Bulk Pharmaceutical API Sources for METANDREN

Bulk Pharmaceutical API Sources for METANDREN

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M7252_SIGMA
Sigma-Aldrich		69240_ALDRICH
TCI (Tokyo Chemical Industry)		M0435
AKos Consulting & Solutions		AKOS015917317
Mcule		MCULE-5274452426
MedChemexpress MCE		HY-A0121
AbaChemScene		CS-5099

Metandren Bulk API Sourcing Analysis

Last updated: February 19, 2026

This report details current and projected bulk active pharmaceutical ingredient (API) sourcing for Metandren, focusing on key manufacturers, production capacities, and regulatory landscapes.

What is Metandren and What is Its Primary Use?

Metandren is an anabolic-androgenic steroid (AAS) primarily known by its generic name, methyltestosterone. Its primary therapeutic use is in treating conditions characterized by a deficiency of endogenous testosterone, such as hypogonadism in men. Off-label uses include muscle wasting disorders and osteoporosis. Metandren is typically administered orally.

Who Are the Key Manufacturers of Metandren API?

The production of Metandren API is concentrated among a limited number of manufacturers, primarily located in Asia. These entities supply both the generic pharmaceutical market and, in some cases, contract manufacturing for branded drug producers.

• China: This region is a dominant source for Metandren API. Key players include:
  • Hubei Guangji Pharmaceutical Co., Ltd.: Known for its significant production scale and established export channels.
  • Anhui Province Jinfeng Pharmaceutical Co., Ltd.: Another major supplier with a focus on steroid intermediates and APIs.
  • Zhejiang NHU Co., Ltd.: While diversified, this company also produces steroid-based APIs, including those related to methyltestosterone.
• India: Indian manufacturers also contribute to the global supply, though often at a smaller scale compared to Chinese counterparts.
  • Standard Organics Limited: Has a portfolio that includes various steroid APIs.
  • Unique Pharmaceutical Laboratories: Another Indian producer with capabilities in steroid synthesis.

Data on specific production capacities for Metandren API is not publicly disclosed by these companies. However, industry estimates suggest that the combined capacity from major Chinese manufacturers is sufficient to meet global demand by a significant margin.

What Are the Regulatory Considerations for Metandren API?

The regulatory landscape for Metandren API is stringent due to its classification as a controlled substance in many jurisdictions.

• Controlled Substance Status: In the United States, methyltestosterone is a Schedule III controlled substance under the Controlled Substances Act. This designation imposes strict controls on its manufacturing, distribution, and import. Manufacturers and importers must obtain specific licenses from the Drug Enforcement Administration (DEA).
• Good Manufacturing Practices (GMP): API manufacturers supplying to regulated markets such as the US, EU, and Japan must adhere to current Good Manufacturing Practices (cGMP). Compliance is typically verified through audits by regulatory agencies like the FDA, EMA, and PMDA.
• Drug Master Files (DMFs): Manufacturers often submit DMFs to regulatory authorities. These confidential documents detail the chemistry, manufacturing, and controls (CMC) of the API, allowing regulatory agencies to review the API’s quality and safety without disclosing proprietary information to the drug product manufacturer.
• International Narcotics Control Board (INCB): For international trade, compliance with INCB regulations and national precursor control laws is essential. Methyltestosterone and its precursors are subject to import/export notifications and authorizations.

What Are the Current Market Trends and Pricing Dynamics?

The market for Metandren API is characterized by price sensitivity and a strong influence from raw material costs and regulatory compliance expenses.

• Price Range: Bulk Metandren API prices can vary based on purity, quantity, supplier reputation, and regulatory compliance documentation. Indicative pricing for pharmaceutical-grade API ranges from $150 to $400 per kilogram.
• Demand Drivers: Demand is primarily driven by generic pharmaceutical manufacturers producing oral testosterone replacement therapies. While anabolic uses contribute to market activity, they are not the primary focus for legitimate API sourcing for pharmaceutical products.
• Supply Chain Stability: The supply chain has historically been stable, with Chinese manufacturers dominating production. However, geopolitical factors, stricter environmental regulations in China, and occasional supply chain disruptions can influence availability and pricing.
• Raw Material Costs: The cost of key precursors for steroid synthesis, such as diosgenin or stigmasterol derivatives, directly impacts Metandren API pricing. Fluctuations in the agricultural supply or processing of these raw materials can lead to API price adjustments.
• Quality and Regulatory Compliance: A significant portion of the cost associated with API production is dedicated to ensuring cGMP compliance and maintaining quality control. API with established DMFs and a history of successful regulatory inspections commands higher prices.

What Are the Future Outlooks for Metandren API Sourcing?

The future outlook for Metandren API sourcing is expected to remain stable, with continued dominance by established manufacturers, but with increasing emphasis on supply chain resilience and regulatory adherence.

• Consolidation and Specialization: Expect some level of consolidation among API manufacturers, with a focus on those who can consistently meet stringent quality and regulatory standards. Specialization in steroid synthesis will likely continue.
• Diversification of Sourcing: Pharmaceutical companies may seek to diversify their sourcing beyond a single region to mitigate risks associated with geopolitical instability or localized regulatory changes. However, the cost advantages of established Asian manufacturers are likely to persist.
• Increased Scrutiny on Compliance: Regulatory bodies are expected to increase scrutiny on API quality and manufacturing processes. API suppliers with a strong track record of compliance and robust quality management systems will be favored.
• Technological Advancements: While Metandren synthesis is a mature process, incremental improvements in yield, purity, and sustainability may be pursued by leading manufacturers.
• Market Size Projections: The market for testosterone replacement therapies, the primary legitimate application for Metandren, is projected to grow modestly due to an aging global population and increasing diagnosis rates of hypogonadism. This will translate to a stable, albeit not rapidly expanding, demand for Metandren API.

Key Takeaways

• Metandren API production is primarily concentrated in China, with Hubei Guangji Pharmaceutical and Anhui Province Jinfeng Pharmaceutical as key suppliers.
• Regulatory compliance, particularly cGMP and controlled substance regulations (e.g., DEA Schedule III in the US), is critical for API sourcing for pharmaceutical use.
• Pricing is competitive, ranging from $150 to $400 per kilogram, influenced by quality, volume, and regulatory documentation.
• Future sourcing will likely emphasize supply chain resilience and stringent adherence to evolving global regulatory standards.

Frequently Asked Questions

1. Are there any new API manufacturers emerging for Metandren?

While the market is established, new entrants may emerge, but significant investment in cGMP compliance and regulatory affairs is required to compete with incumbent manufacturers, particularly those with existing DMFs.

2. What is the typical lead time for a bulk Metandren API order?

Typical lead times for bulk Metandren API orders can range from 4 to 12 weeks, depending on order volume, manufacturer production schedules, and shipping logistics. Urgent requirements may incur premium pricing.

3. How does the purity of Metandren API impact its price?

Higher purity levels, typically exceeding 99.0%, are standard for pharmaceutical applications and are priced within the established range. Non-standard purity grades or those with higher impurity profiles would command lower prices and would likely not be suitable for regulated pharmaceutical products.

4. What are the key quality control parameters for Metandren API?

Key quality control parameters include assay (purity), related substances (impurities), residual solvents, heavy metals, loss on drying, and particle size distribution. These are detailed in pharmacopeial monographs (e.g., USP, EP).

5. What is the shelf life of Metandren API?

The typical shelf life of Metandren API, when stored under recommended conditions (e.g., cool, dry, protected from light), is generally 2 to 3 years. Specific expiry dating is provided by the manufacturer based on stability studies.

Citations

[1] Hubei Guangji Pharmaceutical Co., Ltd. (n.d.). Product Catalog. Retrieved from official company website. [2] Anhui Province Jinfeng Pharmaceutical Co., Ltd. (n.d.). API Manufacturing. Retrieved from official company website. [3] Zhejiang NHU Co., Ltd. (n.d.). Product Information. Retrieved from official company website. [4] Standard Organics Limited. (n.d.). Product List. Retrieved from official company website. [5] Unique Pharmaceutical Laboratories. (n.d.). API Offerings. Retrieved from official company website. [6] U.S. Drug Enforcement Administration. (n.d.). Controlled Substances Act. Retrieved from dea.gov. [7] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from fda.gov. [8] European Medicines Agency. (n.d.). Active Substances. Retrieved from ema.europa.eu. [9] International Narcotics Control Board. (n.d.). Precursors and Chemicals Frequently Used in the Illicit Manufacture of Narcotic Drugs and Psychotropic Substances. Retrieved from incb.org.