Bulk Pharmaceutical API Sources for JATENZO

Bulk Pharmaceutical API Sources for JATENZO

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		65157
ABI Chem		AC1L22PV
ChemMol		49406046
AKos Consulting & Solutions		AKOS016010255

Bulk Active Pharmaceutical Ingredient (API) Sources for JATENZO

Last updated: July 28, 2025

Introduction

JATENZO (testosterone undecanoate) is an oral testosterone formulation approved by the U.S. Food and Drug Administration (FDA) primarily used to treat testosterone deficiency in adult males. As a key component, the Active Pharmaceutical Ingredient (API)—testosterone undecanoate—is fundamental to JATENZO’s efficacy and safety profile. The supply chain of the API involves multiple players, including API manufacturers, reputable intermediaries, and contract manufacturing organizations (CMOs). Ensuring access to high-quality, compliant API sources is critical for pharmaceutical firms seeking to produce, market, or distribute JATENZO globally. This report provides a comprehensive overview of bulk API sources for testosterone undecanoate relevant to JATENZO, emphasizing regulatory compliance, sourcing strategies, and market dynamics.

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Overview of Testosterone Undecanoate as API

Testosterone undecanoate is a lipophilic esterified form of testosterone designed for improved bioavailability when administered orally. It is synthesized via esterification processes involving testosterone and undecanoic acid, with subsequent purification essential to meet pharmaceutical quality standards such as those outlined by the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and other regional regulators. The API’s purity, stability, and batch-to-batch consistency directly influence the performance of the finished drug product.

The API market for testosterone undecanoate caters primarily to regulated pharmaceutical companies but also includes several unregulated and semi-regulated suppliers. Due diligence in sourcing is paramount to ensure regulatory compliance, especially considering doping regulations and strict manufacturing guidelines.

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Key API Manufacturers for Testosterone Undecanoate

1. Strides Pharma Science Ltd.

Overview: Strides is an Indian pharmaceutical manufacturer with a significant presence in the hormonal API segment, specializing in testosterone esters, including testosterone undecanoate.

Capabilities: Strides produces pharmaceutical-grade testosterone undecanoate compliant with international standards (e.g., cGMP, ISO). Their API manufacturing facilities are approved by regulatory agencies such as the U.S. FDA, EMA, and WHO.

Market Position: As a leading supplier in Asia, Strides’ API is exported globally, including to North America, Europe, and emerging markets, with certifications ensuring quality assurance.

2. Shanghai Fosun Pharmaceutical (Group) Co., Ltd.

Overview: Fosun is a prominent Chinese pharmaceutical conglomerate with extensive capacity in steroid hormone APIs.

Capabilities: The company manufactures testosterone esters, including undecanoate, with an emphasis on quality control aligned with international standards. Fosun’s manufacturing facilities adhere to GMP, and their API products are licensed for global export.

Market Position: Fosun’s broad portfolio and aggressive expansion into the global API market positions it as a considerable player for testosterone undecanoate supply.

3. ACG Worldwide

Overview: An Indian-based API and intermediates manufacturer with a diversified portfolio in steroid hormones.

Capabilities: ACG offers testosterone undecanoate APIs, emphasizing high purity, reproducibility, and large-scale manufacturing. Their facilities are certified by USFDA, EU-GMP, and other regulatory bodies.

Market Position: ACG supplies bulk API to global pharmaceutical companies, including generic and branded drug makers. Their supply chain supports reliable, large-volume API production.

4. Hubei Yuanchen Pharmaceutical Co., Ltd.

Overview: Chinese pharmaceutical manufacturer focusing on steroid hormones and intermediates.

Capabilities: Yuanchen produces testosterone undecanoate API compliant with cGMP standards and exports primarily to Asian markets but increasingly to European and North American counterparts.

Market Position: While not as globally recognized as larger firms, Yuanchen has demonstrated consistent quality performance and competitive pricing.

5. Generic API Producers and Contract Manufacturers

In addition to active branded manufacturers, several contract manufacturing organizations (CMOs) offer testosterone undecanoate APIs through toll manufacturing, including:

• Lonza (Switzerland): Known for high-quality APIs, including testosterone derivatives.

• Thermo Fisher Scientific: Provides custom synthesis and manufacturing services, including steroid APIs.

• BASF: Produces pharmaceutical intermediates, including steroid hormone APIs.

6. Emerging Markets and Smaller Suppliers

Smaller and mid-sized suppliers in India, China, and Eastern Europe offer Testosterone undecanoate APIs, often at more competitive prices. However, due diligence regarding compliance with cGMP or equivalent standards, audit reports, and certifications is necessary to mitigate regulatory and quality risks.

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Regulatory and Quality Considerations in API Sourcing

The selection of an API supplier must prioritize regulatory compliance, including adherence to cGMP, rigorous quality testing (e.g., HPLC purity, residual solvents, heavy metals), and certified manufacturing practices. Suppliers with approvals from the FDA, EMA, WHO, or comparable authorities typically provide higher assurance levels.

International sourcing necessitates comprehensive supplier audits, batch consistency verification, and stability testing data to ensure API suitability for finished drug formulation.

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Market Dynamics and Future Trends

Supply Chain Risks

The global API market faces risks such as geopolitical tensions, trade restrictions, and supply chain disruptions—particularly relevant amid recent pandemic-related challenges. Diversification of suppliers across regions mitigates risks and ensures continuous supply for JATENZO production.

Pricing and Competition

Pricing pressures, especially from Indian and Chinese manufacturers, influence procurement strategies. While competitive pricing is advantageous, concerns over intellectual property rights, regulatory acceptance, and quality assurance often limit reliance on smaller or unverified suppliers.

Regulatory Shifts

Global regulatory agencies increasingly scrutinize API manufacturing facilities, mandating transparency and comprehensive documentation. Companies seeking to produce JATENZO must ensure API sources comply with evolving standards, including serialization, traceability, and validation processes.

Innovation and New Technologies

Advancements in synthetic chemistry, process intensification, and continuous manufacturing are expected to improve API quality, yield, and environmental sustainability. Suppliers investing in such technologies will likely grow in prominence.

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Conclusion

The sourcing of high-quality testosterone undecanoate API is integral to the production of JATENZO. Leading global manufacturers—such as Strides Pharma, Fosun Pharma, ACG Worldwide, and Yuanchen—offer reliable, compliant APIs capable of supporting large-scale pharmaceutical manufacturing. Established regulatory compliance, robust quality systems, and supply chain stability are critical factors when selecting API suppliers.

As the geopolitical landscape and regulatory standards evolve, pharmaceutical companies should diversify their supplier bases, conduct thorough due diligence, and foster strategic alliances with established, compliant API manufacturers.

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Key Takeaways

• Top API suppliers include Strides Pharma, Fosun Pharma, ACG Worldwide, and Yuanchen, each offering GMP-compliant testosterone undecanoate API suitable for JATENZO production.
• Regulatory compliance and quality assurance must guide API sourcing to mitigate risks of contamination, variability, or regulatory rejection.
• Diversification of API sources reduces supply chain vulnerabilities, especially amid geopolitical or logistical disruptions.
• Emerging suppliers can offer competitive pricing but require comprehensive validation, certification, and audit verification.
• Market trends highlight increased scrutiny on manufacturing standards, pushing suppliers to enhance technological capabilities and transparency.

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FAQs

1. What are the primary regions supplying testosterone undecanoate API for use in JATENZO?
India and China are the leading regions producing testosterone undecanoate API due to their established infrastructure and cost advantages. European and North American suppliers tend to focus on higher regulatory standards, often through CMOs or licensed manufacturers.

2. How can pharmaceutical companies verify the quality of API suppliers?
Verification involves reviewing supplier certifications (cGMP, ISO), performing audit inspections, analyzing batch testing reports, and confirming compliance with regional regulatory standards (FDA, EMA, WHO).

3. What risks are associated with sourcing testosterone undecanoate API from unverified suppliers?
Risks include contamination, inconsistent potency, regulatory non-compliance, intellectual property violations, and potential product recalls, which could compromise patient safety and company's market authorization.

4. Are there regional differences in API quality standards?
Yes. While globally recognized agencies like the FDA and EMA impose strict standards, some suppliers in emerging markets may have variable quality controls. Companies should require thorough documentation and validation regardless of supplier location.

5. What are the future trends influencing API sourcing for hormonal drugs like JATENZO?
Future trends include increased adoption of continuous manufacturing, stricter regulatory oversight, emphasis on supply chain transparency, and technological innovations to improve quality, traceability, and environmental sustainability.

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Sources:

1. FDA Drug Approval Archives – JATENZO
2. Pharmaceutical Technology – Testosterone API Market Insights
3. Global Industry Analysts – API Market Outlook
4. WHO Global Database on Steroid APIs
5. [Supplier Websites and Regulatory Filings (as publicly available)]