TESTOSTERONE ENANTHATE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eugia Pharma	TESTOSTERONE ENANTHATE	testosterone enanthate	INJECTABLE;INJECTION	212659	ANDA	Eugia US LLC	55150-336-01	1 VIAL, MULTI-DOSE in 1 CARTON (55150-336-01) / 5 mL in 1 VIAL, MULTI-DOSE	2024-02-28
Hikma Farmaceutica	TESTOSTERONE ENANTHATE	testosterone enanthate	INJECTABLE;INJECTION	091120	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9750-01	5 mL in 1 VIAL, MULTI-DOSE (0143-9750-01)	2012-09-18
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863	NDA	Antares Pharma, Inc.	54436-200-01	1 SYRINGE in 1 CARTON (54436-200-01) / .5 mL in 1 SYRINGE (54436-200-03)	2018-11-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Testosterone Enanthate is a long-acting injectable anabolic steroid widely used for testosterone replacement therapy (TRT) in men with hypogonadism, and occasionally prescribed for certain medical conditions such as delayed puberty or hormone imbalances. Its pharmacological efficacy, coupled with its manufacturing complexity, has fostered a dynamic supplier landscape ranging from large pharmaceutical companies to specialized compounding laboratories and chemical distributors.

This article offers a comprehensive overview of the primary suppliers for Testosterone Enanthate, including licensed pharmaceutical manufacturers, authorized distributors, and legitimate chemical suppliers. Insight into these sources aids healthcare providers, pharmacies, and regulated entities in navigating procurement, ensuring product safety, quality, and compliance.

Pharmaceutical Manufacturers of Testosterone Enanthate

1. Major Global Pharmaceutical Companies

Several major pharmaceutical firms are authorized producers of Testosterone Enanthate, owing to its approved therapeutic use. These manufacturers typically operate under stringent regulatory oversight from agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or equivalent bodies worldwide.

Bayer AG: Historically one of the largest producers of testosterone-based formulations, Bayer offers Testosterone Enanthate under strict regulatory standards. Their products are renowned for their quality assurance, adherence to Good Manufacturing Practices (GMP), and global distribution.
Watson Pharmaceuticals (now part of Teva Pharmaceuticals): Teva supplies Testosterone Enanthate in various markets, including the U.S. and Europe. Their manufacturing processes meet high-quality standards, ensuring consistency and safety.
Sandoz (Novartis Division): Sandoz produces testosterone injections, including Testosterone Enanthate, distributing through licensed healthcare providers and pharmacies.
Pfizer: While Pfizer’s focus has shifted, they have historically been a key global manufacturer under licensed approval.

2. Regional and Domestic Pharmaceutical Firms

Regional manufacturers in countries such as India, China, and Brazil have proliferated due to local demand for testosterone therapies and the absence of patent restrictions in certain regions.

Gandhi Clinicals (India): A significant supplier of generic testosterone products, including Testosterone Enanthate, primarily for domestic and nearby markets.
Hubei Yuancheng Pharmaceutical (China): Engaged in producing testosterone derivatives, including Testosterone Enanthate, for both domestic use and export.
Eurofarma (Brazil): A leading Latin American pharmaceutical company known for producing testosterone-based therapies, including Testosterone Enanthate.

Legal and Licensed Chemical Suppliers

1. Pharmaceutical Ingredient (API) Manufacturers

Chemical suppliers providing active pharmaceutical ingredients (APIs) critical for formulation are integral suppliers of Testosterone Enanthate. These suppliers often operate under rigorous quality standards and provide APIs to licensed pharmaceutical companies.

Hangzhou Zhongsheng Chemical Co., Ltd.: A notable API manufacturer with production capacity for Testosterone Enanthate. Their products are used by licensed pharmaceutical companies within regulatory frameworks.
Piramal Pharma Solutions: Offers high-purity APIs, including testosterone derivatives, for licensed formulations.
Huangpu Group (China): Supplies testosterone ester APIs for pharmaceutical use, with certifications adhering to GMP.

2. Chemical Distributors and Brokerage Firms

These entities supply Testosterone Enanthate raw material or finished products to licensed manufacturers and, in some jurisdictions, to authorized compounding pharmacies.

Xynergy Pharmaceuticals: Provides high-quality Testosterone Enanthate API for pharmaceutical manufacturing.
Bindotech: An API distributor based in India supplying testosterone esters to certified pharmaceutical manufacturers and research entities.

Note: Due to regulatory restrictions, these suppliers are primarily authorized for licensed entities within their jurisdictions and do not sell directly to the general public.

Compounding and Custom Synthesis Suppliers

While not manufacturers of registered pharmaceutical products, some licensed compounding pharmacies and custom synthesis laboratories produce Testosterone Enanthate based on licensed API sources. These entities operate within legal boundaries and adhere to strict quality controls.

Imprimis Pharmaceuticals: Offers compounded testosterone injections, including Testosterone Enanthate, for specific medical indications following prescribed formulations.
Specialized compounding labs in the USA and Europe sourcing API from certified manufacturers and adhering to local regulations.

Market Dynamics and Regulatory Considerations

The market for Testosterone Enanthate is heavily regulated in many jurisdictions, owing to its potential for misuse and abuse in sports pharmacology. Legitimate suppliers operate within a legal framework, mandated to meet strict quality and safety standards.

GMP Compliance: Regulatory agencies require GMP compliance for pharmaceutical manufacturing, ensuring product purity, potency, and safety.
Licensing and Certification: Only licensed pharmaceutical companies and authorized API suppliers can legally distribute Testosterone Enanthate for medical use.
Counterfeit Risks: Illicit suppliers and black-market vendors distribute counterfeit or substandard testosterone products, posing significant health risks.

Major Procurement Hurdles and Considerations

Legal Restrictions: Many countries regulate Testosterone Enanthate as a controlled substance, requiring proper licensing for purchase and distribution.
Product Authenticity: Buyers should verify supplier credentials, batch certification, and adherence to regulatory standards.
Supply Chain Integrity: Ensuring supply chain transparency minimizes risks of adulterated products.
Market Variability: Regional supply restrictions and patent protections influence product availability, often driving demand for imports or generics.

Conclusion

The procurement landscape for Testosterone Enanthate is diverse and highly regulated. Leading pharmaceutical manufacturers such as Bayer and Teva dominate the global market, providing high-quality, approved formulations. Regional pharmaceutical firms and specialized chemical suppliers serve local markets and research needs, often operating under stringent GMP standards. Careful due diligence, adherence to legal requirements, and verification of supplier credentials are essential to ensure access to safe and effective Testosterone Enanthate.

Key Takeaways

Major global pharmaceutical companies such as Bayer and Teva are primary licensed suppliers producing high-quality Testosterone Enanthate for therapeutic use.
Regional pharmaceutical firms in countries like India, China, and Brazil cater to local demand, often offering affordable alternatives.
Active Pharmaceutical Ingredient (API) manufacturers supply high-purity testosterone esters to licensed pharmaceutical companies for formulation.
Licensed compounding pharmacies may produce Testosterone Enanthate formulations while adhering to regional legal frameworks.
Regulatory compliance and verification are critical when sourcing Testosterone Enanthate to prevent counterfeit and substandard products.

FAQs

1. Is Testosterone Enanthate available over-the-counter?
No. It is a prescription-only medication in most jurisdictions due to its classification as a controlled substance with potential for misuse.

2. Can I purchase Testosterone Enanthate directly from API manufacturers?
Only licensed pharmaceutical companies or authorized API suppliers can sell Testosterone Enanthate API, and for legitimate pharmaceutical manufacturing purposes only.

3. What are the risks of buying from unregulated sources?
Counterfeit, contaminated, or substandard products pose significant health risks, including hormonal imbalance, infections, and other adverse effects.

4. Are all Testosterone Enanthate products equivalent regardless of supplier?
No. Differences in manufacturing standards can influence purity, potency, and safety. Always procure from reputable, licensed sources.

5. How do regulatory agencies ensure the safety of Testosterone Enanthate products?
Through strict manufacturing standards, GMP compliance, product testing, and post-market surveillance, agencies like the FDA and EMA govern product safety and efficacy.

References

[1] World Health Organization. (2019). International Nonproprietary Names for Pharmaceutical Substances.
[2] U.S. Food and Drug Administration. (2022). Approved Drugs Database.
[3] European Medicines Agency. (2023). Product Information on Testosterone Products.
[4] Drug Enforcement Agency. (2023). Controlled Substance Schedule.
[5] GlobalData. (2022). Global Testosterone Market Analysis.

Suppliers and packagers for generic pharmaceutical drug: TESTOSTERONE ENANTHATE