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Prednisone | CAS No: 53-03-2 | GMP-certified suppliers
A medication that provides broad anti-inflammatory and immunosuppressive support for allergic, respiratory, dermatologic, rheumatologic, gastrointestinal, hematologic, and transplant-related conditions.
Therapeutic categories
Primary indications
- Prednisone is indicated as an anti-inflammatory or immunosuppressive drug for allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, infectious, endocrine, or neoplastic conditions as well as in organ transplant
Product Snapshot
- Prednisone is an oral small‑molecule corticosteroid supplied primarily in multiple tablet presentations
- It is used for broad anti‑inflammatory and immunosuppressive applications across allergic, autoimmune, hematologic, respiratory, and transplant settings
- It is approved for human and veterinary use in the US and Canada
Clinical Overview
Following conversion, prednisolone binds to the glucocorticoid receptor, producing dose‑dependent anti‑inflammatory and immunosuppressive effects. Early pharmacologic actions include reduced vasodilation and capillary permeability and diminished leukocyte trafficking. Glucocorticoid receptor activation also modulates gene transcription, contributing to sustained downstream effects. Key pathways influenced include inhibition of phospholipase A2, suppression of arachidonic acid derivative synthesis, blockade of NF‑kappa B and related transcription factors, and enhancement of anti‑inflammatory mediators such as interleukin‑10. Lower doses primarily exert anti‑inflammatory activity, while higher doses achieve broader immunosuppression. With prolonged high exposure, binding at mineralocorticoid receptors may increase sodium retention and reduce potassium levels.
Prednisone exhibits a short plasma half‑life of approximately 2 to 3 hours. Absorption is generally reliable after oral administration, with hepatic metabolism serving as the activation step. Clearance is primarily renal as metabolites. It is both a substrate and inducer of several cytochrome P450 isoenzymes and interacts with P‑glycoprotein transport processes, factors that may influence drug–drug interaction risk.
Safety considerations include hypothalamic–pituitary–adrenal axis suppression, increased susceptibility to infection, and metabolic effects typical of systemic corticosteroids. Long‑term exposure warrants careful monitoring of electrolyte balance, glucose regulation, and immunologic status. Prednisone is widely marketed globally, commonly in generic formulations.
For API procurement, sourcing should prioritize verified synthesis pathways, documented impurity profiles, and compliance with pharmacopoeial monographs to support consistent quality and regulatory acceptance.
Identification & chemistry
| Generic name | Prednisone |
|---|---|
| Molecule type | Small molecule |
| CAS | 53-03-2 |
| UNII | VB0R961HZT |
| DrugBank ID | DB00635 |
Pharmacology
| Summary | Prednisone is converted to prednisolone, which acts as a glucocorticoid receptor agonist to modulate inflammatory and immune responses. By altering gene transcription, it suppresses pro‑inflammatory pathways such as NF‑κB signaling and reduces production of arachidonic acid derivatives while promoting anti‑inflammatory mediators. At higher exposure levels, its activity extends to broader immunosuppressive effects. |
|---|---|
| Mechanism of action | Prednisone is first metabolized in the liver to its active form, prednisolone, a glucocorticoid agonist corticosteroid. 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 | Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals.Prednisone has a short duration of action as the half life is 2-3 hours.Corticosteroids have a wide therapeutic window as patients make require doses that are multiples of what the body naturally produces.Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Glucocorticoid receptor | Humans | agonist |
ADME / PK
| Absorption | Oral prednisone has a T<sub>max</sub> of 2 hours, while the delayed-release formulation has a T<sub>max</sub> of 6-6.5 hours.A 5mg dose of prednisone has an AUC of 572mL/min/1.73m<sup>2</sup>, a 20mg dose of prednisone has an AUC of 1034mL/min/1.73m<sup>2</sup>, and a 50mg dose of prednisone has an AUC of 2271mL/min/1.73m<sup>2</sup>.Data regarding the C<sub>max</sub> of prednisone is not readily available. |
|---|---|
| Half-life | Prednisone and its active metabolite [prednisolone] have half lives of 2-3 hours from both immediate and delayed release preparations. |
| Protein binding | Corticosteroids are generally bound to corticosteroid binding globulinand serum albuminin plasma. Prednisone is <50% bound to protein in plasma. |
| Metabolism | Prednisone is metabolized to 17α,21-dihydroxy-pregnan-1,4,6-trien-3,11,30-trione (M-XVII), 20α-dihydro-prednisone (M-V), 6βhydroxy-prednisone (M-XII), 6α-hydroxy-prednisone (M-XIII), or 20β-dihydro-prednisone (M-IV).20β-dihydro-prednisone is metabolized to 17α,20ξ,21-trihydroxy-5ξ-pregn-1-en-3,11-dione(M-XVIII).Prednison is reversibly metabolized to [prednisolone].Prednisolone is metabolized to Δ6-prednisolone (M-XI), 20α-dihydro-prednisolone (M-III), 20β-dihydro-prednisolone (M-II), 6αhydroxy-prednisolone (M-VII), or 6βhydroxy-prednisolone(M-VI).6αhydroxy-prednisolone is metabolized to 6α,11β,17α,20β,21-pentahydroxypregnan-1,4-diene-3-one (M-X).6βhydroxy-prednisolone is metabolized to 6β,11β,17α,20β,21-pentahydroxypregnan-1,4-diene-3-one (M-VIII), 6β,11β,17α,20α,21-pentahydroxypregnan-1,4-diene-3-one (M-IX), and 6β,11β,17α,21-tetrahydroxy-5ξ-pregn-1-en-3,20-dione (M-XIV).MVIII is metabolized to 6β,11β,17α,20β,21-pentahydroxy-5ξ-pregn-1-en-3-one (M-XV) and then to MXIV, while MIX is metabolized to 6β,11β,17α,20α,21-pentahydroxy-5ξ-pregn-1-en-3-one (M-XVI) and then to MXIV.These metabolites and their glucuronide conjugates are excreted predominantly in the urine. |
| Route of elimination | Prednisone is excreted mainly in the urine as sulfate and glucuronide conjugates. |
| Volume of distribution | Data regarding the volume of distribution for prednisone is not readily available.However, a 0.15mg/kg dose of prednisolone has a volume of distribution of 29.3L, while a 0.30mg/kg dose has a volume of distribution of 44.2L. |
| Clearance | Data regarding the clearance of prednisone is not readily available. A 5.5µg/h/kg infusion of prednisolone has an average clearance of 0.066±0.12L/h/kg, while a 0.15±0.03L/h/kg infusion has an average clearance of 0.15L/h/kg. |
Formulation & handling
- Oral small‑molecule corticosteroid suitable for conventional tablets, solutions, and delayed‑release formats with no parenteral formulation constraints.
- Moderate lipophilicity (LogP ~1.7) supports good oral absorption; co-administration with food is used mainly to reduce gastric irritation rather than to affect bioavailability.
- Solid-state stability is generally good, with standard protection from moisture and light recommended for tablet and solution manufacturing.
Regulatory status
| Lifecycle | Most U.S. patents covering the API expire in 2024, with one extending protection to early 2028, indicating a transition toward later‑stage exclusivity. With commercialization limited to the United States and Canada, the product is approaching a mature market phase as key protections near expiry. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Prednisone originated with a small group of early developers, but the current supply landscape is dominated by a large number of generic manufacturers and repackagers. Branded and generic products are widely established in the US and Canada, with long-standing availability across multiple dose forms. Most listed US patents have expired or will expire shortly, indicating that generic competition is already mature and not meaningfully constrained by remaining protections. |
|---|
Safety
| Toxicity | Data regarding acute overdoses of prednisone are rare but prolonged high doses of prednisone can lead to a higher incidence and severity of adverse effects such as mental symptoms, moon face, abnormal fat deposits, fluid retention, excessive appetite, weight gain, hypertrichosis, acne, striae, ecchymosis, increased sweating, pigmentation, dry scaly skin, thinning scalp hair, increased blood pressure, tachycardia, thrombophlebitis, decreased resistance to infection, negative nitrogen balance with delayed bone and wound healing, headache, weakness, menstrual disorders, accentuated menopausal symptoms, neuropathy, fractures, osteoporosis, peptic ulcer, decreased glucose tolerance, hypokalemia, and adrenal insufficiency. |
|---|
- Prolonged or high‑dose exposure is associated with metabolic and endocrine disturbances, including fluid retention, hypertension, altered glucose tolerance, and risk of adrenal suppression
- Chronic handling or manufacturing exposure may correlate with dermatologic and musculoskeletal effects such as skin atrophy, delayed wound healing, and potential contribution to bone demineralization
- Systemic toxicity profiles note increased susceptibility to infection and neuropsychiatric reactions, highlighting the need for controlled environments and appropriate industrial containment measures
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Prednisone 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.
Prednisone (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.
Prednisone API manufacturers & distributors
Compare qualified Prednisone API suppliers worldwide. We currently have 11 companies offering Prednisone API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| 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 |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, USDMF | 252 products |
| Henan Lihua | Producer | China | China | CEP, CoA, FDA, GMP, USDMF | 7 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Pharmacia & Upjohn | Producer | United States | United States | CEP, CoA, FDA, GMP | 30 products |
| Sanofi | Producer | France | Unknown | CoA, GMP, USDMF | 93 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 757 products |
| Tianjin Jinjin | Producer | China | China | CoA, GMP | 12 products |
| Tianjin Tianyao | Producer | China | China | CEP, CoA, FDA, USDMF | 24 products |
| Zhejiang Xianju | Producer | China | China | CEP, CoA, GMP, USDMF | 17 products |
When sending a request, specify which Prednisone 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 Prednisone 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 Prednisone API
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Technical
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Regulatory
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