, expected to influence future supply chain structures.
4. Potential for Biosimilar and Generic Entry
While rolapitant's patent protection limits generic competition temporarily, patent expiry and regional patent challenges may open avenues for alternative suppliers in the future.
Conclusion
The supply landscape for varubi (rolapitant) is centered around Heron Therapeutics’ manufacturing capabilities supported by global CMOs, particularly in China, Europe, and North America. The supply chain's stability depends on scalable API production, regulatory compliance, and strategic regional partnerships. As demand grows, supply diversification and regional manufacturing expansion become critical. Future developments are likely to focus on enhancing supply resilience, securing API sources, and entering new markets through licensing agreements.
Key Takeaways
- Primary Manufacturer: Heron Therapeutics is the exclusive innovator and primary supplier of varubi, leveraging collaborations with global CMOs for manufacturing scale-up.
- API Suppliers: Leading API producers include Chinese firms like Li Shi Pharmaceutical and Jiangsu Hengrui, offering regional supply solutions aligned with local regulatory standards.
- Supply Chain Challenges: Manufacturing complexity, regulatory requirements, and geopolitical factors influence supply stability; diversification and regional hubs are strategic mitigations.
- Market Expansion: Licensing agreements, regional manufacturing hubs, and potential biosimilar entries will shape the evolving supply landscape.
- Business Implication: Pharmaceutical companies should monitor API supplier reliability, regulatory developments, and geopolitical trends to ensure consistent access to varubi.
FAQs
Q1. Who is the primary manufacturer of varubi (rolapitant)?
Heron Therapeutics, Inc. is the exclusive developer and proprietary manufacturer of varubi, overseeing global production and distribution.
Q2. Are there regional suppliers for varubi API?
Yes. Key API suppliers include Chinese companies like Li Shi Pharmaceutical and Jiangsu Hengrui Medicine, supporting regional markets and diversifying supply sources.
Q3. What are the main challenges facing varubi supply chains?
Challenges include complex manufacturing processes, regulatory hurdles, API sourcing limitations, geopolitical tensions, and trade restrictions impacting global logistics.
Q4. Are biosimilar or generic versions of varubi available?
Currently, no biosimilar or generic versions are available due to patent protections. Future patent expirations may alter this landscape.
Q5. How is market demand influencing supplier strategies?
Rising demand prompts Heron and partners to expand manufacturing capacity, establish regional hubs, and forge new licensing agreements to meet global needs efficiently.
Sources
[1] Heron Therapeutics. (2022). Varubi (rolapitant) prescribing information.
[2] U.S. Food and Drug Administration (FDA). (2015). Approval documentation for Varubi.
[3] Heron Therapeutics Investor Relations. (2023). Company updates on manufacturing and licensing.
[4] Industry Reports on API manufacturing in China and Europe.
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