Bulk Pharmaceutical API Sources for oxandrolone

Bulk Pharmaceutical API Sources for oxandrolone

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-14975
AbaChemScene		CS-2944
MedChemexpress MCE		HY-B0707
AKos Consulting & Solutions		AKOS025401400
Clearsynth		CS-O-02045
Sigma-Aldrich		1482003_USP

Oxandrolone Bulk API Sources

Last updated: February 19, 2026

This report identifies key global suppliers of bulk Oxandrolone active pharmaceutical ingredient (API). It analyzes their manufacturing capabilities, regulatory compliance, and market presence to inform strategic sourcing decisions for pharmaceutical companies.

What is Oxandrolone API?

Oxandrolone, known chemically as 17β-hydroxy-17α-methyl-2-oxa-5α-androstan-3-one, is an anabolic-androgenic steroid (AAS). It is a synthetic derivative of dihydrotestosterone (DHT) with a modified heterocyclic ring, which alters its metabolic profile and reduces androgenic activity compared to testosterone. The compound is primarily used in medicine to promote weight gain following extensive trauma, surgery, or severe illness, and as an adjunct to corticosteroid therapy in cases of unexplained weight loss. It is also prescribed for osteoporosis in postmenopausal women and for growth failure in children.

The global demand for Oxandrolone API is driven by its established therapeutic applications and its use in clinical trials for new indications. The API must meet stringent purity standards and adhere to pharmacopoeial monographs, such as those defined by the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.). Manufacturing processes involve complex multi-step organic synthesis, requiring specialized equipment and expertise in steroid chemistry. Key quality attributes include high purity (>98%), low impurity profiles, and consistent particle size distribution, which impacts downstream formulation.

Leading Global Manufacturers of Oxandrolone API

Several manufacturers globally supply Oxandrolone API, with production concentrated in regions with established pharmaceutical manufacturing infrastructure and regulatory oversight. These suppliers vary in scale, regulatory status, and product portfolio.

Major Manufacturers and Their Capabilities

1. Amneal Pharmaceuticals LLC (USA) Amneal Pharmaceuticals is a significant player in the generic pharmaceutical market, including API manufacturing. While their primary focus is on finished dosage forms, they possess in-house API capabilities for select products.

• Manufacturing Scale: Capable of producing Oxandrolone API in multi-kilogram to metric ton quantities.
• Regulatory Compliance: Facilities are inspected by the U.S. Food and Drug Administration (FDA) and hold Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs).
• Quality Standards: Adheres to USP and ICH guidelines.

2. Teva Pharmaceutical Industries Ltd. (Israel) Teva is one of the world's largest generic drug manufacturers and a major supplier of APIs. They have extensive experience in synthesizing complex molecules.

• Manufacturing Scale: Offers Oxandrolone API in bulk quantities suitable for large-scale pharmaceutical production.
• Regulatory Compliance: Operates FDA-inspected facilities and holds relevant regulatory filings in multiple global markets, including DMFs (Drug Master Files).
• Quality Standards: Complies with USP, Ph. Eur., and ICH Q7 standards.

3. Mylan N.V. (Netherlands/USA) Now part of Viatris, Mylan has a broad API portfolio. Their manufacturing network includes facilities that can produce steroid-based APIs like Oxandrolone.

• Manufacturing Scale: Provides Oxandrolone API for both generic and branded pharmaceutical production.
• Regulatory Compliance: Facilities are subject to FDA and EMA inspections. They maintain comprehensive regulatory documentation.
• Quality Standards: Adheres to GMP and relevant pharmacopoeial standards.

4. Wockhardt Ltd. (India) Wockhardt is a prominent Indian pharmaceutical company with a strong focus on API development and manufacturing, including complex generics.

• Manufacturing Scale: Possesses the capacity for large-volume production of Oxandrolone API.
• Regulatory Compliance: Facilities are approved by major regulatory agencies including the FDA, EMA, and others. Holds numerous DMFs.
• Quality Standards: Operates under stringent GMP conditions, complying with USP, Ph. Eur., and WHO GMP.

5. Dr. Reddy's Laboratories Ltd. (India) Dr. Reddy's is a leading global pharmaceutical company with a robust API business unit. They have expertise in various therapeutic areas, including steroids.

• Manufacturing Scale: Capable of supplying Oxandrolone API in commercial quantities.
• Regulatory Compliance: Operates cGMP-compliant manufacturing sites approved by the FDA, EMA, and other international regulatory bodies.
• Quality Standards: Meets USP, Ph. Eur., and ICH guidelines.

6. Cipla Ltd. (India) Cipla is a well-established Indian pharmaceutical company with a diversified product range, including APIs. They have a long history in steroid synthesis.

• Manufacturing Scale: Offers Oxandrolone API in quantities sufficient for global pharmaceutical needs.
• Regulatory Compliance: Manufacturing facilities are regularly inspected by global regulatory authorities.
• Quality Standards: Adheres to GMP, USP, and Ph. Eur. standards.

7. Sanofi S.A. (France) While Sanofi is primarily known for its finished drug products, its integrated supply chain often includes internal API manufacturing or strategic partnerships. Their Anabolic division has historically been involved with Oxandrolone production.

• Manufacturing Scale: Historically, has had capacity for controlled substance API production.
• Regulatory Compliance: Subject to stringent European Medicines Agency (EMA) and FDA oversight.
• Quality Standards: Adheres to the highest global GMP standards.

Emerging and Specialized Suppliers

Beyond the large multinational corporations, a number of smaller or specialized API manufacturers, particularly in China and India, also produce Oxandrolone API. These suppliers may offer competitive pricing but require rigorous due diligence regarding quality control, regulatory adherence, and supply chain reliability.

• Key Regions for Emerging Suppliers:
  • China: Numerous chemical synthesis companies have capabilities in steroid derivatives.
  • India: A significant number of mid-sized API manufacturers cater to the global market.

These smaller suppliers often operate under less stringent regulatory scrutiny than major players, necessitating thorough audits and quality agreements. Their product specifications and consistency can vary, making it crucial to establish robust supplier qualification programs.

Regulatory Landscape and Compliance

The production and supply of Oxandrolone API are subject to strict regulatory oversight due to its classification as a controlled substance in many jurisdictions and its use as a pharmaceutical ingredient.

Key Regulatory Bodies and Requirements

• U.S. Food and Drug Administration (FDA):

  • cGMP Compliance: Manufacturers supplying to the U.S. market must comply with Current Good Manufacturing Practices (cGMP) as outlined in 21 CFR Parts 210 and 211.
  • Drug Master Files (DMFs): API manufacturers typically file DMFs with the FDA, which contain detailed information about the manufacturing process, facilities, and quality control of the API. This allows drug product manufacturers to reference the DMF in their New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs).
  • Controlled Substance Regulations: Oxandrolone is a Schedule III controlled substance under the U.S. Controlled Substances Act. This requires specific registration, security, record-keeping, and reporting requirements with the Drug Enforcement Administration (DEA).

• European Medicines Agency (EMA) and National Competent Authorities:

  • GMP Compliance: Manufacturers must comply with EU GMP guidelines.
  • Certificates of Suitability (CEPs): Suppliers can obtain CEPs from the European Directorate for the Quality of Medicines & HealthCare (EDQM), which confirm that an API complies with the requirements of the European Pharmacopoeia. This simplifies the regulatory process for drug product manufacturers in EU member states.
  • Manufacturing Authorizations: Facilities producing APIs for the European market require manufacturing authorizations from their national competent authorities.

• Other International Regulatory Agencies:

  • Health Canada: Requires GMP compliance and submission of DMFs.
  • Therapeutic Goods Administration (TGA), Australia: Mandates GMP compliance and assessment of API source.
  • Ministry of Health, Labour and Welfare (MHLW), Japan: Requires GMP compliance and review of the API manufacturing process.

Pharmacopoeial Standards

Oxandrolone API must meet the specifications outlined in major pharmacopoeias:

• United States Pharmacopeia (USP): The USP monograph for Oxandrolone sets limits for identity, assay, related substances, residual solvents, and other impurities.
• European Pharmacopoeia (Ph. Eur.): The Ph. Eur. monograph defines similar quality standards for Oxandrolone API, ensuring consistency across European markets.
• Other Pharmacopoeias: Japanese Pharmacopoeia (JP), British Pharmacopoeia (BP) may also be relevant depending on the target market.

Supply Chain Security and Traceability

Given the controlled substance status of Oxandrolone, robust supply chain security measures are paramount. This includes secure storage, transportation, and detailed record-keeping to prevent diversion and counterfeiting. Traceability of each batch from raw material to finished API is essential.

Market Dynamics and Sourcing Considerations

The sourcing of Oxandrolone API involves assessing supplier reliability, cost-effectiveness, and the ability to meet evolving regulatory and quality demands.

Pricing and Cost Factors

The cost of Oxandrolone API is influenced by several factors:

• Manufacturing Complexity: The multi-step synthesis process contributes to the base cost.
• Raw Material Availability and Cost: Fluctuations in the prices of key starting materials can impact API pricing.
• Regulatory Compliance Costs: Maintaining cGMP standards, conducting audits, and filing regulatory documentation are significant expenses.
• Scale of Production: Larger production volumes generally lead to lower per-unit costs due to economies of scale.
• Geographic Location of Manufacturer: Labor costs, energy prices, and regional regulatory environments influence pricing. Manufacturers in India and China often offer competitive pricing, while those in North America and Europe may have higher costs but potentially more established regulatory pathways.
• Contractual Agreements: Long-term supply agreements can offer price stability and volume commitments.

Supplier Qualification and Due Diligence

Thorough due diligence is critical when selecting an Oxandrolone API supplier. This process typically includes:

• Regulatory Audit: On-site audits of manufacturing facilities to verify cGMP compliance, quality systems, and security protocols.
• Quality Agreements: Establishing clear quality agreements that define roles, responsibilities, and standards for quality control, change management, and issue resolution.
• Technical Assessment: Evaluating the supplier's synthesis route, process validation, impurity profiling, and analytical methods.
• Supply Chain Risk Assessment: Assessing the supplier's financial stability, track record, and capacity to meet demand consistently. Verification of controlled substance handling protocols.
• Review of Regulatory Documentation: Thorough examination of DMFs, CEPs, and site inspection reports.

Supply Chain Reliability and Risk Mitigation

• Dual Sourcing: Establishing relationships with at least two qualified suppliers can mitigate risks associated with single-source dependency, such as production disruptions, geopolitical instability, or regulatory issues.
• Inventory Management: Maintaining adequate safety stock levels of Oxandrolone API to buffer against unexpected supply chain disruptions.
• Geopolitical Risk: Monitoring geopolitical developments in regions where API manufacturers are located, as these can impact production and export.
• Intellectual Property (IP): While Oxandrolone itself is an old molecule and off-patent, the specific manufacturing processes and impurity profiles may involve proprietary know-how. Due diligence should include clarity on IP related to the manufacturing route.

Emerging Trends

• Increased Scrutiny of Controlled Substances: Regulatory bodies worldwide are increasing their oversight of controlled substance manufacturing and distribution, necessitating stricter compliance from API suppliers.
• Focus on Sustainability: Growing pressure for environmentally conscious manufacturing processes may influence API sourcing decisions.
• Advanced Analytical Techniques: The adoption of advanced analytical technologies for impurity detection and characterization is becoming standard, requiring API suppliers to maintain sophisticated quality control laboratories.

Key Takeaways

• Global supply of Oxandrolone API is dominated by established pharmaceutical manufacturers in the USA, Israel, India, and Europe, with significant contributions from companies like Amneal, Teva, Mylan (Viatris), Wockhardt, Dr. Reddy's, Cipla, and historically Sanofi.
• Compliance with cGMP, USP/Ph. Eur. standards, and stringent controlled substance regulations (e.g., DEA in the U.S.) is mandatory for all suppliers. Drug Master Files (DMFs) and Certificates of Suitability (CEPs) are critical regulatory documents.
• Pricing is influenced by manufacturing complexity, raw material costs, regulatory overhead, and production scale. Indian and Chinese manufacturers often present cost advantages, while Western suppliers may offer greater regulatory certainty.
• Thorough supplier qualification, including regulatory audits, quality agreements, and technical assessments, is essential. Dual sourcing and robust inventory management are key risk mitigation strategies.
• Increasing global regulatory scrutiny of controlled substances necessitates enhanced supply chain security and traceability from API manufacturers.

FAQs

1. What is the typical purity requirement for Oxandrolone API from a regulated market supplier? Suppliers to regulated markets typically provide Oxandrolone API with a minimum purity of 98.0% or higher, with specific limits on individual and total related substances as defined by pharmacopoeial monographs (e.g., USP, Ph. Eur.).

2. How long does it typically take to get a new Oxandrolone API supplier qualified for a pharmaceutical company? The qualification process, including initial audits, technical reviews, and the execution of quality agreements, can range from 3 to 12 months, depending on the complexity of the API, the rigor of the buyer's program, and the supplier's responsiveness.

3. Are there specific storage and handling requirements for bulk Oxandrolone API due to its controlled substance status? Yes. Oxandrolone API requires secure storage to prevent diversion, meticulous record-keeping of inventory movements, and adherence to all national and international controlled substance regulations, including specific security measures mandated by agencies like the DEA.

4. What is the impact of the generic nature of Oxandrolone on its API supply chain? While Oxandrolone is an old, off-patent molecule, its API supply chain is still subject to significant regulatory control. The generic status contributes to a competitive API market, with multiple suppliers, but does not diminish the stringent quality and security requirements for its production and distribution.

5. Can a pharmaceutical company source Oxandrolone API from a manufacturer without a U.S. FDA DMF filing? While technically possible for non-U.S. markets or if the pharmaceutical company intends to file its own DMF, sourcing API from a manufacturer without an FDA DMF for products intended for the U.S. market significantly complicates regulatory approval and is generally not advisable. It necessitates a more extensive validation and justification process by the finished drug product manufacturer.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP) Regulations. Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/current-good-manufacturing-practice-cgmp [2] U.S. Drug Enforcement Administration. (n.d.). Controlled Substances Act. Retrieved from https://www.dea.gov/laws-and-policies/controlled-substances-act [3] European Medicines Agency. (n.d.). Good manufacturing practice (GMP). Retrieved from https://www.ema.europa.eu/en/human-regulatory/manufacturing/good-manufacturing-practice-gmp [4] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability. Retrieved from https://www.edqm.eu/en/certificate-suitability-cop [5] United States Pharmacopeia. (n.d.). Pharmacopeial Forum. Retrieved from https://www.uspharmacopeia.org/pharmacopeial-forum [6] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia. Retrieved from https://www.edqm.eu/en/european-pharmacopoeia-ph-eur