Suppliers and packagers for trelstar

trelstar

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715	NDA	Verity Pharmaceuticals Inc.	74676-5902-1	1 KIT in 1 CARTON (74676-5902-1) * 2 mL in 1 VIAL, SINGLE-DOSE (74676-5902-0) * 2 mL in 1 SYRINGE	2000-06-15
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288	NDA	Verity Pharmaceuticals Inc.	74676-5904-1	1 KIT in 1 CARTON (74676-5904-1) * 2 mL in 1 VIAL, SINGLE-DOSE (74676-5904-0) * 2 mL in 1 SYRINGE	2001-06-29
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	022437	NDA	Verity Pharmaceuticals Inc.	74676-5906-1	1 KIT in 1 CARTON (74676-5906-1) * 2 mL in 1 VIAL, SINGLE-DOSE (74676-5906-0) * 2 mL in 1 SYRINGE	2010-03-11

Suppliers for the Pharmaceutical Drug: Trelstar

Last updated: August 2, 2025

Introduction

Trelstar (triptorelin pamoate) is a long-acting gonadotropin-releasing hormone (GnRH) agonist primarily used in the treatment of prostate cancer, endometriosis, and uterine fibroids. As an essential therapeutic agent, the drug’s supply chain is critical for ensuring universal patient access. This analysis provides a comprehensive overview of current suppliers for Trelstar, examination of manufacturing dynamics, and implications for stakeholders from a industry perspective.

Overview of Trelstar and Its Market

Trelstar, marketed by Ferring Pharmaceuticals, is a branded formulation of triptorelin. Since its market approval, it has faced competition from generic formulations, regulatory changes, and evolving patent landscapes (e.g., patent expirations have historically prompted entrants to develop biosimilar or generic counterparts). The global demand for hormonally targeted therapies like Trelstar is driven significantly by prostate cancer prevalence, which is anticipated to grow with increasing aging populations worldwide [1].

Primary Manufacturer and Marketed Formulation

Ferring Pharmaceuticals retains the patent and manufacturing rights to Trelstar in multiple regions, with the medication available in various formulations such as intramuscular injections. The company’s manufacturing facilities, primarily based in Europe, produce the active pharmaceutical ingredient (API) and finished products. Ferring’s control over the drug’s supply chain positions it as the dominant supplier in the branded segment.

Current Suppliers of Trelstar

1. Ferring Pharmaceuticals

As the originator, Ferring is the principal supplier of Trelstar. They manage a vertically integrated supply chain encompassing API synthesis, formulation, packaging, and regulatory compliance. Ferring's manufacturing facilities are inspected and certified by major regulatory agencies, including the FDA and EMA, ensuring consistent product quality. Their extensive distribution network supports global availability, covering North America, Europe, Asia, and other regions.

2. API Suppliers for Triptorelin

The manufacturing of Trelstar’s API involves complex chemical synthesis, often requiring high-purity starting materials and advanced production techniques. Several international API producers supply triptorelin to Ferring or other generic manufacturers under licensing agreements. These API suppliers are primarily based in India, China, and Europe. Notable among them:

• Sun Pharma (India): A major API producer with a portfolio encompassing hormonal APIs, including triptorelin. They adhere strictly to Good Manufacturing Practices (GMP), with facilities certified by regulatory agencies [2].

• Honest Chem (India): Engaged in API manufacturing for hormonal peptides, including triptorelin, with export accreditation to global markets.

• WuXi AppTec (China): Provides both API synthesis and contract manufacturing services, with capabilities in peptide APIs.

• Cobra Biomanufacturing (India): Specializes in sterile peptide APIs and biologics, and supplies triptorelin for various formulations.

3. Generic Manufacturers and Contract Manufacturers

As patent protections for Trelstar have expired or are nearing expiration in key jurisdictions, multiple generic manufacturers have begun producing triptorelin-based formulations. These include:

• Sandoz (Novartis): Offers generic triptorelin in various markets, often supplied to compounding pharmacies or as part of biosimilar portfolios.

• Biocon (India): Developing biosimilars and generic peptides, including triptorelin, expanding global access.

• Amneal Pharmaceuticals: Recently entered the peptide generics market with triptorelin formulations.

Contract manufacturing organizations (CMOs) are also active in producing Trelstar's finished formulations under licensing or white-label agreements, facilitating supply chain flexibility.

Regulatory and Supply Chain Dynamics

The supply of Trelstar depends heavily on the regulatory status of its API and formulations. Regulatory approvals impact manufacturing decisions and supply stability.

• GMP Certification and Quality Control: Suppliers must meet strict standards imposed by agencies like the FDA, EMA, and PMDA. Disruptions in certification can lead to supply shortages.

• Patent Status and Market Entry: The expiration of key patents has spurred a proliferation of generics, increasing competition but also complicating supply chain management, as multiple manufacturers enter markets with variable quality standards.

• COVID-19 Pandemic Impact: Disruptions caused by the pandemic have affected supply chain logistics, affecting API sourcing and manufacturing timelines.

Market Challenges and Opportunities

While Ferring remains the primary supplier of branded Trelstar, market expansion into emerging economies presents opportunities for generic suppliers. However, quality assurance, regulatory compliance, and intellectual property considerations remain critical hurdles for new entrants.

The trend toward biosimilars and peptide generics suggests an evolving landscape, with increased competition poised to influence prices, supply stability, and access.

Key Takeaways

• Ferring Pharmaceuticals dominates the supply of Trelstar globally, controlling the branded product and some API manufacturing.
• Indian and Chinese API producers are critical suppliers of triptorelin, serving both branded and generic markets.
• The expiration of patents has led to increased generic manufacturing, diversifying supply sources but raising quality and regulatory vigilance.
• Supply chain resilience is vital given recent disruptions from global events, requiring robust quality assurance processes among suppliers.
• The growth in emerging markets offers expansion opportunities for generic producers, provided regulatory standards are met.

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Conclusion

The supply landscape of Trelstar is characterized by a combination of proprietary manufacturing controlled by Ferring and a rapidly expanding generic ecosystem driven by API suppliers from India and China. Navigating this environment requires careful attention to regulatory compliance, quality assurance, and geopolitical factors influencing global manufacturing and distribution.

Key Takeaways

• Major supplier dominance by Ferring ensures reliable access but limits price competition.
• API sourcing from India and China provides cost advantages but necessitates rigorous quality oversight.
• Patent expirations have facilitated market entry for generics, expanding supply diversity.
• Manufacturing disruptions remain a key risk, highlighting the importance of supply chain resilience.
• Emerging markets present growth opportunities, contingent upon regulatory and quality standards.

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FAQs

1. Who are the primary suppliers of triptorelin API used in Trelstar?
Indian companies such as Sun Pharma and Honest Chem, alongside Chinese manufacturers like WuXi AppTec, are prominent API suppliers supplying triptorelin to both branded and generic pharmaceutical manufacturers.

2. How does patent expiration influence the supply of Trelstar?
Patent expiration enables generic manufacturers to produce triptorelin formulations, increasing supply options, driving competition, and potentially reducing prices but also introducing variability in quality.

3. Are there supply chain risks associated with API sourcing from China and India?
Yes. While cost-effective, reliance on API suppliers from these regions entails risks related to regulatory compliance, geopolitical tensions, and supply disruptions caused by global events like the COVID-19 pandemic.

4. How do regulatory standards impact the quality and availability of Trelstar?
Strict adherence to GMP and regulatory approvals from agencies like the FDA and EMA are essential for API suppliers and manufacturers to ensure product quality, safety, and consistent supply.

5. What is the future outlook for Trelstar suppliers?
With increasing generic entrants and growing global demand, suppliers who maintain quality compliance and supply chain agility will be well-positioned to meet evolving market needs.

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References

[1] World Health Organization. Cancer Fact Sheets. 2022.
[2] Sun Pharma. API Manufacturing Capabilities. 2023.