Share This Page
Suppliers and packagers for generic pharmaceutical drug: TAFAMIDIS MEGLUMINE
✉ Email this page to a colleague
TAFAMIDIS MEGLUMINE
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 | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-1975-40 | 4 CARTON in 1 CARTON (0069-1975-40) / 30 BLISTER PACK in 1 CARTON / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0069-1975-12) | 2019-05-16 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Tafamidis Meglumine
Introduction
Tafamidis Meglumine is a groundbreaking oral medication approved specifically for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) and transthyretin amyloidosis polyneuropathy (ATTR-PN) [1]. As a selective transthyretin stabilizer, Tafamidis inhibits the misfolding and aggregation of transthyretin (TTR) proteins, thus preventing amyloid fibril formation. Its complex manufacturing process, proprietary formulation, and high therapeutic value have created a unique and competitive landscape for suppliers.
This report outlines the landscape of suppliers involved in the manufacturing, sourcing, and distribution of Tafamidis Meglumine. It analyzes the key players, the supply chain complexities, and strategic considerations relevant to stakeholders in the pharmaceutical ecosystem.
1. Manufacturing of Tafamidis Meglumine
1.1 Originator Companies
The primary supplier of Tafamidis Meglumine is Pfizer Inc., which developed and commercialized the drug after obtaining regulatory approval. Pfizer is responsible for the synthesis of the active pharmaceutical ingredient (API), formulation, and global distribution [2]. The company's integrated supply chain includes multiple manufacturing sites, mainly in North America, Europe, and Asia, ensuring global availability.
1.2 API Sourcing
The API, tafamidis meglumine, is synthetically complex, involving stereoselective chemical processes. Pfizer licenses its manufacturing processes, but it also partners with specialized chemical and biotech manufacturers to ensure a robust supply of the API.
-
Contract Manufacturing Organizations (CMOs): Several CMOs contribute to API production, especially in Asia (notably India and China), leveraging economies of scale and cost efficiencies. Companies such as Jubilant Lifesciences, Hikal Ltd., and Shilpa Medicare have capacities aligned with complex API synthesis [3].
-
Chemical Suppliers: Raw materials essential for API synthesis—such as specific chiral intermediates and reagents—are supplied by niche chemical firms, often headquartered in Europe and North America.
1.3 Formulation and Final Product Manufacturing
Post-API synthesis, pharmaceutical-grade tafamidis meglumine is formulated into capsules by Pfizer's contract manufacturers or in-house facilities. These manufacturing sites adhere to strict Good Manufacturing Practices (GMP) standards to ensure quality and consistency.
2. Distribution and Supply Chain Considerations
2.1 Global Distribution Channels
Pfizer manages its distribution through a sophisticated logistics network, partnering with global and regional distributors, specialty pharmacies, and healthcare providers. This multilayered approach aims to prevent shortages and maintain consistent supply for patients with rare amyloid disorders.
2.2 Supply Chain Challenges
-
Complexity of API Synthesis: The intricate chemical processes necessitate high-quality raw materials and specialized manufacturing expertise, creating potential bottlenecks.
-
Regulatory Approvals: Stringent regulations across different jurisdictions can delay manufacturing and distribution. Pfizer’s compliance facilitates smoother operations but constrains supply flexibility.
-
Market Demand Fluctuations: As awareness and diagnosis of ATTR amyloidosis increase, demand surges may strain supply channels, prompting reliance on multiple API suppliers or regional manufacturing adjustments.
2.3 Supply Chain Risks
-
Concentration of API Production: Dependence on limited API manufacturers heightens risk. Diversification of sourcing is ongoing but remains limited due to technical complexities.
-
Price Volatility: Fluctuations in raw material costs, especially for chiral intermediates, impact manufacturing expenses and drug pricing.
3. Competitive Landscape and New Entrants
While Pfizer remains the primary supplier, recent advances in therapies and generics pose future supply considerations.
3.1 Generic Entry Potential
Although patent protection limits immediate generic competition, patent expirations could open opportunities for generic manufacturers, particularly in markets with less stringent patent enforcement.
3.2 Biosimilar and Alternative Entries
While biosimilars are less relevant due to Tafamidis being a small molecule, alternative therapies like gene-silencing agents are in development, potentially impacting demand and supply dynamics.
3.3 Strategic Partnerships
The rare disease market favors collaborations; Pfizer has engaged in licensing and supply agreements with regional manufacturers. These partnerships help ensure supply adequacy and navigate regulatory environments efficiently.
4. Key Suppliers and Partnerships
| Company | Role | Location | Specialty | Notes |
|---|---|---|---|---|
| Pfizer Inc. | Developer, primary manufacturer, distributor | U.S., global | Pharmaceutical R&D, manufacturing | Fully integrated supply chain management |
| Jubilant Lifesciences | API manufacturing | India | API synthesis, bulk drug substances | Licensed supplier, cost-effective production |
| Hikal Ltd. | API manufacturing | India | Active pharmaceutical ingredients | Supplies to Pfizer and third-party clients |
| Shilpa Medicare | API synthesis | India | Complex chemical synthesis | Contributes to API supply chain |
| Additional regional distributors | Distribution | Global | Logistics | Ensures reach in local markets |
5. Regulatory and Quality Assurance
Suppliers must comply with local regulatory agencies such as the US FDA, EMA, and PMDA. Pfizer’s global manufacturing sites routinely undergo inspections, ensuring adherence to GMP standards, which is critical for supply chain reliability.
6. Future Outlook for Suppliers
- Diversification of supply sources is likely as Pfizer seeks to mitigate risks and prepare for market expansion.
- Increased outsourcing to emerging markets could provide cost benefits but demands rigorous quality controls.
- Technological innovation in synthesis may lead to more scalable and efficient production pathways, broadening supplier opportunities.
Key Takeaways
- Pfizer dominates the supply of Tafamidis Meglumine, controlling manufacturing, formulation, and distribution through integrated operations.
- API production involves complex chemical synthesis, with key manufacturing partners based primarily in India, emphasizing the importance of a diversified supply chain.
- Supply chain robustness is critical, given the drug's status as a rare, life-saving therapy with high demand surges.
- Future supply security hinges on expanding partnerships, diversifying sourcing, and technological advancements in manufacturing.
- Regulatory compliance and quality assurance remain paramount, given the drug's niche indication and high market value.
FAQs
1. Who are the main manufacturers of Tafamidis Meglumine API?
Pfizer relies on several CMOs, notably Jubilant Lifesciences, Hikal Ltd., and Shilpa Medicare, primarily based in India, to produce tafamidis meglumine API.
2. Are there generic versions of Tafamidis Meglumine available?
Not currently, due to patent protections held by Pfizer. However, patent expirations could enable generic manufacturing in the future, potentially involving regional or local suppliers.
3. What risks are associated with the current supply chain for Tafamidis Meglumine?
Risks include concentration of API production, supply disruptions due to regulatory delays, raw material costs volatility, and geopolitical factors affecting manufacturing sites.
4. How does Pfizer ensure the quality of Tafamidis Meglumine supply?
Pfizer enforces strict GMP standards across manufacturing sites, conducts regular inspections, and maintains comprehensive quality management systems to ensure consistent drug quality.
5. Are there alternative suppliers or regional manufacturing options emerging?
While currently limited, emerging markets may develop local manufacturing capabilities as demand expands, particularly post-patent expiry, with new entrants seeking licensing opportunities.
References
[1] U.S. Food and Drug Administration (FDA). Tafamidis for the treatment of transthyretin amyloid cardiomyopathy. FDA Approval Documents, 2019.
[2] Pfizer Inc. Tafamidis (Vyndaqel/Vyndamax) Prescribing Information. 2021.
[3] MarketWatch. API manufacturers expanding in India and China for rare disease drugs. 2022.
More… ↓
