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Betamethasone | CAS No: 378-44-9 | GMP-certified suppliers
A medication that manages inflammatory skin conditions and plaque psoriasis and supports systemic treatment of diverse endocrine, rheumatic, gastrointestinal, and other inflammatory disorders.
Therapeutic categories
Primary indications
- As a member of the corticosteroid family, betamethasone is indicated for the treatment of several inflammatory conditions
- As topical monotherapy, betamethasone is indicated to relieve pruritic and inflammatory symptoms of corticosteroid-responsive-dermatoses
- Betamethasone can be used topically in combination with a vitamin D analog such as calcipotriene to treat plaque psoriasis
- The corticosteroid is also available as an injectable suspension and can be used to manage a range of inflammatory conditions including endocrine disorders, gastrointestinal disorders, and rheumatic disorders among other conditions
Product Snapshot
- Betamethasone is a synthetic small-molecule corticosteroid supplied in multiple topical formulations and parenteral suspensions/solutions
- It is used for corticosteroid‑responsive inflammatory dermatoses and for systemic management of diverse inflammatory and endocrine conditions
- It is approved for human and veterinary use in the US and Canada
Clinical Overview
Pharmacologically, betamethasone suppresses pro‑inflammatory signaling by binding to the glucocorticoid receptor. This interaction reduces transcription of inflammatory mediators and enhances transcription of anti‑inflammatory genes. Pharmacodynamic effects include inhibition of NF‑kappa B and other transcription factors, reduced phospholipase A2 activity, and decreased formation of arachidonic acid derivatives. Betamethasone also modulates neutrophil apoptosis and demargination. Its actions occur through both genomic pathways, which lead to slower transcriptional changes, and nongenomic pathways that mediate rapid cellular responses via membrane‑associated receptors.
Absorption and distribution characteristics vary by formulation; topical products have limited systemic exposure when used appropriately, while parenteral administration provides higher systemic availability. Betamethasone is a substrate of CYP3A enzymes and may act as an inducer of several cytochrome P450 isoforms, creating potential for clinically relevant metabolic interactions. Elimination occurs primarily through hepatic metabolism and subsequent renal excretion of metabolites.
Safety considerations include hypothalamic–pituitary–adrenal axis suppression with prolonged or high‑dose exposure, increased susceptibility to infection, and potential systemic effects with misuse of topical formulations. Long‑acting systemic use requires attention to glycemic control, bone health, and withdrawal tapering. Local adverse reactions such as skin atrophy may occur with chronic topical application.
Widely used brands vary by region and include monotherapy corticosteroid creams, combination dermatologic preparations, and injectable suspensions for systemic use. For API procurement, sourcing should prioritize compliance with pharmacopeial standards, validated impurity profiles, and robust supply chain traceability to support regulatory submissions and formulation development.
Identification & chemistry
| Generic name | Betamethasone |
|---|---|
| Molecule type | Small molecule |
| CAS | 378-44-9 |
| UNII | 9842X06Q6M |
| DrugBank ID | DB00443 |
Pharmacology
| Summary | Betamethasone is a glucocorticoid that binds the glucocorticoid receptor to suppress pro‑inflammatory transcription factors such as NF‑κB and reduce synthesis of arachidonic acid–derived mediators. It promotes transcription of anti‑inflammatory genes through genomic signaling and also exerts rapid nongenomic effects via membrane-associated pathways. The net pharmacodynamic effect is broad modulation of immune and inflammatory activity for corticosteroid‑responsive conditions. |
|---|---|
| Mechanism of action | Glucocorticoids inhibit neutrophil apoptosis and demargination, and inhibit NF-Kappa B and other inflammatory transcription factors.They also inhibit phospholipase A2, leading to decreased formation of arachidonic acid derivatives.In addition, glucocorticoids promote anti-inflammatory genes like interleukin-10. Corticosteroids like betamethasone can act through nongenomic and genomic pathways.The genomic pathway is slower and occurs when glucocorticoids activate glucocorticoid receptors and initiate downstream effects that promote transcription of anti-inflammatory genes including phosphoenolpyruvate carboxykinase (PEPCK), IL-1-receptor antagonist, and tyrosine amino transferase (TAT).On the other hand, the nongenomic pathway is able to elicit a quicker response by modulating T-cell, platelet and monocyte activity through the use of existing membrane-bound receptors and second messengers. |
| Pharmacodynamics | Corticosteroids bind to the glucocorticoid receptor inhibiting pro-inflammatory signals, while promoting anti-inflammatory signals.Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces.Patients who require long-term treatment with a corticosteroid 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 | The absorption and potency of any topical corticosteroid including betamethasone depends on the vehicle in which the steroid is delivered. For example, betamethasone dipropionate 0.05% ointment is classified as a highly potent topical steroid, while betamethasone dipropionate 0.05% cream or lotion is considered to be moderately potent. There are several structural modifications that can determine the potency of a topical corticosteroid. For example, corticosteroids containing a halogen at specific carbons, or that contain esters are more potent due to enhanced lipophilicity.As such, there is a marked difference between topical products containing betamethasone dipropionate vs. betamethasone valerate. Betamethasone dipropionate contains 2 esters which enhances its potency, while betamethasone valerate has only one ester and is less potent. It should be noted that the use of occlusive dressings with topical steroids significantly increases the absorption, increasing the risk for adverse effects. |
|---|---|
| Half-life | In a study that included Indian women of reproductive age, the half-life following a single intramuscular dose of betamethasone phosphate was 10.2 ± 2.5 hours. |
| Protein binding | Betamethasone valerate binds to serum albumin and corticosteroid-binding globulin. |
| Metabolism | The metabolism of betamethasone yields 6 metabolites.The metabolic processes include 6β hydroxylation, 11β-hydroxyl oxidation, and reduction of the C-20 carbonyl group followed by removal of the side chain. |
| Route of elimination | Corticosteroids are eliminated predominantly in the urine. |
| Volume of distribution | In a study that included Indian women of reproductive age, the volume of distribution following a single intramuscular dose of betamethasone phosphate was 94,584±23,539 mL(s). |
| Clearance | In a study that included Indian women of reproductive age, the CL/F following a single intramuscular dose of betamethasone phosphate was 6,466 ± 805 mL/hour. |
Formulation & handling
- Betamethasone is a small‑molecule corticosteroid with low aqueous solubility, requiring solubilizers or suspension systems for oral liquids, ophthalmic/otic drops, and parenteral formulations.
- Topical, nasal, and cutaneous products leverage its lipophilicity for dermal penetration, with stability supported by semi-solid or emulsion bases.
- Parenteral and intra‑articular uses typically rely on sterile solutions or suspensions, with handling focused on preventing particulate formation and maintaining sterility.
Regulatory status
| Lifecycle | Most U.S. patents for the API expired between 2016 and 2020, with a later‑expiring patent extending protection until 2031. In the US and Canadian markets, this mix of expired and active protection suggests a product transitioning from established generic availability toward continued limited exclusivity for any elements covered by the remaining patent. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Betamethasone has long-standing originator involvement from earlier innovator companies, with a wide shift toward numerous generic manufacturers and packagers that now dominate supply. Branded and generic products are established mainly in the US and Canada, indicating mature market availability rather than broad global expansion. Most historical patents have expired, and only one US patent extends to 2031, consistent with an environment of existing and ongoing generic competition across formulations. |
|---|
Safety
| Toxicity | Chronic high doses of glucocorticoids can lead to the development of cataracts, 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. |
|---|
- Prolonged or high‑level exposure to glucocorticoid APIs may be associated with metabolic, ocular, musculoskeletal, and neuropsychiatric toxicities, including hyperglycemia, osteoporosis, cataract formation, and mood alterations
- Chronic handling or manufacturing exposure warrants controls to limit immunosuppressive and endocrine‑disrupting effects, as the compound can suppress adrenal function and reduce infection resistance
- Material can contribute to dermal atrophy or irritation on repeated contact
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.
Betamethasone 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.
Betamethasone (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.
Betamethasone API manufacturers & distributors
Compare qualified Betamethasone API suppliers worldwide. We currently have 23 companies offering Betamethasone API, with manufacturing taking place in 10 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 |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GDP, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC, WHO-GMP | 176 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Cerata Pharmaceuticals LL... | Producer | India | India | CoA, FDA, GMP, WHO-GMP | 34 products |
| Chemical Dojin Co | Producer | Japan | Japan | CoA, JDMF | 1 products |
| Curia | Producer | United States | Spain | CoA, GMP, MSDS | 106 products |
| Envee Drugs Pvt Ltd | Producer | India | India | CoA, GMP, ISO9001 | 16 products |
| Farmabios | Producer | Italy | Italy | CoA, ISO9001, JDMF, USDMF | 58 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Formosa Labs | Producer | Taiwan | Taiwan | CoA, JDMF | 36 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hovione Farmaciencia | Producer | Portugal | Portugal | CoA, JDMF, USDMF | 16 products |
| Hunan Yuxin Pharmaceutica... | Producer | China | China | CoA, GMP, USDMF, WC | 14 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Nanjing Bolka | Producer | China | China | CoA | 8 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sicor | Producer | Italy | Italy | CoA, GMP | 47 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 762 products |
| Sogo Pharmaceutical | Producer | Japan | Japan | CoA, JDMF | 5 products |
| Symbiotec Pharma | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 50 products |
| Tianjin Tianmao | Producer | China | China | CoA | 6 products |
| Tianjin Tianyao | Producer | China | China | CoA, USDMF | 24 products |
When sending a request, specify which Betamethasone 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 Betamethasone 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 Betamethasone API
Sourcing
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Technical
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How does Betamethasone work?
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Is Betamethasone a small molecule?
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Regulatory
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