Testosterone Undecanoate API (CAS No. 5949-44-0) is a long-acting testosterone ester widely used in hormone replacement therapy (HRT) and androgen-related formulations. As a leading GMP- and ISO-certified API manufacturer and supplier, Amber Lifesciences Pvt. Ltd. provides bulk API to pharmaceutical companies worldwide for regulated and semi-regulated markets.
Our API complies with global pharmacopeial standards (USP/EP/JP) and is supported with complete regulatory documentation, making it a trusted choice for pharma companies developing injectable and oral testosterone therapies.
Chemical & Physical Properties of Testosterone Undecanoate API
- IUPAC Name: [(8R,9S,10R,13S,14S,17S)-17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-3-yl] undecanoate
- Molecular Formula: C₃₀H₄₈O₃
- Molecular Weight: 456.7 g/mol
- Appearance: White or almost white crystalline powder
- Solubility: Practically insoluble in water; soluble in ethanol and oils
Testosterone Undecanoate API Mechanism & Functional Role
Testosterone Undecanoate acts as a prodrug of testosterone. Once administered, it is hydrolyzed to release free testosterone, which binds to androgen receptors, supporting:
- Maintenance of healthy muscle mass and strength
- Bone density and skeletal health
- Energy, vitality, and sexual function
- Overall hormonal balance in men with testosterone deficiency
Testosterone Undecanoate API Pharmacokinetic Profile
- Half-life (Injection): ~34 days, ensuring long-lasting effects
- Absorption:
- Oral capsules: Absorbed via the lymphatic system, bypassing first-pass metabolism
- Injectable formulations: Provide slow release from an intramuscular depot over weeks
- Metabolism: Hydrolyzed into active testosterone before systemic distribution
Formulation Opportunities with Testosterone Undecanoate API
Amber Lifesciences supplies Testosterone Undecanoate API as a high-quality raw material for various dosage forms, including:
- Injectable Solutions:
- Example: Nebido® (1000 mg/4 mL intramuscular injection every 10–14 weeks)
- Long-acting formulations for sustained testosterone release
- Oral Capsules:
- Example: Andriol® (40 mg softgel capsules)
- Requires administration with fatty meals for optimal absorption
These formulation pathways make it a versatile androgen replacement therapy ingredient, suitable for large-scale commercial production.
Manufacturing & Quality Assurance by Amber Lifesciences
At Amber Lifesciences, every batch of Testosterone Undecanoate API undergoes stringent quality checks:
- GMP- and ISO-certified production
- HPLC/GC purity testing (≥98%)
- Impurity profiling of related steroids
- Residual solvent analysis
- Stability studies under ICH guidelines
- Pharmacopeia compliance (USP/EP/JP)
Testosterone Undecanoate API: Global Supply & Regulatory Support
Amber Lifesciences provides bulk Testosterone Undecanoate API with full regulatory documentation, including:
- Certificate of Analysis (CoA)
- Material Safety Data Sheet (MSDS)
- Technical dossiers & DMF support (on request)
- Change control and batch traceability systems
We serve regulated and semi-regulated markets across Europe, MENA, LATAM, and Asia-Pacific, ensuring consistent supply and global distribution support.
Conclusion
Testosterone Undecanoate API is a cornerstone in long-acting testosterone replacement therapies, offering flexibility in both injectable and oral formulations. With GMP-certified manufacturing, pharmacopeia compliance, and proven export expertise, Amber Lifesciences Pvt. Ltd. is a trusted global supplier of bulk Testosterone Undecanoate API to pharmaceutical companies.
If you are looking to buy Testosterone Undecanoate API in bulk, partner with Amber Lifesciences for consistent quality, regulatory support, and reliable international delivery.