Suppliers and packagers for DEPO-TESTOSTERONE

DEPO-TESTOSTERONE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	DEPO-TESTOSTERONE	testosterone cypionate	INJECTABLE;INJECTION	085635	ANDA	Pharmacia & Upjohn Company LLC	0009-0085-10	1 VIAL in 1 CARTON (0009-0085-10) / 10 mL in 1 VIAL	2014-07-01
Pfizer	DEPO-TESTOSTERONE	testosterone cypionate	INJECTABLE;INJECTION	085635	ANDA	Pharmacia & Upjohn Company LLC	0009-0086-01	1 VIAL in 1 CARTON (0009-0086-01) / 1 mL in 1 VIAL	2014-07-01
Pfizer	DEPO-TESTOSTERONE	testosterone cypionate	INJECTABLE;INJECTION	085635	ANDA	Pharmacia & Upjohn Company LLC	0009-0347-02	1 VIAL in 1 CARTON (0009-0347-02) / 10 mL in 1 VIAL	1979-07-25

Last updated: August 1, 2025

ppliers for the Pharmaceutical Drug: DEPO-TESTOSTERONE

Introduction
Depo-Testosterone, a well-known brand of intramuscular testosterone ester, primarily contains testosterone enanthate. It is used in hormone replacement therapy (HRT) and for other medical conditions that require testosterone supplementation. As a controlled substance, its manufacturing and distribution are tightly regulated. This article offers a comprehensive overview of suppliers involved in the production and distribution of Depo-Testosterone, focusing on licensed manufacturers, authorized distributors, and the global supply landscape essential for stakeholders aiming to secure a reliable supply chain or understand market dynamics.

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1. Origin and Global Manufacturing of Depo-Testosterone

Depo-Testosterone is produced by major pharmaceutical companies specializing in hormone therapies. It is generally manufactured by companies approved by health authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and similar regulatory agencies worldwide. The active pharmaceutical ingredient (API), testosterone enanthate, forms the core of this medication, sourced from high-quality chemical suppliers that meet strict Good Manufacturing Practice (GMP) standards.

2. Primary Manufacturers of Depo-Testosterone

a. Pfizer Inc.
Pfizer holds the original rights to Depo-Testosterone and has been a dominant supplier globally. The company manufactures and markets Depo-Testosterone under strict regulatory compliance across numerous countries. Pfizer's manufacturing facilities adhere to international GMP standards, ensuring product integrity and quality. Pfizer remains the primary licensed supplier within most markets, especially in North America and Europe.

b. Other Licensed Manufacturers
In certain regions, licensing agreements or generic manufacturers produce testosterone enanthate equivalent formulations, which may be marketed under different brand names or as unbranded generics. These manufacturers often source testosterone enanthate API from accredited chemical suppliers and follow local regulatory procedures to register their products.

3. API Suppliers for Testosterone Enanthate

The core of Depo-Testosterone, testosterone enanthate, is synthesized by specialized chemical producers. Leading API suppliers include:

• BASF
  A prominent global chemical company providing raw materials for pharmaceutical synthesis, including testosterone esters.
• Lonza
  A Swiss-based contract manufacturer supplying high-grade hormone APIs to pharmaceutical companies.
• Bachem
  Known for producing specialized peptides and small molecules, including testosterone-related compounds.
• Ajinomoto Bio-Pharma Services
  Provides GMP-grade APIs for hormone-based medications, including testosterone esters.

These suppliers focus on high-purity, batch-consistent APIs compliant with pharmacopeial standards.

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4. Authorized Distributors and Market Access

Pharmaceutical companies and licensed wholesalers handle distribution within regulated markets. This network includes:

a. Large Global Distributors

• McKesson
• AmerisourceBergen
• Cardinal Health

These entities supply licensed pharmacies and hospitals with Depo-Testosterone, ensuring procurement aligns with legal and safety standards.

b. Regional Distributors
Regional pharmaceutical distributors broker the supply chain within specific markets, often authorized by Pfizer or licensed generic manufacturers. They ensure distribution complies with local regulatory controls, licensing, and storage requirements for controlled substances.

5. Generic and Biosimilar Market

The patent for Depo-Testosterone expired in many jurisdictions, opening markets for generic testosterone enanthate products. These are produced by licensed biosimilar manufacturers, such as:

• Sandoz (Novartis)
• Ming Fai (China)
• Sun Pharmaceutical Industries Ltd.

While these products may not carry the Depo-Testosterone brand, they are approved for similar indications and contain identical active ingredients, subject to bioequivalence studies and regulatory approval.

6. Regulatory and Supply Chain Considerations

Due to the controlled nature of testosterone and related products, supply chains are subject to stringent regulation. Suppliers must comply with:

• GMP standards
• Controlled substance licensing
• Traceability and batch tracking

Disruptions in supply often stem from regulatory changes, geopolitical factors, or manufacturing issues, emphasizing the importance of engaging with reputable, licensed suppliers.

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7. Market Dynamics and Trends

The demand for Depo-Testosterone continues to grow, driven by increasing awareness of testosterone deficiency and expanding indications. However, supply constraints sometimes occur due to regulatory crackdowns or shortages of raw materials. Companies investing in API production capacity or alternative sourcing channels are strategically positioned to meet market needs.

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Key Takeaways

• Pfizer remains the primary licensed manufacturer and supplier of Depo-Testosterone globally, with authorized distributors ensuring market reach.
• High-quality testosterone enanthate API providers, such as BASF and Lonza, serve as the backbone of licensed Depo-Testosterone production.
• Generic manufacturers have filled market gaps post-patent expiry, providing cost-effective alternatives under regulatory approval.
• The supply of Depo-Testosterone is highly regulated, with strict adherence to GMP and controlled substance laws critical for stable availability.
• Market growth is tempered by supply chain complexities and regulatory environments; proactive engagement with reputable suppliers ensures continuity.

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FAQs

Q1: Is Depo-Testosterone available from multiple suppliers globally?
A1: Yes, while Pfizer remains the primary licensed producer, generic companies and biosimilar manufacturers also supply testosterone enanthate, expanding options in various markets.

Q2: How can I verify if a supplier is authorized to produce Depo-Testosterone?
A2: Confirm sourcing through official regulatory registration, licensing documentation, and GMP compliance certifications provided by authorities such as the FDA or EMA.

Q3: Are there risks associated with unlicensed or counterfeit testosterone products?
A3: Yes, unlicensed products pose significant safety and efficacy risks. Always procure from validated, licensed sources to ensure product integrity.

Q4: What are the main factors influencing the supply stability of Depo-Testosterone?
A4: Regulatory changes, raw material availability, manufacturing capacity, and geopolitical issues are critical factors affecting supply stability.

Q5: Can I negotiate directly with API suppliers to ensure better pricing or supply terms?
A5: Only licensed pharmaceutical companies or authorized intermediaries can engage directly with API suppliers, and such negotiations typically occur within regulated channels.

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References

[1] Pfizer Inc. Product information and licensing details.
[2] European Medicines Agency. Guidelines on testosterone formulations.
[3] BASF. API production standards for testosterone esters.
[4] Lonza Group AG. API manufacturing processes for hormone products.
[5] Global pharmaceutical market reports on testosterone and hormone therapies.