Suppliers and packagers for TESTIM

TESTIM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454	NDA	Endo USA, Inc.	66887-001-05	30 TUBE in 1 CARTON (66887-001-05) / 5 g in 1 TUBE	2002-10-31

Suppliers for the Pharmaceutical Drug: Testim

Last updated: July 27, 2025

Introduction

Testim is a topical testosterone replacement therapy primarily prescribed for men diagnosed with testosterone deficiency or hypogonadism. Since its approval by the FDA in 2014, Testim has gained significant market presence, driven by a rising prevalence of testosterone deficiency among aging populations. The pharmaceutical supply chain supporting Testim involves a network of manufacturing entities, authorized distributors, and international suppliers. Understanding the landscape of suppliers for Testim is critical for stakeholders including healthcare providers, distributors, and regulatory bodies aiming to ensure product integrity, supply security, and compliance.

Manufacturers of Testim

1. Endo Pharmaceuticals Inc.
Endo Pharmaceuticals, a subsidiary of Endo International Plc, is the sole manufacturer of Testim in the United States. The company holds the manufacturing rights and is responsible for the formulation, production, and quality assurance processes. Endo acquired the rights to Testim from Auxilium Pharmaceuticals, which originally developed the product [1].

2. Auxilium Pharmaceuticals (Now Part of Endo)
Auxilium Pharmaceuticals developed Testim in conjunction with other hormone replacement therapies. Although Auxilium was acquired by Endo in 2015, its R&D and early manufacturing facilities contributed to establishing the initial test batch processes for Testim [2].

3. International Suppliers and Contract Manufacturers
While Endo is the primary manufacturer for the U.S. market, international suppliers may be involved in raw material supply or contract manufacturing for distribution in other regions, such as Europe or Asia. These include suppliers of testosterone esters or gel base components, often sourced from companies specializing in pharmaceutical-grade chemicals.

Raw Material Suppliers

Testim's efficacy and safety depend on high-quality raw materials, notably pharmaceutical-grade testosterone and excipients used in the gel formulation. These raw materials are typically procured from:

• Global Chemical Suppliers: Companies like BASF, Thermo Fisher Scientific, and BASF produce pharmaceutical-grade testosterone or the precursors used in testosterone synthesis.
• Excipients Suppliers: Firms providing gel base components, such as polymers, stabilizers, preservatives, and gelling agents, include Ashland Inc., Dow Chemical, and Croda International.

These raw materials must meet strict pharmacopeial standards, such as the USP or EP, to ensure product safety and efficacy.

Distribution Channels and Authorized Distributors

Following manufacturing, Testim is distributed through authorized pharmaceutical distributors who adhere to Good Distribution Practices (GDP). These companies serve as the link between manufacturers and pharmacies or clinics. Key distributors in the US include:

• McKesson Corporation
• Cardinal Health
• AmerisourceBergen

These wholesalers maintain the cold chain integrity when necessary and provide inventory management to meet patient needs.

Global Supply and International Markets

In markets outside the United States, local pharmaceutical companies may hold manufacturing and distribution rights. For example, in Europe, the product may be marketed under different brand names or formulations, with regional manufacturers or licensing partners acting as suppliers. The specific supplier landscape varies based on regional regulations and licensing agreements.

Regulatory and Supply Chain Considerations

• Regulatory Approval: Testim is FDA-approved; international approval depends on local agencies (EMA, MHRA, etc.). Suppliers must comply with Good Manufacturing Practice (GMP) standards to obtain and maintain approvals.
• Supply Chain Risks: Reliance on a limited number of raw material or manufacturing sources introduces supply chain risks. Disruptions in raw material procurement, manufacturing issues, or regulatory delays can impact product availability.
• Counterfeit Risks: Given high demand, counterfeit Testim products have emerged in illicit markets. Authenticity verification and secure supply channels are essential.

Key Providers in the Global Market

While Endo Pharmaceuticals is the primary supplier in the US, several international companies supply testosterone-based products broadly, such as:

• Bayer AG: Offers testosterone gels and patches as alternative products.
• Perrigo Company: Produces over-the-counter testosterone treatments in some markets.
• Lupin Pharmaceuticals: Manufactures generic testosterone products in India for export.

These companies, although not producing Testim under its specific brand, influence the broader testosterone gel market and supply raw materials or similar formulations.

Conclusion

The supply landscape for Testim centers around Endo Pharmaceuticals as the exclusive manufacturer for the U.S. market, supported by a network of raw material suppliers, contract manufacturers, and authorized distributors. Internationally, regional licensing and distribution agreements expand access but also introduce variability in sourcing. Ensuring product integrity involves rigorous adherence to GMP, supply chain security, and robust regulatory oversight.

Key Takeaways

• Endo Pharmaceuticals is the sole manufacturer of Testim in the US, controlling the entire supply chain process.
• Raw material sourcing involves reputable global suppliers of testosterone and excipients, with strict compliance to pharmacopeial standards.
• Distribution relies on large, regulated pharmaceutical wholesalers who ensure product integrity and availability.
• International markets often involve licensing agreements with regional manufacturers, increasing complexity in the supply chain.
• Supply chain vulnerabilities include raw material shortages, manufacturing disruptions, and risks of counterfeit products; robust verification and quality controls are vital.

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FAQs

1. Who are the main manufacturers of Testim globally?
Endo Pharmaceuticals is the primary manufacturer for the US market, with regional manufacturers handling distribution elsewhere depending on licensing agreements.

2. What raw materials are used in the formulation of Testim?
Testim is formulated using pharmaceutical-grade testosterone ester compounds and excipients such as gelling agents, stabilizers, and preservatives sourced from reputable chemical suppliers.

3. How do supply chain disruptions affect Testim availability?
Disruptions in raw material procurement, manufacturing issues, or regulatory delays can lead to shortages, impacting patients relying on testosterone therapy.

4. Are there alternative testosterone gel products supplied by other companies?
Yes, multiple companies, including Bayer and Perrigo, produce testosterone gels and patches, providing alternatives to Testim and broadening market options.

5. What measures are in place to prevent counterfeit Testim products?
Authorized distributors, serialization, tamper-evident packaging, and secure supply chain protocols are employed to ensure authenticity and prevent counterfeiting.

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Sources

1. Endo Pharmaceuticals. "Testim." [Official website], 2023.
2. Auxilium Pharmaceuticals. "History and Development of Testim," 2015.
3. U.S. Food and Drug Administration. "Testim Labeling and Approval Details," 2014.
4. Pharmaceutical chemical suppliers’ disclosures, BASF, Thermo Fisher Scientific, 2023.
5. Industry reports on hormone therapy distribution, IQVIA, 2022.