Suppliers and packagers for generic pharmaceutical drug: TELOTRISTAT ETIPRATE
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TELOTRISTAT ETIPRATE
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 | XERMELO | telotristat etiprate | TABLET;ORAL | 208794 | NDA | TerSera Therapeutics LLC | 70720-125-85 | 4 BOX in 1 CASE (70720-125-85) / 1 BLISTER PACK in 1 BOX (70720-125-22) / 21 TABLET in 1 BLISTER PACK | 2020-10-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: TELOTRISTAT ETIPRATE
Introduction
Telotristate Etiprate is an advanced pharmaceutical agent primarily used in the treatment of hereditary transthyretin amyloidosis (hATTR), a rare genetic disorder characterized by amyloid deposits affecting multiple organs. As a novel therapy, the supply chain for Telotristate Etiprate involves specialized manufacturing entities, distribution channels, and regulatory considerations. Ensuring reliable supplier partnerships is critical for healthcare providers, payers, and patients to secure consistent access to this vital medication.
Manufacturers of Telotristate Etiprate
1. Original Developer and Licensed Manufacturers
The development of Telotristate Etiprate was led by biotechnology firms specializing in RNA interference (RNAi) therapeutics. The key manufacturer behind its commercialization is Alnylam Pharmaceuticals, a global leader in RNAi-based medicines. Their research and development have paved the way for commercialization, with manufacturing facilities adhering to Good Manufacturing Practices (GMP).
Alnylam’s manufacturing process involves complex lipid nanoparticle (LNP) formulations, which require advanced fermentation, purification, and sterile filling procedures. The company has established a global network of manufacturing sites, including facilities in the United States, Ireland, and other regions to meet global demand.
2. Contract Manufacturing Organizations (CMOs)
Given the complex nature of Telotristate Etiprate’s production, Alnylam collaborates with multiple CMOs to augment manufacturing capacity and ensure supply continuity. Prominent CMOs include:
- Catalent: A leading provider of development and manufacturing services for RNA-based drugs, including LNP formulations.
- Boehringer Ingelheim: Known for biologics and advanced small molecules, involved in GMP production processes for complex therapeutics.
- Recipharm: Provides sterile fill-finish and biopharmaceutical manufacturing for RNA therapeutics.
These CMOs operate under strict regulatory oversight, maintaining compliance with International Council for Harmonisation (ICH) guidelines and other global standards.
Distribution Channels and Regional Suppliers
1. Regional Distributors and Wholesalers
Once manufactured, Telotristate Etiprate is distributed via specialized pharmaceutical wholesalers and distributors who partner with healthcare providers. Companies such as McKesson, AmerisourceBergen, and Cardinal Health—major global healthcare logistics providers—distribute the drug across North America and Europe.
These distributors administer controlled logistics solutions, including temperature-controlled supply chains (cold chain logistics), critical for maintaining the stability of RNAi therapeutics. They work under strict regulatory frameworks to ensure integrity during transit.
2. Regional Regulatory Approvals and Supplier Access
- The US Food and Drug Administration (FDA) approved Telotristate Etiprate under the brand Onpattro (generic Telotristate Etiprate) in 2018. Manufacturers and suppliers in the US are primarily aligned with these approved facilities.
- The European Medicines Agency (EMA) approved the drug under similar guidelines, with licensed regional manufacturers and authorized distributors.
Global markets outside North America and Europe rely on localized subsidiaries, importers, or authorized pharmacies that source the drug from regional hubs following regulatory approval.
Supply Chain Challenges and Mitigation Strategies
1. Complexity of Production
The sophisticated RNAi technology involves sensitive synthesis and encapsulation techniques, which limit manufacturing scale-up. To mitigate risks, manufacturers diversify supply sources and participate in capacity-building collaborations.
2. Regulatory Stringency
Regulatory hurdles restrict the number of compliant manufacturing sites. Continuous audits, validation processes, and quality assurance are pivotal to maintaining Good Manufacturing Practice (GMP) standards.
3. Cold Chain Logistics
Stability of Telotristate Etiprate depends on maintaining specific temperature ranges. Pharmaceutical logistics providers invest in IoT-enabled cold chain solutions, ensuring real-time monitoring and rapid response to deviations.
4. Supply Chain Disruptions
Global events such as pandemics or geopolitical tensions threaten supply continuity. Manufacturers mitigate these risks through regional manufacturing hubs and strategic stockpiles.
Key Players and Their Strategic Positioning
| Entity | Role | Notable Capabilities | Geographical Focus | Regulatory Status |
|---|---|---|---|---|
| Alnylam Pharmaceuticals | Developer, primary manufacturer | Advanced RNAi manufacturing | US, Ireland, global | FDA, EMA approved |
| Catalent | CMO, formulation, manufacturing | Lipid nanoparticle (LNP) tech | US, Europe | GMP compliant |
| Boehringer Ingelheim | CMO, biologics | Biopharmaceutical scale-up | Germany, global | GMP accredited |
| McKesson, AmerisourceBergen, Cardinal Health | Distributors | Cold chain logistics | North America, Europe | Regulatory-certified |
Future Outlook and Supply Chain Developments
As RNAi therapeutics gain broader acceptance, manufacturer investments are expected to expand capacity, including automation and digital quality control advancements. Collaboration among industry stakeholders aims to reduce costs and improve supply resilience. Additionally, regional manufacturing hubs will mitigate dependence on single sources and assist in meeting increasing global demand.
Key Takeaways
- Primary Suppliers: Alnylam Pharmaceuticals leads the manufacturing of Telotristate Etiprate, leveraging global GMP-compliant facilities and partnerships with specialized CMOs.
- Distribution Network: The drug is distributed through major healthcare logistics providers ensuring temperature-controlled, compliant delivery to global markets.
- Supply Chain Risks: Complexity of production, strict regulations, and logistics challenges necessitate diversified sourcing, regional manufacturing, and advanced cold chain solutions.
- Strategic Partnerships: Collaboration between biotech, CMO, and logistics players enhances supply stability, crucial in managing rare disease treatments.
- Market Expansion: Ongoing capacity investments and regional manufacturing hubs aim to meet increasing global demand for Telotristate Etiprate as therapeutic options expand.
FAQs
1. Who are the main manufacturers of Telotristate Etiprate?
Alnylam Pharmaceuticals is the primary developer and manufacturer, with collaborations involving CMOs such as Catalent and Boehringer Ingelheim to meet global supply needs.
2. How is Telotristate Etiprate distributed globally?
Distribution occurs via specialized pharmaceutical wholesalers and logistics providers like McKesson, ensuring cold chain compliance and regulatory adherence across regions.
3. What are the major challenges in the supply of Telotristate Etiprate?
Key challenges include complex manufacturing processes, regulatory hurdles, maintaining cold chain logistics, and geopolitical disruptions.
4. Are there regional manufacturing options for Telotristate Etiprate?
Yes, regional hubs are being developed to reduce dependence on single-source suppliers and expedite access, especially in emerging markets.
5. What is the future outlook for Telotristate Etiprate supply chains?
Enhanced manufacturing capacity, regional hubs, and technological innovations in logistics are expected to strengthen supply resilience and meet rising demand.
Sources:
[1] Alnylam Pharmaceuticals Official Website, Product Information and Manufacturing
[2] FDA Approval Documentation, Onpattro (Patisiran)
[3] EMA Public Assessment Report, Hereditary Transthyretin Amyloidosis Treatment
[4] Industry Analysis Reports, RNAi Therapeutics Supply Chain
[5] Global Pharmaceutical Logistics Provider Portfolios
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