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Suppliers and packagers for generic pharmaceutical drug: vonoprazan fumarate
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vonoprazan fumarate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Phathom | VOQUEZNA | vonoprazan fumarate | TABLET;ORAL | 215151 | NDA | Phathom Pharmaceuticals Inc. | 81520-100-30 | 30 TABLET in 1 BOTTLE, PLASTIC (81520-100-30) | 2023-11-10 |
| Phathom | VOQUEZNA | vonoprazan fumarate | TABLET;ORAL | 215151 | NDA | Phathom Pharmaceuticals Inc. | 81520-200-30 | 30 TABLET in 1 BOTTLE, PLASTIC (81520-200-30) | 2023-11-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Vonoprazan Fumarate
Introduction
Vonoprazan fumarate, a potent potassium-competitive acid blocker (P-CAB), has gained significant attention within the pharmaceutical industry for its therapeutic efficacy in treating gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, and Helicobacter pylori infections. Since its approval, the drug’s manufacturing and supply chain have become critical to meet global demand. This article examines key suppliers involved in the production of vonoprazan fumarate, analyzing their roles, capacity, and market influence within the pharmaceutical supply ecosystem.
Overview of Vonoprazan Fumarate
Marketed initially by Takeda Pharmaceutical Company, vonoprazan fumarate represents a novel class of acid suppressants with a distinct mechanism of action beyond traditional proton pump inhibitors (PPIs). Its high potency, rapid onset, and longer duration of acid suppression have fueled interest from generic manufacturers and contract manufacturing organizations (CMOs). Ensuring a reliable supply chain involves complex sourcing of raw materials, intermediates, and final formulations, with multiple suppliers contributing at various stages.
Raw Material and Intermediate Suppliers
The production of vonoprazan fumarate relies heavily on high-quality chemical intermediates and active pharmaceutical ingredients (APIs). Suppliers of these raw materials significantly influence global availability.
1. Takeda Pharmaceutical Company
As the original patent holder, Takeda maintains control over the supply chain for the licensed version, including proprietary synthesis processes and initial raw material sourcing. They also engage in strategic partnerships for manufacturing and distribution, particularly in Asia. Takeda’s proprietary networks ensure reliable supply but may limit access for other entities seeking licensed or generic versions.
2. Chinese Chemical Manufacturers
Numerous Chinese chemical companies have emerged as major suppliers of intermediates for vonoprazan fumarate. These firms leverage cost-effective manufacturing and have scaled up production to meet increasing global demand.
- Shandong Altair Industrial Co., Ltd.
- Zhejiang Hisun Pharmaceutical Co., Ltd.
- Shanghai ChemPartner Co., Ltd.
These manufacturers produce key chemical intermediates, such as substituted pyrimidines and related scaffolds, essential in the synthesis pathway of vonoprazan. Their capacity expansion aligns with increased demand, but quality assurance and regulatory compliance remain vital considerations.
3. Indian API Manufacturers
India’s pharmaceutical sector has also entered as a supplier hub for intermediates and APIs relevant to vonoprazan production.
- Sun Pharmaceutical Industries Ltd.
- Aurobindo Pharma Limited
- Glenmark Pharmaceuticals
These companies focus on large-volume API synthesis, often facilitating the production of generic versions post-patent expiry, with quality standards adhering to WHO and USFDA guidelines.
Contract Manufacturing Organizations (CMOs)**
Growing reliance on CMOs has enabled pharmaceutical firms to outsource manufacturing processes, especially for complex chemical synthesis like vonoprazan.
- WuXi AppTec (China): A prominent CMO with capabilities in API synthesis, process development, and scale-up, WuXi has established facilities tailored to high-potency compounds.
- Boehringer Ingelheim (Germany): Known for complex chemical manufacturing, they offer expertise in the synthesis of intermediates.
- Lonza (Switzerland): Provides multi-step synthesis services, including formulation and manufacturing at commercial scale.
These organizations ensure quality control, regulatory compliance, and scalability, critical for minimizing supply disruptions.
Key Market Players and Licensing
Although Takeda remains the primary patent holder, licensing agreements have led to several generic manufacturers entering the market, especially following patent expiration in certain regions. These companies often source APIs and intermediates from Chinese and Indian suppliers, emphasizing the importance of a reliable supply network.
Generic Manufacturers:
- Alvogen
- Zheijiang Jinhua Pharmaceutical Co., Ltd.
- Cipla Ltd.
They rely on imported raw materials or APIs from their supplier networks, with some establishing their own manufacturing units to control quality and costs.
Regulatory and Supply Chain Challenges
The intricate supply network for vonoprazan fumarate faces challenges, including:
- Regulatory compliance: Ensuring raw materials meet cGMP standards amid diverse supplier origins.
- Quality assurance: Variability in supplier quality necessitates rigorous testing and validation.
- Supply disruptions: Geopolitical issues, manufacturing delays, or raw material shortages can impact global availability.
- Intellectual property rights: Navigating patent landscapes influences sourcing and licensing.
Producers and purchasers must perform diligent due diligence, including supplier audits and continuous monitoring to mitigate risks.
Supply Chain Trends and Future Outlook
The supply landscape for vonoprazan fumarate is evolving with increased global demand. Trends include:
- Localization of manufacturing: Regulatory pressures encourage regional production hubs, reducing dependency on geographically concentrated supply chains.
- Vertical integration: Large pharmaceutical firms may acquire or establish production units for key intermediates, reducing reliance on external suppliers.
- Enhanced quality standards: The emphasis on cGMP and ISO compliance is driving higher supplier qualification standards.
- Potential for biosynthesis: Innovations in biotechnological synthesis avenues may alter future supplier dynamics.
Conclusion
The supply chain for vonoprazan fumarate is characterized by a diverse network involving original developers, Chinese chemical producers, Indian API manufacturers, and global CMOs. Ensuring supply reliability depends on strategic supplier relationships, quality assurance, and proactive management of geopolitical and regulatory risks. As the market expands, diversification and vertical integration will likely become more prominent to meet burgeoning demand efficiently.
Key Takeaways
- Global supply chain complexity necessitates vigilant quality control and regulatory compliance across all suppliers.
- Chinese suppliers dominate intermediates’ manufacturing, but European and Indian firms are vital for high-quality APIs and complex synthesis.
- CMOs play a critical role in scaling production while maintaining standards, especially for complex compounds like vonoprazan.
- Patent expiration and licensing influence the entry of generics, impacting sourcing dynamics.
- Future trends indicate increased localization and integration to improve resilience and reduce supply risks.
FAQs
1. Who are the primary suppliers of vonoprazan fumarate?
Major suppliers include Takeda (original patent holder), Chinese chemical companies (for intermediates), Indian API manufacturers, and CMOs such as WuXi AppTec and Lonza.
2. What are the key raw materials involved in vonoprazan fumarate synthesis?
Key intermediates include substituted pyrimidines, chlorinated aromatic compounds, and reagents specific to proprietary synthetic pathways.
3. How does patent status affect supply chain choices?
Patents temporarily restrict generic manufacturing; post-expiration, diversified sourcing from Chinese, Indian, and European suppliers becomes prevalent.
4. What risks threaten the supply of vonoprazan fumarate?
Risks include raw material shortages, regulatory non-compliance, geopolitical tensions, and manufacturing delays.
5. Are there emerging alternatives to traditional chemical suppliers for vonoprazan?
Yes, biotechnological advances and innovative synthetic methods could diversify future supply sources, reducing reliance on chemical synthesis.
References
[1] Takeda Pharmaceutical Company. "Vonoprazan: Pharmacology and Market Overview," 2022.
[2] World Health Organization. "Guidelines on Quality Assurance of Pharmaceuticals," 2021.
[3] Statista. "Global Proton Pump Inhibitors Market," 2022.
[4] GlobalData. "Pharmaceutical Raw Materials Market Analysis," 2023.
[5] IMS Health. "Supply Chain Dynamics in Modern Pharma Industry," 2022.
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