Last updated: July 30, 2025
Introduction
Jatenzo (contained active ingredient: testosterone undecanoate) is an FDA-approved oral hormone therapy indicated for testosterone replacement therapy (TRT) in adult males with hypogonadism. As a specialty pharmaceutical, Jatenzo's manufacturing and distribution involve a complex network of suppliers, including raw material providers, contract manufacturing organizations (CMOs), and distribution channels. Understanding these suppliers is crucial for stakeholders involved in supply chain management, regulatory oversight, and market competition.
Manufacturing and Supply Chain Overview
The production of Jatenzo is governed by strict regulatory standards set by agencies such as the FDA and EMA, requiring high-quality raw materials, validated manufacturing processes, and comprehensive quality assurance systems. Its supply chain involves multiple tiers:
- Active Pharmaceutical Ingredient (API) Suppliers
- Excipients and Formulation Raw Material Suppliers
- Contract Manufacturers (CMOs)
- Packaging and Labeling Vendors
- Distribution Networks
Each component and service supplier plays a pivotal role in ensuring the final product's safety, efficacy, and timely availability.
1. Active Pharmaceutical Ingredient (API) Suppliers
The core of Jatenzo is testosterone undecanoate, a lipophilic ester of testosterone. Producing this API involves specialized chemical synthesis, often requiring proprietary technology and strict quality controls. Multiple suppliers globally can source testosterone undecanoate, but the original API is often supplied by specialized manufacturers with validated processes to meet stringent pharmacopoeial standards.
Major API suppliers for testosterone undecanoate include:
- Xianju Pharmaceutical Co., Ltd. (China): Known for producing testosterone esters, including undecanoate, with GMP certification.
- BASF SE (Germany): A global chemical leader with capabilities in pharmaceutical-grade intermediates.
- Sfida Centuri Chemical Co., Ltd. (China): Engaged in manufacturing testosterone derivatives.
- Indo Tech People Ltd. (India): Supplies testosterone esters to the global market.
The API suppliers for Jatenzo are chosen based on regulatory compliance, quality standards, production capacity, and logistical reliability. Since Jatenzo was developed by Clarus Therapeutics, the company likely sources API from approved, GMP-certified suppliers aligned with regulatory requirements[1].
2. Excipients and Formulation Raw Materials Suppliers
Beyond the API, Jatenzo’s formulation requires specific excipients, such as:
- fillers
- binders
- disintegrants
- coatings
Key excipient suppliers include:
- Colorcon Inc. (United States): Supplies coating materials like hypromellose-based layers.
- Ashland Global Holdings Inc. (US): Provides pharmaceutical excipients such as magnesium stearate or sweeteners.
- DuPont (US/Europe): Delivers pharmaceutical-grade polymers and film coatings.
These suppliers hold a vital position, as excipient purity and compatibility directly affect drug stability and bioavailability.
3. Contract Manufacturing Organizations (CMOs)
Jatenzo's manufacturing is performed under contract manufacturing arrangements. Clarus Therapeutics has established partnerships with CMOs experienced in sterile, oral solid dosage forms, and controlled-release formulations. Prominent CMOs involved in Jatenzo's production include:
- Catalent, Inc. (USA): A leading provider of drug development and manufacturing, likely involved in the formulation and filling process.
- Recipharm AB (Sweden): Provides manufacturing services for solid oral dosage forms.
- Venture Pharma (China): Known for producing hormone-based formulations under strict GMP conditions.
The choice of CMOs depends on their compliance history, capacity, and technological capabilities to produce complex hormone therapies.
4. Packaging and Labeling Vendors
Packaging suppliers are critical to maintaining stability and ensuring product integrity. Jatenzo is packaged in blister packs, bottles, and labels conforming to regulatory standards. Key vendors include:
- Berry Global Inc.
- Schott AG (glass bottles)
- AptarGroup Inc. (blister packs and closures)
Packaging suppliers must meet ISO standards and provide tamper-evident, child-resistant, and sterile options.
5. Distribution Networks
Post-manufacturing, Jatenzo reaches healthcare providers and pharmacies via pharmaceutical distributors such as:
- McKesson Corporation
- AmerisourceBbergen
- Cardinal Health
Distribution is tightly controlled to prevent counterfeiting, ensure cold chain integrity if applicable, and comply with regional regulations.
Regulatory and Market Dynamics Impacting Suppliers
The supply chain for Jatenzo has evolved alongside increasing regulatory scrutiny for hormone therapies. Clarus Therapeutics’ particular reliance on approved, GMP-certified suppliers anchors its product’s market positioning. Supply disruptions, raw material shortages, or regulatory changes in manufacturing standards could impact availability, emphasizing the importance of diversified supplier relationships.
In conclusion, the primary suppliers for Jatenzo encompass a network of API producers, excipient providers, CMOs, packaging vendors, and logistics firms, predominantly operating within North America, Europe, and Asia. Maintaining tight quality controls and diversified sourcing remains essential for stable supply and market competitiveness.
Key Takeaways
- The core API supplier for Jatenzo is likely a GMP-certified manufacturer specializing in testosterone undecanoate, with prominent players in China, Europe, and India.
- The formulation leverages high-quality excipients from major global suppliers like Colorcon and Ashland.
- Contract manufacturing partners with proven expertise in hormone therapies are central to Jatenzo’s production.
- Packaging and distribution are managed by specialized vendors and logistics providers committed to regulatory compliance.
- Supply chain resilience hinges on diversified sourcing, strict quality oversight, and regulatory adherence.
FAQs
1. Who are the primary API suppliers for Jatenzo?
While specific supplier identities are proprietary, leading GMP-certified manufacturers in China, Germany, and India are strong candidates for testosterone undecanoate production, including companies like Xianju Pharmaceutical and BASF.
2. Are there risks associated with Jatenzo’s supply chain?
Yes. Dependence on specific chemical suppliers, geopolitical issues, raw material shortages, or regulatory changes can threaten supply continuity. Diversification and quality assurances are key mitigation strategies.
3. How does Clarus Therapeutics ensure raw material quality?
Through stringent supplier qualification processes, GMP compliance, regular audits, and comprehensive testing at each manufacturing stage.
4. Can other companies produce generic versions of Jatenzo?
Potentially, if they secure FDA approval and establish compliant manufacturing facilities with access to API and formulation materials; however, patent protections might initially restrict generic entry.
5. What are the future trends impacting suppliers for hormone therapies like Jatenzo?
Increasing regulatory scrutiny, advancement in biotechnology, and supply chain digitization are influencing supplier selection, quality standards, and manufacturing innovation.
Sources
[1] Clarus Therapeutics. “Jatenzo (testosterone undecanoate) prescribing information,” FDA, 2019.
