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Last Updated: March 26, 2026

Suppliers and packagers for generic pharmaceutical drug: METHYLTESTOSTERONE


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METHYLTESTOSTERONE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Impax Labs Inc METHYLTESTOSTERONE methyltestosterone CAPSULE;ORAL 204851 ANDA Amneal Pharmaceuticals of New York LLC 0115-1408-01 100 CAPSULE in 1 BOTTLE (0115-1408-01) 2015-09-21
Impax Labs Inc METHYLTESTOSTERONE methyltestosterone CAPSULE;ORAL 204851 ANDA Amneal Pharmaceuticals of New York LLC 0115-1408-03 1000 CAPSULE in 1 BOTTLE (0115-1408-03) 2015-09-21
Impax Labs Inc METHYLTESTOSTERONE methyltestosterone CAPSULE;ORAL 204851 ANDA Amneal Pharmaceuticals of New York LLC 0115-1408-08 30 CAPSULE in 1 BOTTLE (0115-1408-08) 2015-09-21
Novitium Pharma METHYLTESTOSTERONE methyltestosterone CAPSULE;ORAL 215270 ANDA ANI Pharmaceuticals, Inc. 70954-255-10 100 CAPSULE in 1 BOTTLE (70954-255-10) 2022-02-18
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug Methyltestosterone

Last updated: February 20, 2026

Methyltestosterone is a synthetic anabolic-androgenic steroid used in hormone therapy, primarily for testosterone deficiency, delayed puberty, and certain types of breast cancer. Its supply chain involves multiple manufacturers, primarily located in countries with established pharmaceutical industries.

Major Manufacturers and Suppliers

1. European/South Asian Producers

  • Bharat Serum: Based in India, supplies methyltestosterone API (Active Pharmaceutical Ingredient) to international markets.
  • Glenmark Pharmaceuticals: India-based firm producing methyltestosterone API with GMP compliance.
  • Hubei Xinjing Pharmaceutical: China-based API manufacturer offering methyltestosterone to global markets.

2. Chinese API Manufacturers

  • Shanghai RK Chemical Technology: Supplies methyltestosterone API to global pharmaceutical companies.
  • Qingdao East Happy Pharmaceutical Co., Ltd.: Offers bulk methyltestosterone API, often utilized by generic drug producers.

3. European API Suppliers

  • Sandoz (Novartis): Historically supplied methyltestosterone in finished form and intermediates.
  • Wassim pharmaceutical: European-based supplier with methyltestosterone API production capacity.

4. United States and Canadian Suppliers

  • Bachem: Produces methyltestosterone for investigational and clinical research purposes.
  • Toronto-based pharma intermediates: Smaller-scale producers providing methyltestosterone raw material.

Market Dynamics and Purchase Considerations

  • Regulatory Status: Methyltestosterone is a controlled substance in several countries. Suppliers adhere to strict regulatory standards, including GMP certification.
  • Pricing Factors: Price varies based on purity, quantity, and regulatory approval status. Indian and Chinese API suppliers typically offer more competitive pricing.
  • Supply Security: Limited number of reputable suppliers can impact supply chain stability.

Regulatory and Compliance Notes

  • Raw material suppliers often require documentation of Good Manufacturing Practices (GMP).
  • Import/export controls may restrict sales depending on jurisdictional regulations.
  • Buyers should verify supplier certification and compliance history before establishing agreements.

Key Competitive Advantages of Leading Suppliers

Supplier Certifications Production Capacity Market Reach Notes
Bharat Serum GMP, ISO Moderate Asia, Africa Established regional presence
Hubei Xinjing Pharmaceutical GMP, ISO High Asia, Europe Focus on API exports
Bachem GMP, cGMP High North America Specializes in research quantities
Shanghai RK Chemical GMP, ISO Moderate Global Competitive pricing, export-centric

Supply Chain Risks

  • Regulatory changes affecting controlled substances.
  • Geographic concentration of API production.
  • Price fluctuations due to raw material costs.

Summary

The primary suppliers of methyltestosterone are located predominantly in India, China, and Europe. Access to these suppliers requires careful evaluation of regulatory compliance, certifications, and supply capacity. While Indian and Chinese API producers dominate the market in terms of volume and cost-effectiveness, European suppliers tend to emphasize regulatory strictness and quality.


Key Takeaways

  • Methyltestosterone suppliers are mainly located in India, China, and Europe.
  • The supply chain is sensitive to regulatory restrictions, especially controlling substances statutes.
  • Price and quality vary significantly among suppliers, with Indian and Chinese manufacturers generally offering more competitive rates.
  • Certification (GMP, ISO) is critical for sourcing pharmaceutical-grade methyltestosterone.
  • Supply risks include regulatory shifts and raw material price volatility.

FAQs

1. Is methyltestosterone available from multiple suppliers globally?
Yes; suppliers are concentrated mainly in India, China, and Europe, with some offerings from North America, but volume and regulatory acceptance vary.

2. What certifications should suppliers possess for pharmaceutical-grade methyltestosterone?
Suppliers should have GMP and ISO certifications to ensure quality and regulatory compliance.

3. Are there restrictions on purchasing methyltestosterone internationally?
Yes; methyltestosterone is a controlled substance with strict import/export controls in many jurisdictions. Buyers must verify local regulations.

4. How does the pricing differ between suppliers?
Indian and Chinese suppliers usually offer lower prices due to lower manufacturing costs, but quality and reliability must be verified.

5. What factors influence supply chain stability for methyltestosterone?
Regulatory changes, production capacity, geopolitical risks, and raw material costs significantly impact supply chain stability.


References

[1] U.S. Food and Drug Administration. (2022). Controlled Substances for Manufacturing.
[2] Indian Pharmaceutical Association. (2021). API Manufacturing Standards.
[3] World Health Organization. (2020). Regulatory Status of Anabolic Steroids.
[4] GlobalData. (2022). Pharmaceutical API Market Overview.
[5] European Medicines Agency. (2021). Quality Standards for APIs.

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