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Nandrolone decanoate | CAS No: 360-70-3 | GMP-certified suppliers
A medication that supports management of anemia linked to renal insufficiency and serves as adjunct therapy for senile and postmenopausal osteoporosis in key markets.
Therapeutic categories
Primary indications
- Nandrolone decanoate is indicated in the management of anemia of renal insufficiency
- In Canada, it is also indicated as an adjunct therapy in the treatment of senile and postmenopausal osteoporosis
Product Snapshot
- This is an intramuscular injectable small‑molecule steroid API
- Its primary uses are in anemia associated with renal insufficiency and, in Canada, as an adjunct in senile and postmenopausal osteoporosis
- It is approved in the US and Canada for specified indications, with some markets also classifying it as an illicit substance outside regulated channels
Clinical Overview
Pharmacologically, nandrolone decanoate acts as an anabolic androgen with a relatively wide therapeutic window. After administration, the ester is hydrolyzed to active nandrolone, a process that may involve PDE7B. Released nandrolone enters cells via receptor‑mediated mechanisms and binds to the androgen receptor. Receptor binding triggers conformational changes that enable nuclear translocation, dimerization, and subsequent interaction with specific DNA sequences to modulate gene transcription. Androgen signaling can also intersect with non‑genomic pathways, including ERK, Akt, and MAPK, contributing to broader regulatory effects on protein synthesis and erythropoiesis.
Absorption from the intramuscular depot is slow and sustained due to the lipophilic decanoate ester. Distribution and metabolism are driven by steroid‑processing pathways, including conjugation via UGT1A1, UGT1A3, UGT1A4, and UGT2B7. The prolonged release profile underlies its extended clinical activity. Elimination occurs through hepatic metabolism and renal excretion of conjugated metabolites.
Safety considerations include potential fluid retention, effects on lipid parameters, and risk of worsening cardiac, renal, or hepatic impairment. Androgenic effects may occur with supratherapeutic exposure or misuse. Acute overdose is uncommon due to the depot formulation, but chronic high‑dose use is associated with well‑characterized anabolic steroid toxicities. The product is approved for medical use but is also encountered in illicit performance‑enhancing settings.
Nandrolone decanoate is marketed globally in injectable depot formulations. For API procurement, sourcing should prioritize verification of ester identity, impurity control specific to steroidal intermediates, and compliance with regional pharmacopoeial specifications to ensure consistent quality for formulation development.
Identification & chemistry
| Generic name | Nandrolone decanoate |
|---|---|
| Molecule type | Small molecule |
| CAS | 360-70-3 |
| UNII | H45187T098 |
| DrugBank ID | DB08804 |
Pharmacology
| Summary | Nandrolone decanoate is a prodrug that releases nandrolone, an anabolic androgen that engages the androgen receptor to modulate gene transcription and downstream signaling pathways. Its pharmacologic activity promotes erythropoiesis and tissue anabolic effects, supporting its use in anemia of renal insufficiency and, in some regions, osteoporosis. Secondary interactions with pathways such as ERK, Akt, and MAPK contribute to its broader transcriptional and metabolic effects. |
|---|---|
| Mechanism of action | Nandrolone decanoate is hydrolyzed to [nandrolone], possibly by PDE7B.Nandrolone is brought into cells by receptor mediated endocytosis, where it interacts with the androgen receptor.After binding to the androgen receptor, a conformational change occurs, the androgen receptor enters the nucleus, dimerizes, and can then bind to segments of DNA to regulate transcription.Androgens can also regulate transcription through activation of ERK, Akt, and MAPK; or binding to and competitively inhibiting transcription factors. |
| Pharmacodynamics | Nandrolone decanoate is an alkylated anabolic steroid indicated in the management of anemia of renal insufficiency and as an adjunct therapy in the treatment of senile and postmenopausal osteoporosis.It has a long duration of action as it is given every 3-4 weeks, and a wide therapeutic window as acute overdoses are rare.Patients should be counselled regarding the risks of giving this drug to patients with cardiac, renal, or hepatic diseases. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Androgen receptor | Humans | agonist |
| Proto-oncogene c-Fos | Humans | inducer |
| 5-hydroxytryptamine 2 receptor | Humans | modulator |
ADME / PK
| Absorption | A 50 mg intramuscular dose of nandrolone decanoate reaches a mean C<sub>max</sub> 2.14 ng/mL, with a mean T<sub>max</sub> of 30 hours, and a mean AUC of 400 h\*ng/mL.A 100 mg intramuscular dose of nandrolone decanoate reaches a mean C<sub>max</sub> 4.26 ng/mL, with a mean T<sub>max</sub> of 30 hours, and a mean AUC of 862 h\*ng/mL.A 150 mg intramuscular dose of nandrolone decanoate reaches a mean C<sub>max</sub> 5.16 ng/mL, with a mean T<sub>max</sub> of 72 hours, and a mean AUC of 1261 h\*ng/mL. |
|---|---|
| Half-life | Nandrolone decanoate has an absorption half life of 6 days and an elimination half life of 4.3 hours.Alternate studies have shown that nandrolone decanoate has a terminal half life of 7.1, 11.7, and 11.8 hours for doses of 50, 100, and 150 mg respectively. |
| Protein binding | Data regarding the percent protein binding of nandrolone decanoate is not readily available. After nandrolone decanoate is hydrolyzed to [nandrolone], it is bound to sex hormone binding globulin. |
| Metabolism | Nandrolone decanoate is hydrolyzed to [nandrolone], possibly by PDE7B.Nandrolone is further metabolized to the urinary metabolites 19-norandrosterone, 19-noretiocholanolone, and 19-norepiandrosterone.19-norandrosterone is 3-O-glucuronidated by UGT2B7, UGT 1A4, UGT2B4, UGT1A3, and UGT1A1.19-noretiocholanolone is 3-O-glucuronidated by UGT2B7, UGT2B4, UGT1A4, UGT1A10, UGT1A3, and UGT1A1. |
| Route of elimination | Nandrolone decanoate is eliminated as urinary metabolites, however data regarding elimination in the feces are not readily available.Data in cattle shows that [nandrolone] is 30% eliminated in the feces. |
| Clearance | 50 mg, 100 mg, and 150 mg doses of nadrolone decanoate had mean apparent clearances of 80.0 L/h, 74.3 L/h, and 76.2 L/h respectively. |
Formulation & handling
- Nandrolone decanoate is a highly lipophilic steroid ester requiring formulation as an oil-based intramuscular or parenteral solution due to extremely low aqueous solubility.
- The esterified structure provides pro‑drug characteristics with slow in vivo release, supporting depot-type formulations and necessitating attention to solvent and viscosity selection.
- The solid API should be protected from hydrolysis and oxidation during handling, with controlled-temperature storage to maintain ester stability.
Regulatory status
| Lifecycle | Patent protection in the United States and Canada appears to be nearing or past typical expiry timelines, suggesting the API is in a mature phase of its lifecycle. Market activity in both regions is consistent with increasing generic presence and stable, established demand. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Nandrolone decanoate was originally introduced by a single originator company, but its patents have long expired, and manufacturing is now dominated by multiple generic producers. Branded and non‑branded products are established in markets such as the US and Canada, with historical global availability in many other regions. The long‑expired patent status supports broad existing generic competition across the supply chain. |
|---|
Safety
| Toxicity | Data regarding acute overdose of nandrolone decanoate are not readily available.However, patients experiencing a chronic overdose of anabolic steroids may experience adverse effects including suppression of testosterone and spermatogenesis, shrinking of testicles, decreased libido, and erectile dysfunction in men; and suppressed estrogen, progesterone, and ovulation, amenorrhea, and clitoromegaly in women.Patients may also experience neuropsychiatric, cardiovascular, and hepatic adverse effects.Alkylated anabolic steroids such as nandrolone decanoate are more likely to cause hepatic adverse effects.Treat patients with symptomatic and supportive measures. The intraperitoneal LD<sub>50</sub> in mice is >566 mg/kg. |
|---|
- Chronic high exposure is associated with endocrine suppression, including reduced testosterone production, impaired spermatogenesis, and potential ovarian suppression with virilizing effects
- Neuropsychiatric, cardiovascular, and hepatic toxicities have been observed, with alkylated anabolic steroids showing increased risk for hepatic impairment
- Intraperitoneal LD50 in mice is reported as greater than 566 mg/kg, indicating relatively low acute toxicity in this model but not excluding risk with sustained or excessive exposure
Good Manufacturing Practices
Active pharmaceutical ingredients are made in GMP-certified manufacturing facilities. GMP stands for Good Manufacturing Practices and is the main standard in the pharmaceutical industry. cGMP or Current GMP means that the company complies with the most recent requirements/version of GMP. The WHO has its own guideline for GMP, the World Health Organization or WHO GMP. The authority that has audited the company can also be from a country like China (Chinese GMP) or from the EU (EU GMP), every authority has different GMP requirements.
Nandrolone decanoate is a type of Androgens
Androgens are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in hormone replacement therapy and various other medical applications. They are a class of hormones that primarily include testosterone and its derivatives, which are responsible for the development and maintenance of male characteristics in the body.
Androgens are commonly used in the treatment of conditions such as hypogonadism, delayed puberty, androgen deficiency syndromes, and certain types of breast cancer. They work by binding to and activating the androgen receptors in cells, regulating gene expression and influencing the development and functioning of various tissues and organs.
Pharmaceutical companies produce androgens as API compounds to ensure precise dosage and efficacy in pharmaceutical formulations. These APIs undergo rigorous testing and quality control measures to meet regulatory standards and ensure patient safety.
The availability of androgens as APIs enables the formulation of different dosage forms such as tablets, injections, gels, and transdermal patches. These formulations provide healthcare professionals with various options for administration, allowing them to tailor treatment regimens according to individual patient needs.
It is essential for pharmaceutical companies to maintain strict quality control and adhere to Good Manufacturing Practices (GMP) during the production of androgens APIs. This ensures consistent potency, purity, and bioavailability of the APIs, ultimately leading to safe and effective medications for patients.
In conclusion, androgens are a vital subcategory of pharmaceutical APIs used in hormone replacement therapy and the treatment of various medical conditions. Their precise production and formulation allow for effective therapeutic interventions, promoting optimal patient outcomes.
Nandrolone decanoate (Androgens), classified under Hormonal Agents
Hormonal agents are a prominent category of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the medical field. These substances play a crucial role in regulating and modulating hormonal functions within the body. Hormonal agents are designed to mimic or manipulate the effects of naturally occurring hormones, allowing healthcare professionals to treat various endocrine disorders and hormonal imbalances.
Hormonal agents are commonly employed in the treatment of conditions such as hypothyroidism, hyperthyroidism, diabetes, and hormonal cancers. These APIs work by interacting with specific hormone receptors, either by stimulating or inhibiting their activity, to restore the balance of hormones in the body. They can be administered orally, intravenously, or through other routes depending on the specific medication and patient needs.
Pharmaceutical companies employ rigorous manufacturing processes and quality control measures to ensure the purity, potency, and safety of hormonal agent APIs. These APIs are synthesized using chemical or biotechnological methods, often starting from natural hormone sources or through recombinant DNA technology. Stringent regulatory guidelines are in place to guarantee the efficacy and safety of hormonal agent APIs, ensuring that patients receive high-quality medications.
As the demand for hormone-related therapies continues to grow, ongoing research and development efforts focus on enhancing the effectiveness and reducing the side effects of hormonal agent APIs. This includes the exploration of novel delivery systems, advanced formulations, and targeted drug delivery methods. By continuously advancing our understanding and capabilities in hormonal agents, the medical community can improve patient outcomes and quality of life for individuals with hormonal disorders.
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Technical
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Regulatory
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