Hormone APIs
Premium Steroid Hormones and Endocrine Active Pharmaceutical Ingredients
About Hormone APIs
Holiness Pharmaceutical specializes in the manufacturing and export of high-quality Hormone APIs used in hormone replacement therapy, endocrine disorders, and therapeutic applications. Our portfolio includes testosterone derivatives, progesterone compounds, anabolic steroids, and other hormone-based active ingredients produced under strict WHO-GMP regulations.
Key Features
- WHO-GMP certified hormone manufacturing facility
- Compliance with BP, USP, and EP pharmacopoeial standards
- Advanced steroid synthesis technology
- Controlled substance manufacturing expertise
- Comprehensive impurity profiling and stability data
- Regulatory documentation for global markets
- Secure supply chain with proper handling protocols
- Custom esterification and formulation support
Application Areas
Hormone Replacement Therapy (HRT)
APIs for treating hormonal deficiencies in men and women
Anabolic Steroids
Therapeutic anabolic agents for muscle wasting and medical conditions
Women's Health
Progesterone and estrogen compounds for reproductive health
Endocrine Disorders
Hormonal agents for thyroid, adrenal, and pituitary conditions
Quality Assurance
Our hormone APIs are manufactured in dedicated facilities with stringent environmental controls. Each batch undergoes comprehensive testing including potency assays, related substance analysis, residual solvent testing, and microbiological evaluation to ensure pharmaceutical grade quality.
Our Hormone APIs Products
| Product Name | CAS Number | Grade | Form | Actions |
|---|---|---|---|---|
Testosterone Enanthate API | 315-37-7 | BP/USP/EP | API Powder | View Product |
Drostanolone Enanthate API | 13425-31-5 | BP/USP/EP | API Powder | View Product |
Hydroxyprogesterone Caproate API | 630-56-8 | BP/USP/EP | API Powder | View Product |
Nandrolone API | 434-22-0 | BP/USP/EP | API Powder | View Product |
Nandrolone Decanoate API | 360-70-3 | BP/USP/EP | API Powder | View Product |
Oxandrolone API | 53-39-4 | BP/USP/EP | API Powder | View Product |
Progesterone API | 57-83-0 | BP/USP/EP | API Powder | View Product |
Testosterone API | 58-22-0 | BP/USP/EP | API Powder | View Product |
Testosterone Cypionate API | 58-20-8 | BP/USP/EP | API Powder | View Product |
Testosterone Enanthate API | 315-37-7 | BP/USP/EP | API Powder | View Product |
Frequently Asked Questions
What are Hormone APIs?
Hormone APIs are active pharmaceutical ingredients that mimic or supplement natural hormones in the body. These include steroid hormones like testosterone, progesterone, and their derivatives used in hormone replacement therapy, endocrine disorder treatment, and various therapeutic applications.
Which hormone APIs does Holiness Pharmaceutical manufacture?
We manufacture a comprehensive range including Testosterone (base and esters like Enanthate, Cypionate, Propionate), Nandrolone Decanoate, Progesterone, Hydroxyprogesterone Caproate, Oxandrolone, and Drostanolone Enanthate. All products meet international pharmacopeial standards.
Are hormone APIs controlled substances?
Yes, many hormone APIs including anabolic steroids are controlled substances in various countries. We maintain all necessary licenses and permits for manufacturing controlled substances and provide complete documentation for legal import and export in compliance with international regulations.
What quality standards apply to your Hormone APIs?
Our hormone APIs are manufactured in WHO-GMP certified facilities and comply with BP, USP, and EP pharmacopeial standards. We conduct comprehensive testing including potency, purity, related substances, residual solvents, heavy metals, and microbiological testing for each batch.
Do you provide documentation for controlled substances?
Yes, we provide all necessary documentation including import/export licenses, Certificate of Analysis, manufacturing licenses for controlled substances, Drug Master Files, and regulatory support for registration in various countries. Our team assists with compliance requirements.
Can you manufacture custom hormone esters?
Yes, we offer custom esterification services for various hormone molecules. Our R&D team can develop specific esters with desired pharmacokinetic properties and scale up the manufacturing process from development to commercial production.
How do you ensure product stability for Hormone APIs?
We conduct comprehensive stability studies under ICH guidelines including long-term, accelerated, and stress testing. Our products are packaged in appropriate containers with proper labeling and storage recommendations. Stability data is provided with Certificate of Analysis.
What is the typical lead time for hormone API orders?
Lead times vary depending on the specific product, quantity, and regulatory requirements. Standard products typically have 4-8 weeks lead time, while custom synthesis may require longer. We maintain strategic inventory of key products to ensure timely delivery.