Suppliers and packagers for forteo

forteo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318	NDA	Eli Lilly and Company	0002-8400-01	1 SYRINGE in 1 CARTON (0002-8400-01) / 2.24 mL in 1 SYRINGE	2002-11-26
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318	NDA	Eli Lilly and Company	0002-9678-01	1 SYRINGE in 1 CARTON (0002-9678-01) / 2.24 mL in 1 SYRINGE	2025-06-03
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-495-28	1 SYRINGE in 1 CARTON (66993-495-28) / 2.24 mL in 1 SYRINGE	2023-11-17
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-989-28	1 SYRINGE in 1 CARTON (66993-989-28) / 2.24 mL in 1 SYRINGE	2025-06-16

Suppliers for the Pharmaceutical Drug: FORTEO

Last updated: July 29, 2025

Introduction

Forteo (teriparatide) is a groundbreaking anabolic agent used primarily to treat osteoporosis, especially in postmenopausal women and individuals at high risk of fractures. Since its approval by the U.S. Food & Drug Administration (FDA) in 2002, Forteo has become a vital part of osteoporosis management. The drug's manufacturing and supply chain involve a complex network of raw material providers, contract manufacturing organizations (CMOs), and distributors globally. This article provides an in-depth analysis of the key suppliers involved in the production and distribution of Forteo, outlining their roles, market significance, and implications for stakeholders.

Overview of Forteo Manufacturing and Supply Chain

Forteo is a recombinant DNA (rDNA) peptide identical to human parathyroid hormone (PTH 1-34). Its production involves advanced biotechnological processes, including the synthesis of the active ingredient, formulation, filling, and packaging. These processes require high-quality raw materials, sophisticated manufacturing facilities, and stringent quality control protocols regulated under strict pharmaceutical standards.

The entire supply chain can be segmented into:

• Raw Material Suppliers: Providers of amino acids, culture media, and other critical components for recombinant protein synthesis.
• Active Pharmaceutical Ingredient (API) Manufacturers: Facilities producing the teriparatide peptide.
• Formulation and Fill-Finish Suppliers: Organizations responsible for turning the API into a finished injectable product.
• Distribution Networks: Distributors and wholesalers ensuring global supply, especially within the U.S., Europe, and emerging markets.

Key Raw Material Suppliers

The production of recombinant proteins like Forteo relies heavily on high-quality raw materials. Amino acids, culture media components, and cell line media are essential. Major suppliers include:

1. Thermo Fisher Scientific

Thermo Fisher Scientific supplies critical raw materials for the bioreactor media used in recombinant protein manufacturing. Their extensive portfolio supports large-scale biotech production, including amino acids, vitamins, and growth factors necessary for cultivating genetically engineered cells.

2. Merck KGaA (MilliporeSigma in North America)

Merck offers cell culture media, process chemicals, and validation kits. Their contributions support the upstream production processes that generate teriparatide.

3. Fujifilm Wako Chemicals

Fujifilm supplies specialty chemicals and reagents for protein purification, crucial during the API manufacturing phase of Forteo.

Active Pharmaceutical Ingredient (API) Suppliers

The core of Forteo's supply chain involves specialized biotech firms capable of biosynthetic peptide production under cGMP standards.

4. Eli Lilly and Company

Eli Lilly developed Forteo and remains a primary manufacturer of the drug. They operate multiple manufacturing plants globally dedicated to the production of teriparatide, ensuring supply security for the global market.

5. Formosa Plastics Corporation

Although primarily a plastics manufacturer, Formosa Plastics supplies materials such as bioreactor tubing and related devices used in API production lines, indirectly influencing the supply chain.

6. Contract Manufacturing Organizations (CMOs)

In some cases, Eli Lilly collaborates with CMOs for certain production segments, such as peptide synthesis or filling operations, to meet global demand efficiently.

Formulation and Fill-Finish Suppliers

Once the API is synthesized, it undergoes formulation and filling into pre-filled syringes. Specialized contract organizations perform these tasks:

7. Catalent Pharma Solutions

Catalent provides expertise in sterile filling, packaging, and delivery device integration. Their advanced facilities enable high-throughput filling of Forteo injections with rigorous quality assurance.

8. Patheon (a part of Thermo Fisher Scientific)

Patheon offers GMP-compliant fill-finish services, especially for subcutaneous injectables like Forteo.

Distribution and Logistics

Distribution of Forteo is handled through global pharmaceutical distribution networks that connect manufacturers to healthcare providers and pharmacies. Major distributors include:

9. McKesson Corporation

McKesson supplies Forteo to U.S. healthcare providers, maintaining cold chain logistics to ensure drug stability.

10. Cardinal Health

Cardinal Health distributes Forteo across the U.S. and globally, ensuring regulatory compliance and timely delivery.

11. Global Distributors

In emerging markets, regional distributors, such as Alibaba Health and local pharmaceutical wholesalers, facilitate access to Forteo, especially where Eli Lilly's direct presence is limited.

Market Dynamics and Supplier Considerations

Supply Security

Eli Lilly’s vertical integration minimizes supply disruptions for Forteo. However, reliance on specific raw materials from limited suppliers poses risks, such as supply chain interruptions or geopolitical issues. Diversification, strategic stockpiles, and supply chain resilience are key considerations.

Regulatory Compliance

Suppliers must adhere to strict cGMP standards mandated by regulators such as the FDA, EMA, and PMDA. Quality control and validation are critical to maintaining consistent product standards and avoiding costly recalls.

Innovation and Capacity Expansion

Eli Lilly continues investing in capacity expansion and process optimization to meet increasing demand, supported by collaborations with third-party CMOs and raw material suppliers.

Implications for Stakeholders

• Pharmaceutical Companies: Ensuring stability in raw material procurement and selecting reliable manufacturing partners are essential for uninterrupted Forteo supply.
• Investors: The supply chain's robustness influences Lilly’s market position and profitability.
• Healthcare Providers: Availability depends on supply chain efficiency and distributor responsiveness.
• Patients: Access to Forteo hinges on the global capacity of key suppliers and logistics operations.

Key Takeaways

• The production of Forteo involves a sophisticated supply chain integrating raw material suppliers, active pharmaceutical ingredient manufacturers, formulation and fill-finish organizations, and distributors.
• Eli Lilly, as the primary manufacturer, maintains significant control but relies on a network of trusted suppliers for critical inputs.
• Ensuring supply chain resilience requires diversification of raw material sources, continuous capacity investments, and adherence to regulatory standards.
• Strategic partnerships with CMOs and raw material vendors are vital for scaling up production and maintaining market supply.
• Disruptions at any point—be it raw materials, manufacturing, or distribution—can impact drug availability, underscoring the importance of supply chain agility.

FAQs

1. Who are the main manufacturers of Forteo?
Eli Lilly & Company is the primary manufacturer, overseeing the production, formulation, and global distribution of Forteo.

2. What raw materials are critical for Forteo production?
Amino acids, cell culture media components, and reagents for protein purification are vital raw materials supplied by companies like Thermo Fisher Scientific and Merck KGaA.

3. How does Eli Lilly ensure supply chain security for Forteo?
Through vertical integration, diversified supplier relationships, strategic stockpiling, and capacity investments, Lilly maintains a robust supply chain.

4. Are there third-party manufacturing partners involved?
Yes, Eli Lilly collaborates with Contract Manufacturing Organizations (CMOs) for certain production stages, such as peptide synthesis and fill-finish operations.

5. What are the risks associated with Forteo supply chain disruptions?
Risks include raw material shortages, manufacturing delays, logistical challenges, and regulatory compliance issues, all of which can affect drug availability.

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Sources

1. U.S. Food & Drug Administration (FDA). Forteo (teriparatide) prescribing information. 2002.
2. Eli Lilly and Company. Forteo Product Information. 2023.
3. Pharmaceutical Technology. Biotech raw materials procurement and quality control. 2022.
4. Contract Pharma. CMOs in biologics manufacturing: partnerships and capacity. 2023.
5. Logistics Management. Cold chain distribution for temperature-sensitive biologics. 2022.