Nandrolone

In response to the problem of protein metabolism imbalance caused by degenerative diseases of the motor system and chronic consumptive diseases, anabolic androgenic steroids are an important clinical option for improving the nutritional status of the body. As a classic 19-nortestosterone derivative, nandrolone binds to androgen receptors and has both strong protein assimilation effect and weak androgenic activity. It can promote the synthesis of proteins from amino acids, inhibit protein decomposition, increase calcium and phosphorus deposition, and accelerate the growth of bone tissue. Clinically, it is mainly used for the treatment of osteoporosis, palliative treatment of advanced breast cancer, chronic consumptive diseases and weight loss before and after surgery, etc. It can also assist in improving the tissue repair process of patients with burns and refractory fractures, and the applicable population covers elderly patients with bone diseases, patients with tumor cachexia and patients in the trauma repair period.

The global market size of nandrolone preparations is approximately USD 120 million. Driven by the rising prevalence of senile osteoporosis and the growing demand for clinical nutrition support in recent years, the compound annual growth rate has remained at around 3.8%. The competitive landscape is dominated by generic drugs, with the original research product accounting for less than 15% of the market. The global API production capacity is mainly concentrated in China and India, and domestic enterprises, with their compliance advantages, account for nearly 40% of the share in the regulated markets of Europe and the United States. The domestic preparation market has not yet been included in centralized procurement. At present, there are 7 domestic generic drug preparation approvals in total, and the market competition is relatively gentle.

The original research enterprise of nandrolone is Pfizer, with the original brand name Deca-Durabolin, and its core compound patent expired worldwide in 1986. The mainstream dosage form of the original product is injection, with specifications of 25mg/ml, 50mg/ml and 100mg/ml. It has been included in the FDA Reference Listed Drug Catalog, and is also included in the China Listed Drug Catalog. Up to now, there is no A status registration number of nandrolone on the domestic CDE API registration platform, and all marketed preparations are declared with imported APIs, with a total of 3 valid imported API DMF numbers. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of nandrolone impurity reference standards, which can accurately match the impurity research needs under different processes. All products meet the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA, and most of the products are in stock. In-stock orders placed before 16:00 can be shipped on the same day, which efficiently supports the whole process of API R&D, quality research and declaration.

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