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Hydrocortisone | CAS No: 50-23-7 | GMP-certified suppliers
A medication that addresses diverse inflammatory, allergic, dermatologic, gastrointestinal, and endocrine conditions, supporting treatment of ulcerative colitis, dermatoses, and pediatric adrenocortical insufficiency.
Therapeutic categories
Primary indications
- Otic solutions are indicated for infections of the external auditory canal caused by susceptible organisms and with inflammation
- Hydrocortisone tablets are indicated for certain endocrine, rheumatic, collagen, allergic, ophthalmic, respiratory, hematologic, neoplastic, edematous, gastrointestinal, and other conditions
- A hydrocortisone enema is indicated for ulcerative colitis,a topical ointment with antibiotics is indicated for corticosteroid responsive dermatoses with infections,and a topical cream with [acyclovir] is indicated to treat cold sores
- Oral granules of hydrocortisone are used as a replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age
Product Snapshot
- Hydrocortisone is available as oral small‑molecule tablets and granules, parenteral injections, rectal formulations, otic solutions, and multiple topical dermatologic forms
- It is used for broad corticosteroid indications including inflammatory, allergic, endocrine, infectious otic, dermatologic, gastrointestinal, and respiratory conditions
- It is approved for human and veterinary use in major regulated markets including the US, EU, and Canada
Clinical Overview
Pharmacologically, hydrocortisone acts as an agonist of the glucocorticoid receptor. Receptor binding suppresses phospholipase A2 activity, decreases NF‑kappa B signaling, and modulates additional transcription factors involved in inflammatory pathways. These actions reduce vasodilation, capillary permeability, and leukocyte trafficking in the short term. Over hours to days, glucocorticoid‑mediated changes in gene expression promote anti‑inflammatory proteins such as interleukin‑10 and suppress pro‑inflammatory mediators. Lower systemic doses primarily exert anti‑inflammatory effects, whereas higher doses result in broader immunosuppression. With prolonged high exposure, hydrocortisone can also bind the mineralocorticoid receptor, leading to sodium retention and potassium loss.
Hydrocortisone demonstrates a moderate duration of action and a wide therapeutic index. It is a substrate of CYP3A enzymes and P‑glycoprotein and is also reported to induce multiple CYP450 isoforms. These properties contribute to interaction potential with other agents metabolized through the same pathways. Absorption and clearance characteristics vary by route, with topical and otic products designed for localized activity and limited systemic uptake. Patients who experience irritation or sensitization are advised to discontinue treatment.
Safety considerations include dose‑dependent metabolic, endocrine, and electrolyte effects, with heightened risk during chronic systemic use. Formulation scientists should manage local tolerability, excipient compatibility, and stability of the steroid backbone.
For API procurement, sourcing should prioritize compliant manufacturing, control of related steroids and degradants, and confirmation of identity and potency using validated chromatographic methods.
Identification & chemistry
| Generic name | Hydrocortisone |
|---|---|
| Molecule type | Small molecule |
| CAS | 50-23-7 |
| UNII | WI4X0X7BPJ |
| DrugBank ID | DB00741 |
Pharmacology
| Summary | Hydrocortisone is a glucocorticoid that binds the glucocorticoid receptor to modulate gene expression and suppress pro‑inflammatory signaling pathways. Its activity includes inhibition of phospholipase A2 and NF‑kappa B, reduced leukocyte migration, and promotion of anti‑inflammatory mediators such as annexin A1. At higher systemic exposures, it can also produce broader immunosuppressive and mineralocorticoid effects. |
|---|---|
| Mechanism of action | The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation.Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days. Glucocorticoids inhibit neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote anti-inflammatory genes like interleukin-10. Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive.High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels. |
| Pharmacodynamics | Hydrocortisone binds to the glucocorticoid receptor leading to downstream effects such as inhibition of phospholipase A2, NF-kappa B, other inflammatory transcription factors, and the promotion of anti-inflammatory genes.Hydrocortisone has a wide therapeutic indexand a moderate duration of action.Patients should stop taking the medication if irritation or sensitization occurs. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Glucocorticoid receptor | Humans | agonist |
| Annexin A1 | Humans | agonist |
ADME / PK
| Absorption | Oral hydrocortisone at a dose of 0.2-0.3mg/kg/day reached a mean C<sub>max</sub> of 32.69nmol/L with a mean AUC of 90.63h\*nmol/LA 0.4-0.6mg/kg/day dose reached a mean C<sub>max</sub> of 70.81nmol/L with a mean AUC of 199.11h\*nmol/L.However, the pharmacokinetics of hydrocortisone can vary by 10 times from patient to patient. Topical hydrocortisone cream is 4-19% bioavailablewith a T<sub>max</sub> of 24h. Hydrocortisone retention enemas are have a bioavailability of 0.810 for slow absorbers and 0.502 in rapid absorbers.Slow absorbers take up hydrocortisone at a rate of 0.361±0.255/h while fast absorbers take up hydrocortisone at a rate of 1.05±0.255/h. A 20mg IV dose of hydrocortisone has an AUC of 1163±277ng\*h/mL. |
|---|---|
| Half-life | Total hydrocortisone via the oral route has a half life of 2.15h while the free fraction has a half life of 1.39h.A 20mg IV dose of hydrocortisone has a terminal half life of 1.9±0.4h. |
| Protein binding | Corticosteroids are generally bound to corticosteroid binding globulinand serum albuminin plasma. Hydrocortisone is 90.1% bound to proteins in plasma, with 56.2% bound to albumin. |
| Metabolism | Hydrocortisone is metabolised to 6-beta hydrocortisol via CYP3A, 5-beta tetrahydrocortisol via 3-oxo-5-beta-steroid 4-dehydrogenase, 5-alpha tetrahydrocortisol via 3-oxo-5-alpha-steroid 4-dehydrogenase 2, cortisone via Corticosteroid 11-beta-dehydrogenase isozyme 1 and Corticosteroid 11-beta-dehydrogenase isozyme 2, and glucuronide products.Cortisone is further metabolized to tetrahydrocortisone and dihydrocortisol. |
| Route of elimination | Corticosteroids are eliminated predominantly in the urine.However, data regarding the exact proportion is not readily available. |
| Volume of distribution | Total hydrocortisone has a volume of distribution of 39.82L, while the free fraction has a volume of distribution of 474.38L. |
| Clearance | Total hydrocortisone by the oral route has a mean clearance of 12.85L/h, while the free fraction has a mean clearance of 235.78L/h.A 20mg IV dose of hydrocortisone has a clearance of 18.2±4.2L/h. |
Formulation & handling
- Hydrocortisone is a small‑molecule corticosteroid suitable for oral, topical, ophthalmic, otic, rectal, and parenteral formulations, with solubility limitations that may require solubilizers for aqueous products.
- Low aqueous solubility and moderate polarity support use of suspensions, emulsions, or lipid‑containing vehicles for topical and injectable formulations.
- The solid API is chemically stable under standard handling, but aqueous solutions benefit from protection from oxidation and controlled pH to limit degradation.
Regulatory status
| Lifecycle | The API is in a late‑stage lifecycle, with most foundational U.S. patents expired and the remaining protections scheduled to end by early 2025 and late 2026. With established availability in the US, EU, and Canada, the market reflects a mature competitive environment. |
|---|
| Markets | US, EU, Canada |
|---|
Supply Chain
| Supply chain summary | Hydrocortisone is supplied by a large number of manufacturers and packagers, reflecting a mature landscape with no single dominant originator and extensive generic production capacity. Branded and combination products are available across the US, EU, and Canada, indicating broad global market penetration. Most core patents have expired, and the remaining formulation‑related patents nearing expiry suggest that generic competition is already well established and may expand further. |
|---|
Safety
| Toxicity | Data regarding acute overdoses of glucocorticoids are rare.Chronic high doses of glucocorticoids can lead to the development of cataract, glaucoma, hypertension, water retention, hyperlipidemia, peptic ulcer, pancreatitis, myopathy, osteoporosis, mood changes, psychosis, dermal atrophy, allergy, acne, hypertrichosis, immune suppression, decreased resistance to infection, moon face, hyperglycemia, hypocalcemia, hypophosphatemia, metabolic acidosis, growth suppression, and secondary adrenal insufficiency.Overdose may be treated by adjusting the dose or stopping the corticosteroid as well as initiating symptomatic and supportive treatment. |
|---|
- Chronic high‑dose exposure is associated with systemic corticosteroid toxicity, including ocular effects (cataract, glaucoma), metabolic disturbances (hyperglycemia, dyslipidemia, electrolyte shifts), and musculoskeletal degradation (myopathy, osteoporosis)
- Prolonged use may induce immunosuppression and reduced infection resistance, increasing the risk of secondary infections and impaired wound response
- Extended high‑level exposure can disrupt endocrine function, leading to growth suppression and secondary adrenal insufficiency
Hydrocortisone is a type of Corticosteroids
Corticosteroids are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in the field of medicine. These synthetic drugs mimic the effects of hormones naturally produced by the adrenal glands. Corticosteroids exhibit potent anti-inflammatory and immunosuppressive properties, making them widely used in the treatment of various medical conditions.
The main therapeutic applications of corticosteroids include the management of inflammatory disorders such as asthma, rheumatoid arthritis, and dermatological conditions like eczema and psoriasis. They are also employed in the treatment of allergic reactions, organ transplantations, and certain types of cancer.
Corticosteroids function by inhibiting the production of inflammatory mediators and suppressing immune responses. They act on specific receptors present in cells throughout the body, modulating gene expression and influencing various metabolic processes. These APIs are available in various formulations, including oral tablets, injectables, inhalers, nasal sprays, and topical creams.
It is crucial to note that corticosteroids must be prescribed and used under medical supervision due to their potential side effects, which can include adrenal suppression, osteoporosis, increased susceptibility to infections, and glucose intolerance. The dosage and duration of treatment vary depending on the condition being treated, and physicians carefully monitor patients to minimize any adverse effects.
In summary, corticosteroids are a vital class of pharmaceutical APIs with powerful anti-inflammatory and immunosuppressive properties. They are extensively used in the treatment of diverse medical conditions, providing relief to patients worldwide. However, their usage requires careful consideration and medical supervision to ensure optimal outcomes and minimize potential risks.
Hydrocortisone (Corticosteroids), classified under Respiratory Tract Agents
Respiratory Tract Agents are a vital category of pharmaceutical APIs (Active Pharmaceutical Ingredients) designed to treat respiratory conditions and diseases. These agents are specifically formulated to target the respiratory system, which includes the lungs, airways, and nasal passages. They play a crucial role in managing various respiratory disorders, such as asthma, chronic obstructive pulmonary disease (COPD), and allergic rhinitis.
Respiratory Tract Agents encompass a wide range of medications, including bronchodilators, corticosteroids, antihistamines, and mucolytics. Bronchodilators are commonly used to relieve airway constriction and facilitate smooth breathing by relaxing the muscles in the airways. Corticosteroids help reduce inflammation in the respiratory system, alleviating symptoms and preventing exacerbations. Antihistamines work by blocking histamine receptors, thus mitigating allergic reactions that often impact the respiratory tract. Mucolytics aid in loosening and thinning mucus, making it easier to expel from the airways.
These APIs are developed through rigorous research and development processes, ensuring their efficacy, safety, and compliance with regulatory standards. Pharmaceutical manufacturers rely on advanced technologies and stringent quality control measures to produce high-quality Respiratory Tract Agents. These APIs are subsequently incorporated into various dosage forms, including inhalers, nasal sprays, nebulizers, and oral medications.
Respiratory Tract Agents are essential in the management of respiratory conditions, providing relief from symptoms, improving lung function, and enhancing the overall quality of life for patients. They are prescribed by healthcare professionals and often used in combination therapies to achieve optimal results. As respiratory disorders continue to affect a significant portion of the global population, the development and availability of effective Respiratory Tract Agents play a vital role in addressing these health challenges and improving patient outcomes.
Hydrocortisone API manufacturers & distributors
Compare qualified Hydrocortisone API suppliers worldwide. We currently have 28 companies offering Hydrocortisone API, with manufacturing taking place in 8 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Air Products | Producer | France | Poland | CoA, GMP | 4 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 176 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | China | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Cerata Pharmaceuticals LL... | Producer | India | India | CoA, FDA, GMP | 34 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, USDMF | 252 products |
| Curia | Producer | United States | Spain | CEP, CoA, EDMF/ASMF, GMP, MSDS, USDMF | 106 products |
| Duchefa Farma B.V. | Distributor | Netherlands | United States | CoA, GMP, ISO9001, MSDS, WC | 170 products |
| Envee Drugs Pvt Ltd | Producer | India | India | CoA, GMP, ISO9001 | 16 products |
| Henan Lihua | Producer | China | China | CoA, JDMF, USDMF | 7 products |
| Hokko Chemical Industry | Producer | Japan | Japan | CoA, JDMF | 2 products |
| Jiangsu Jiaerke | Producer | China | China | CoA | 11 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
| Mac Chem Products | Producer | India | India | CoA, GMP, WC | 25 products |
| Metapharmaceutical Indust... | Producer | Spain | China | BSE/TSE, CoA, GDP, GMP, MSDS, WC | 21 products |
| Pharm Rx Chemical Corp | Distributor | United States | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Pharmacia & Upjohn | Producer | United States | United States | CoA, USDMF | 30 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| Sanofi | Producer | France | Unknown | CEP, CoA, FDA, GMP, JDMF, USDMF | 93 products |
| Shandong Xinhua | Producer | China | China | CoA, USDMF, WC | 21 products |
| Shanghai New Hualian | Producer | China | China | CoA, USDMF | 2 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF | 762 products |
| Symbiotec Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 50 products |
| Tianjin Jinjin | Producer | China | China | CoA, USDMF | 12 products |
| Tianjin Tianmao | Producer | China | China | CoA | 6 products |
| Zhejiang Xianju | Producer | China | China | CoA, USDMF | 17 products |
When sending a request, specify which Hydrocortisone API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Hydrocortisone API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Hydrocortisone API
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Technical
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Regulatory
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