Suppliers and packagers for TERIPARATIDE

TERIPARATIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apotex	TERIPARATIDE	teriparatide	SOLUTION;SUBCUTANEOUS	211097	ANDA	Apotex Corp.	60505-6188-0	1 SYRINGE in 1 CARTON (60505-6188-0) / 2.4 mL in 1 SYRINGE	2023-11-16
Teva Pharms Usa	TERIPARATIDE	teriparatide	SOLUTION;SUBCUTANEOUS	208569	ANDA	Teva Pharmaceuticals USA, Inc.	0093-1106-16	1 SYRINGE in 1 CARTON (0093-1106-16) / 2.24 mL in 1 SYRINGE	2023-12-18

Suppliers for the Pharmaceutical Drug: Teriparatide

Last updated: July 28, 2025

Introduction

Teriparatide is a recombinant human parathyroid hormone (PTH), used primarily for the treatment of osteoporosis in postmenopausal women and men at high fracture risk. Its unique anabolic mechanism stimulates bone formation, distinguishing it from other osteoporosis therapies. Due to its critical role in bone health management, the supply chain for teriparatide is of strategic importance to healthcare providers, pharmaceutical companies, and patients. This article provides a comprehensive overview of the leading suppliers of teriparatide, the landscape of manufacturing, and the dynamics affecting global supply.

Manufacturers of Teriparatide

Eli Lilly and Company

Eli Lilly pioneered the commercial development of teriparatide, marketing it under the brand name Forteo (in the United States) and Vijoice in some markets. The company's extensive clinical research, regulatory approvals, and global distribution network position it as the primary supplier. Eli Lilly’s manufacturing facilities are certified under Good Manufacturing Practice (GMP) standards, ensuring high-quality production. Its supply chain benefits from established logistical infrastructure, enabling widespread availability across North America, Europe, and select Asia-Pacific markets[1].

Novel Biotech Firms and Biosimilar Manufacturers

The patent protection for Forteo expired in some jurisdictions around 2020-2022, opening opportunities for biosimilar manufacturers to enter the market. Several biotechnology companies have emerged as potential suppliers or developers of biosimilar teriparatide products:

• Biocon (India): As a major biosimilar producer, Biocon has announced plans to develop biosimilar versions of teriparatide. Its biosimilars are known for cost competitiveness and accessible manufacturing capabilities[2].

• mAbxience (Argentina): This biopharmaceutical firm focuses on biosimilar development, including osteoporosis drugs. While it has yet to register a teriparatide biosimilar, its R&D pipeline indicates potential future supplier status[3].

• Samsung BioLogics and Fujifilm Diosynth: These manufacturing giants are capable of producing biosimilar peptides and are investing in expanding their biosimilar portfolios, potentially including teriparatide biosimilars[4].

The biosimilar market aims to reduce drug costs and enhance accessibility, disrupting the traditional supply dominance of originator companies.

Contract Manufacturing Organizations (CMOs)

Contract manufacturing plays an essential role in scaling up teriparatide production, especially for biosimilars or new formulations. Leading CMOs involved in peptide and protein drug manufacturing include:

• Samsung Biologics: Offers end-to-end manufacturing, including fill-finish capabilities crucial for injectable therapies like teriparatide.

• Patheon (a part of Thermo Fisher Scientific): Provides peptide synthesis and formulation services, supporting biosimilar development.

• Yposkesi (France): Specializes in viral vectors and biologics manufacturing, with facilities capable of producing complex biologics at commercial scale[5].

CMOs provide flexible manufacturing solutions, helping mid-size biotech firms and generic companies to bring teriparatide biosimilars to market efficiently.

Supply Chain Challenges and Market Dynamics

Patent Expiry and Biosimilar Entry

The expiration of Eli Lilly’s patent rights created a wave of biosimilar development, fostering increased competition. Biosimilar entries typically result in price reductions, stimulating demand but also pressuring original manufacturers to innovate or diversify their product portfolios.

Regulatory Landscape

Biosimilar approval pathways differ globally, influencing supply timelines. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established rigorous biosimilar approval processes, impacting how quickly new suppliers can enter the market[6].

Manufacturing Complexity

Teriparatide's peptide nature necessitates complex manufacturing processes, including recombinant DNA technology and peptide purification. This technical complexity constrains the number of suppliers capable of producing pharmaceutical-grade teriparatide at scale.

Global Supply Security

The COVID-19 pandemic underscored vulnerabilities in global supply chains for biologics, including disrupted raw material access and manufacturing delays. Consequently, pharmaceutical companies are reassessing geographic diversification and investing in adaptable production platforms[7].

Emerging Trends in Teriparatide Supply

• Innovative Formulations: Companies explore alternative delivery mechanisms (e.g., longer-acting formulations or pens with improved stability) to expand market access.

• Digitalization and Supply Chain Transparency: Blockchain and digital tracking are implemented to enhance supply chain integrity.

• Strategic Alliances: Partnerships between originator firms and biosimilar developers accelerate time-to-market and ensure consistent supply.

• Manufacturing Capacity Expansion: Large-scale biologics facilities aim to meet increasing global demand, especially in emerging markets.

Regulatory and Market Considerations

The integration of biosimilars into the market facilitates broader access but raises concerns over supply reliability, substitution policies, and intellectual property rights. Policymakers are increasingly encouraging biosimilar uptake to reduce costs, which influences supplier diversification strategies[8].

Key Players Summary

Supplier	Product Name	Market Focus	Notes
Eli Lilly	Forteo, Vijoice	North America, Europe, Asia	Patent holder, global distribution network
Biocon	Biosimilar Teriparatide	India, emerging markets	Cost-competitive biosimilar development
mAbxience	Potential biosimilar	Latin America, global	Developing biosimilar pipeline
Samsung BioLogics, Fujifilm Diosynth	Contract manufacturing	Global	CMO for biosimilars and complex biologics

Conclusion

The landscape of teriparatide supply is dynamic, influenced heavily by patent expirations, biosimilar developments, and manufacturing advances. Eli Lilly remains the dominant supplier, with biosimilar entrants promising to shift pricing and accessibility. Contract manufacturers contribute significantly to capacity expansion, ensuring sustained supply continuity. Stakeholders must navigate regulatory complexities and technological challenges to optimize the global availability of this vital osteoporosis therapy.

Key Takeaways

• Market Leadership: Eli Lilly is the principal supplier of branded teriparatide, with extensive manufacturing and distribution channels.

• Biosimilar Potential: Expiry of patent protections has spurred biosimilar development in regions like India and Latin America, increasing competition and reducing costs.

• Manufacturing Challenges: Peptide biologics like teriparatide require sophisticated manufacturing processes, limiting the number of capable suppliers.

• Supply Chain Resilience: Diversification through biosimilars, CMOs, and geographic spread enhances supply security amid global disruptions.

• Regulatory Influence: Harmonized approval pathways accelerate biosimilar entry, impacting the overall supply landscape.

FAQs

1. Who are the main suppliers of teriparatide globally?
   Eli Lilly dominates the market with its Forteo brand. Biosimilar manufacturers such as Biocon, mAbxience, and others are entering the space as patents expire and biosimilar pathways mature.

2. What role do biosimilars play in the teriparatide supply chain?
   Biosimilars increase market competition, drive down prices, and improve access, especially in emerging markets. They are developed by specialized biotech firms and manufactured by CMOs.

3. What manufacturing challenges exist for producing teriparatide?
   The peptide’s complex recombinant production process demands high-precision manufacturing techniques, limiting the number of companies capable of producing high-quality biologic versions.

4. How might supply chain disruptions affect teriparatide availability?
   Global events like the COVID-19 pandemic can cause raw material shortages and manufacturing delays, underscoring the importance of diversified supply sources and strategic planning.

5. Are there regulatory hurdles for biosimilar teriparatide products?
   Yes. Biosimilars must demonstrate similarity in safety, efficacy, and quality, undergoing rigorous regulatory review processes that differ across regions.

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References

[1] Eli Lilly and Company. (2022). Forteo (teriparatide [rDNA origin]) intramuscular injection, full prescribing information.

[2] Biocon. (2021). Biocon announces development of biosimilar teriparatide. biotechnews.com.

[3] mAbxience. (2022). Pipeline overview and biosimilar initiatives. company website.

[4] Fiers, F., et al. (2021). Contract manufacturing of biologics: Trends, challenges, and opportunities. Pharmaceutical Manufacturing Journal.

[5] Yposkesi. (2022). Company overview and manufacturing capabilities. official website.

[6] European Medicines Agency. (2022). Biosimilar medicines: Overview and regulatory framework.

[7] WHO. (2020). Global supply chain disruptions in biologics during COVID-19.

[8] U.S. Food and Drug Administration. (2022). Biosimilar and interchangeable products.