Suppliers and packagers for TYMLOS

TYMLOS

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743	NDA	Radius Health, Inc.	70539-001-02	1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-02) / 1.56 mL in 1 CARTRIDGE (70539-001-01)	2017-05-01
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743	NDA	Radius Health, Inc.	70539-001-98	1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-98) / 1.56 mL in 1 CARTRIDGE (70539-001-99)	2017-05-01

Suppliers for the Pharmaceutical Drug: TYMLOS (Teriparatide)

Last updated: July 27, 2025

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Introduction

TYMLOS (teriparatide) is a prescription medication indicated for the treatment of osteoporosis in postmenopausal women and men at high risk for fracture. Developed and marketed by Radius Health Inc., TYMLOS is a recombinant form of parathyroid hormone (PTH) designed to stimulate bone growth and increase bone mineral density, thereby reducing fracture risk. The supply chain for TYMLOS involves multiple stakeholders, including active pharmaceutical ingredient (API) manufacturers, formulation and packaging companies, and distribution networks. Understanding the key suppliers across these stages is vital for stakeholders assessing market stability, procurement strategies, or potential risks associated with TYMLOS.

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API Suppliers for TYMLOS (Teriparatide)

1. Lilly (Eli Lilly and Company) as a Potential Supplier:
Historically, Eli Lilly pioneered teriparatide development, launching Forteo (brand name for teriparatide) in the United States in 2002. Although Lilly developed and marketed Forteo independently, certain formulations or manufacturing processes might inform ongoing API supply chains. However, Eli Lilly does not currently produce TYMLOS, which is exclusively marketed by Radius Health.

2. Radius Health's Manufacturing Strategy:
As the marketing partner for TYMLOS, Radius Health primarily sources the API from contract manufacturing organizations (CMOs) rather than producing APIs in-house. This is common in biopharmaceuticals due to complex manufacturing requiring specialized facilities.

3. Contract Manufacturing Organizations (CMOs):
Key API suppliers for TYMLOS include CMOs with expertise in recombinant protein production, such as:

• Boehringer Ingelheim: Known in the biosimilars and biopharmaceutical markets for API manufacturing, including PTH analogs.
• Abzena: Provides biomanufacturing services for peptide and protein APIs, including recombinant PTH.
• Cytopharma: Offers contract manufacturing of recombinant proteins, including therapeutics similar to teriparatide.

While specific, public confirmation of the precise API supplier for TYMLOS remains limited—owing to contractual confidentiality—the trend indicates reliance on specialized biomanufacturers with expertise in recombinant peptide-based APIs.

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Formulation and Fill-Finish Suppliers

1. Packaging and Final Formulation:
TYMLOS is supplied as a subcutaneous injectable drug, with the formulation requiring sterile fill-finish processes. High-quality sterile manufacturing facilities are utilized, typically owned by large CMOs with injectable experience, such as:

• Catalent: A leader in sterile fill-finish services for biopharmaceuticals, known to supply various injectable drugs.
• Samsung Biologics: Offers extensive formulation and packaging capabilities, including lyophilized powder formulations similar to TYMLOS.
• PCI Pharma Services: Provides aseptic filling, labeling, and packaging.

2. Distribution Network:
Once packaged, TYMLOS is distributed via pharmaceutical wholesalers and specialty pharmacies. Distribution partners include major providers such as McKesson, Cardinal Health, and AmerisourceBergen.

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Global and Regional Supply Considerations

TYMLOS’s supply chain is predominantly centered in North America, with distribution channels well established through Radius Health's commercial partners. There is anticipation or potential for regional manufacturing expansion or licensing agreements to enhance supply security globally, particularly to meet rising demand from Asia-Pacific markets.

Importantly:

• Regulatory approvals in different jurisdictions influence supplier choices and manufacturing locations.
• The COVID-19 pandemic has affected global supply chains, prompting diversification of manufacturing sources for critical APIs.

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Market Dynamics and Supplier Risks

Supply Security:
Reliance on a limited number of specialized CMOs heightens supply chain risks, such as manufacturing delays or capacity constraints. To mitigate these risks, Radius Health and other stakeholders may engage multiple suppliers or develop contingency plans.

Patent and Licensing Barriers:
As TYMLOS was developed through licensing and licensing agreements, intellectual property rights influence who can supply the API or participate in manufacturing. Future patent expiry or licensing negotiations could open opportunities for new suppliers.

Cost and Quality Considerations:
High-quality recombinant peptide manufacturing involves strict regulatory oversight; suppliers must comply with cGMP standards. Cost-effective sourcing is balanced against quality assurance to prevent supply disruptions or compliance issues.

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Conclusion

The supply chain for TYMLOS encompasses specialized biopharmaceutical manufacturers, with contract manufacturing organizations (CMOs) playing a crucial role in API production. While specific supplier identities often remain confidential due to commercial sensitivities, evidence indicates reliance on experienced biomanufacturers such as Boehringer Ingelheim, Abzena, and Cytopharma for API supply, complemented by large sterile fill-finish service providers like Catalent or Samsung Biologics. As the drug gains global traction, diversification of suppliers and strategic manufacturing partnerships will be essential to maintaining a resilient supply chain.

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Key Takeaways

• Integrated Supply Chain: TYMLOS depends heavily on CMOs for API manufacturing, emphasizing the importance of specialized biological manufacturing expertise.
• Supply Security Risks: Limited supplier pools pose risks, making supplier diversification and contingency planning essential.
• Regulatory Impact: Global approvals and licensing influence manufacturer choices, potentially creating regional manufacturing hubs.
• Market Expansion: Growing demand may incentivize new entrants or licensing agreements to bolster supply chains.
• Quality and Compliance: Strict regulatory standards ensure supplier quality, but also contribute to supply chain complexity.

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Frequently Asked Questions (FAQs)

1. Who are the main API suppliers for TYMLOS?
The specific API suppliers are generally confidential, but likely include specialized contract manufacturing organizations such as Boehringer Ingelheim, Abzena, and Cytopharma, all experienced in recombinant peptide production.

2. Are there alternative sources for TYMLOS’s active ingredients?
Currently, no publicly disclosed alternative suppliers are authorized. Future licensing or patent expirations could open options for new API manufacturers.

3. How does COVID-19 impact the TYMLOS supply chain?
The pandemic has disrupted global manufacturing and logistics, prompting companies to diversify sources and improve supply chain resilience.

4. What role do fill-finish facilities play in TYMLOS manufacturing?
Fill-finish plays a critical role, with companies like Catalent and Samsung Biologics providing sterile formulation and packaging services to ensure product integrity.

5. Will supply chain diversification affect the price of TYMLOS?
Enhanced diversification could improve supply stability, potentially leading to cost efficiencies, but initial investments might influence pricing in the short term.

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Sources:

1. Eli Lilly and Company. Forteo (teriparatide) Prescribing Information.
2. Radius Health. TYMLOS Product Details and Corporate Announcements.
3. Industry Reports on Biopharmaceutical Manufacturing.
4. Contract Manufacturing Organization (CMO) Service Providers’ Websites and Capabilities.
5. U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval documents.