Last Updated: May 21, 2026

Suppliers and packagers for depo-testosterone


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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
Pfizer DEPO-TESTOSTERONE testosterone cypionate INJECTABLE;INJECTION 085635 ANDA Pharmacia & Upjohn Company LLC 0009-0417-01 1 VIAL in 1 CARTON (0009-0417-01) / 1 mL in 1 VIAL 1979-07-25
Pfizer DEPO-TESTOSTERONE testosterone cypionate INJECTABLE;INJECTION 085635 ANDA Pharmacia & Upjohn Company LLC 0009-0417-02 1 VIAL in 1 CARTON (0009-0417-02) / 10 mL in 1 VIAL 1979-07-25
Pfizer DEPO-TESTOSTERONE testosterone cypionate INJECTABLE;INJECTION 085635 ANDA Hospira, Inc. 0409-6557-01 1 VIAL in 1 CARTON (0409-6557-01) / 10 mL in 1 VIAL 2016-08-01
Pfizer DEPO-TESTOSTERONE testosterone cypionate INJECTABLE;INJECTION 085635 ANDA Hospira, Inc. 0409-6562-01 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL 2016-08-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: Depo-Testosterone

Last updated: February 20, 2026

Who are the primary manufacturers of Depo-Testosterone?

Depo-Testosterone (testosterone enanthate) is a synthetic form of testosterone used primarily for hormone replacement therapy. The drug is available through multiple suppliers globally, either as branded or generic formulations. Major manufacturers include:

  • AbbVie Inc. (formerly Endo Pharmaceuticals): Produces Depo-Testosterone under the brand name Depo-Testosterone. It is an authorized generic through various distribution channels.
  • Perrigo Company: Sells generic versions of testosterone enanthate in multiple markets.
  • Ferring Pharmaceuticals: Manufactures testosterone enanthate under different brand names, primarily for European and international markets.
  • Watson Pharmaceuticals (now part of Allergan): Previously supplied generic testosterone enanthate.
  • Euromedica: Supplies testosterone enanthate in several Central European countries.

Key Market Specifications

Supplier Product Name Formulation Strength Regions Served Regulatory Status
AbbVie Inc. Depo-Testosterone Injectable Solution 100 mg/mL (1 mL vial) North America, some international FDA approved, EMA approved
Perrigo Company Testosterone Enanthate Injectable 200 mg/mL (vial) North America, Europe, Australia FDA, MHRA, TGA approvals
Ferring Pharmaceuticals Testogan, Zyczad Injectable 250 mg/mL Europe, Middle East EMA approval
Euromedica Testosterone Enanthate Injectable 200 mg/mL Central Europe Local regulatory approval

Distribution Channels & Supply Dynamics

  • Branded products: Primarily supplied by Pfizer (Depo-Testosterone), which oversees manufacturing and marketing under a licensing agreement. Pfizer's withdrawal from the US market led to a surge in generic imports.
  • Generic products: Manufactured by various regional pharmaceutical companies, often produced in India, China, and Eastern Europe.
  • Importation: Some markets depend heavily on imports due to local manufacturing limitations or patent expirations.
  • Online Suppliers and Distributors: In regions with limited access, some suppliers distribute through online channels. Risks include variability in quality and authenticity.

Regulatory and Patent Landscape

  • Patent expiry: Since the original patent expired decades ago, multiple generics are available.
  • Regulatory approval: US Food and Drug Administration (FDA) approved generics exist, with some marketed as bioequivalent. European Medicines Agency (EMA) approval licenses multiple formulations.
  • Import restrictions: Some countries impose strict import controls or require special licensing for testosterone products.

Key Considerations for Procurement

  • Quality assurance: Verify supplier credentials, regulatory approvals, and Good Manufacturing Practices (GMP) compliance.
  • Pricing: Generic versions significantly reduce costs compared to branded Depo-Testosterone.
  • Supply stability: Evaluate supplier capacity, inventory levels, and geopolitical risks affecting manufacturing sites.
  • Legal compliance: Ensure adherence to laws regulating controlled substances, such as testosterone, which is classified as a Schedule III drug under US law.

Potential Suppliers and Market Entry Points

  • Existing licensed suppliers include Pfizer, Perrigo, Ferring, and Euromedica.
  • Contract manufacturers can produce formulations under third-party licensing.
  • Emerging markets see increasing entry from Indian companies such as Sun Pharmaceutical Industries and Cadila Healthcare.

Summary

Depo-Testosterone's global supply hinges on a limited pool of manufacturers. While Pfizer remains the primary branded supplier in some regions, the majority of the market relies on generic producers, especially in Asia and Europe. The product's patent expiration, regional approval processes, and importation barriers shape the competitive landscape.


Key Takeaways

  • Several major pharmaceutical firms produce testosterone enanthate, directly competing in generic markets.
  • The drug's status as a controlled substance imposes strict regulatory and importation controls.
  • Price variations are significant between branded and generic options, with generics dominating the market.
  • Distribution channels include traditional wholesalers, regional distributors, and online suppliers, each with different quality and security implications.
  • Regulatory approval and manufacturing standards are critical for market entry and ongoing supply stability.

FAQs

1. Which companies currently supply Depo-Testosterone exclusively in the US?
Pfizer is the sole licensed manufacturer of Depo-Testosterone in the US, until recent generic approvals increased competition.

2. Are there significant regional differences in Depo-Testosterone suppliers?
Yes. In Europe, Ferring and Euromedica dominate; in Asia, Indian companies like Sun Pharma are active; North America relies on Pfizer and generic importers.

3. How does patent status affect the supply of testosterone enanthate?
With patent expiration, multiple generics entered the market, increasing supply and reducing prices. Patent restrictions limit production in certain jurisdictions temporarily.

4. What regulatory hurdles exist for importing Depo-Testosterone?
Importation depends on local laws controlling controlled substances, product registration, and compliance with GMP standards.

5. How can quality be assured from non-branded suppliers?
Verify supplier GMP certification, regulatory approvals, and conduct batch testing if possible. Avoid unverified online sources.


References

[1] U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.
[2] European Medicines Agency. (2022). Summary of Product Characteristics.
[3] Indian Pharmaceutical Alliance. (2022). Generic Drug Market Reports.
[4] Pharmaceutical Research and Manufacturers of America. (2022). Regulatory and Patent Information.

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