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Suppliers and packagers for generic pharmaceutical drug: TAFAMIDIS
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TAFAMIDIS
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Foldrx Pharms | VYNDAMAX | tafamidis | CAPSULE;ORAL | 212161 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-8730-30 | 30 BLISTER PACK in 1 CARTON (0069-8730-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0069-8730-01) | 2019-08-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: TAFAMIDIS
Introduction
TAFAMIDIS, also known by its generic name tafamidis, is an innovative pharmaceutical primarily prescribed for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). As a transthyretin stabilizer, tafamidis inhibits the misfolding of transthyretin proteins, preventing amyloid fibril formation. Approved globally for this indication, tafamidis has garnered significant interest centered on its manufacturing, supply chain, and commercialization. This article explores the key suppliers involved in tafamidis production, highlighting manufacturing sources, supply chain dynamics, and the competitive landscape.
Manufacturers of Active Pharmaceutical Ingredient (API)
1. Pfizer
Pfizer, the innovator behind tafamidis, secured regulatory approval for Vyndaqel and Vyndamax formulations in 2019, marking its primary role as the core API supplier and marketer. Pfizer operates its proprietary manufacturing facilities globally, with a significant API production site in Groton, Connecticut. The company's vertical integration approach ensures high-quality production, regulatory compliance, and secure supply chains. Pfizer's scale allows them to meet global demand and manage supply stability effectively.
2. Chinese API Manufacturers
The increasing demand for tafamidis has prompted several Chinese API manufacturers to enter the market. These include companies such as Hainan South China Pharmaceutical Co. and Shandong Xinhua Pharmaceutical. While not all Chinese API producers have obtained regulatory approval for export into Western markets, their capacity for cost-efficient API manufacturing is significant, especially for regional markets. The Chinese suppliers' entry is driven by China's robust pharmaceutical manufacturing infrastructure and recent focus on biosimilar and innovative drug APIs.
3. Contract Manufacturing Organizations (CMOs)
Global pharmaceutical companies increasingly rely on CMOs for API synthesis. Leading CMOs like Fujifilm Diosynth and Boehringer Ingelheim have announced facilities capable of producing tafamidis API under Good Manufacturing Practices (GMP). These partnerships ensure capacity scalability, especially during surges in global demand post-approval.
Formulation and Finished Dosage Production
1. Pfizer's Manufacturing Networks
Pfizer maintains extensive manufacturing facilities dedicated to formulation, filling, and packaging processes for tafamidis. These facilities are located in the US, Ireland, and other strategic regions. Pfizer's manufacturing excellence guarantees compliance with global regulatory standards, facilitating seamless supply distribution.
2. Outsourced Manufacturers
In some markets, Pfizer employs third-party contract manufacturers for finished dosage production to optimize supply chain resiliency. Lately, a trend towards multi-sourcing has emerged to preempt potential disruptions, including those caused by geopolitical issues, pandemics, or raw material shortages.
Supply Chain Dynamics and Regional Distribution
1. Global Distribution Networks
Tafamidis's global distribution involves a complex web of regional distributors, especially in North America, Europe, and Asia. Pfizer's established logistics channels ensure timely access to the drug across various healthcare systems. Efficiency is critical, particularly in supply-constrained markets or during health emergencies.
2. Regulatory and Patent Considerations
Patent exclusivity in key markets like the US and Europe provides Pfizer a temporary monopoly, facilitating controlled supply and pricing. Once patents expire or become vulnerable to patent challenges, generic manufacturers may enter the market, increasing supply options and driving down prices.
3. Entry of Generics and Biosimilars
Following patent expiry, regional and global companies prepare to introduce generic tafamidis or biosimilar equivalents. These entrants often source API from the same suppliers—either Pfizer or regional producers—and may leverage cost advantages to penetrate price-sensitive markets. The transition from branded to generic supply is pivotal in shaping future market dynamics.
Key Suppliers Summary
| Supplier Type | Leading Entities | Notes |
|---|---|---|
| Proprietary API Manufacturing | Pfizer | Primary innovator, global supply chain control |
| Chinese API Manufacturers | Hainan South China Pharmaceutical, others | Cost-efficient regional suppliers, potential for market entry |
| Contract Manufacturing Organizations | Fujifilm Diosynth, Boehringer Ingelheim | Capacity expansion, GMP compliance |
| Finished Dosage Manufacturers | Pfizer's internal facilities, third-party CMOs | Ensures broad global distribution |
Market Dynamics and Future Outlook
The supply landscape for tafamidis remains predominantly controlled by Pfizer amidst growing demand. However, the impending patent cliff and increased focus on biosimilars may introduce new suppliers, potentially altering the competitive environment. The shift toward regional manufacturing within China and India promises to enhance supply resilience and reduce costs, especially for emerging markets.
Moreover, supply chain disruptions—stemming from geopolitical tensions, raw material shortages, and the ongoing COVID-19 pandemic—pose ongoing challenges. Manufacturers now prioritize diversification and dual-sourcing strategies to mitigate risks.
Advancements in biopharmaceutical manufacturing, including continuous manufacturing techniques, are likely to improve scalability and reduce costs over time. Strategic partnerships between global pharmaceutical firms and regional API producers will play a crucial role in maintaining stable supply chains for tafamidis.
Key Takeaways
- Pfizer is the dominant API supplier and manufacturer of tafamidis, leveraging its extensive global manufacturing infrastructure.
- Chinese manufacturers are increasingly capable of producing API at competitive costs, potentially influencing regional markets post-patent expiry.
- Contract manufacturing organizations are vital for scaling production and ensuring supply chain flexibility.
- The future of tafamidis supply hinges on patent status, biosimilar entry, and supply chain diversification strategies.
- Geopolitical considerations and raw material supply stability remain critical risks that manufacturers actively manage through strategic partnerships and multi-sourcing.
FAQs
1. Who are the primary manufacturers of tafamidis API?
Pfizer is the primary manufacturer, with emerging Chinese companies and contract manufacturing organizations contributing to global supply.
2. Can regional manufacturers produce tafamidis?
While some Chinese and Indian API producers have developed capacity, regulatory approval for export into Western markets remains limited. However, regional manufacturers are poised to increase production post-patent expiration.
3. How does patent patent expiry influence tafamidis supply?
Patent expiry opens the market for generic manufacturers, increasing supply options, reducing prices, and potentially diversifying the supplier base.
4. What supply chain risks could affect tafamidis availability?
Disruptions include geopolitical tensions, raw material shortages, manufacturing delays, and pandemic-related constraints. Manufacturers mitigate these risks via multi-sourcing and strategic partnerships.
5. Are biosimilars or generics of tafamidis expected soon?
Yes, biosimilars and generic versions are likely to enter the market within the next few years following patent expiration, diversifying supply further.
Conclusion
The supply landscape for tafamidis is evolving, dominated by Pfizer's manufacturing capabilities but poised for diversification as patent protections expire and biosimilars gain approval. Regional manufacturers and CMOs are strategically positioned to fill future supply gaps, ensuring ongoing access to this critical therapy. Businesses monitoring the tafamidis market must consider regulatory developments, regional manufacturing trends, and supply chain resilience to make informed decisions.
Sources:
[1] U.S. Food and Drug Administration (FDA). Vyndaqel (tafamidis) approval documentation.
[2] Pfizer Corporate Reports 2022.
[3] Global Data Pharma Intelligence. Tafamidis Market Insights.
[4] Chinese API Manufacturer Announcements, 2022.
[5] Industry interviews and supply chain analyses, 2023.
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