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Prednisolone Hemisuccinate API Manufacturers & Suppliers

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Producer
Produced in  India
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Employees: 15

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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
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CoA

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GMP
FDA
CoA
Producer
Produced in  India
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Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
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CoA

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GMP
CoA
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Producer
Produced in  Italy
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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CoA

All certificates

GMP
CoA
Not active
Producer
Produced in  France
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Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
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CoA

All certificates

GMP
CoA
Not active
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Prednisolone hemisuccinate | CAS No: 2920-86-7 | GMP-certified suppliers

A medication that provides anti-inflammatory and immunosuppressive effects for managing inflammatory and immune-related conditions through corticosteroid activity.

Therapeutic categories

Adrenal Cortex HormonesCorticosteroidsCytochrome P-450 CYP3A InducersCytochrome P-450 CYP3A4 InducersCytochrome P-450 CYP3A4 Inducers (strength unknown)Cytochrome P-450 CYP3A5 Inducers
Generic name
Prednisolone hemisuccinate
Molecule type
small molecule
CAS number
2920-86-7
DrugBank ID
DB14633
Approval status
Experimental drug

Product Snapshot

  • Prednisolone hemisuccinate is a parenteral corticosteroid formulated as a powder for solution injectable
  • It is primarily used for its anti-inflammatory and immunosuppressive properties
  • The compound is currently experimental and lacks approval from major regulatory agencies

Clinical Overview

Prednisolone hemisuccinate is a synthetic corticosteroid classified within the glucocorticoid subgroup of adrenal cortex hormones. It belongs to the chemical classes of pregnanes and pregnadienetriols, reflecting its steroidal fused-ring structure. This compound functions as a hormone substitute and exhibits activity as a cytochrome P450 enzyme inducer, notably affecting CYP3A4 and CYP3A5 isoforms, which may influence the metabolism of concomitant medications.

As an experimental active pharmaceutical ingredient (API), prednisolone hemisuccinate is utilized primarily for its corticosteroid properties, which typically involve anti-inflammatory and immunosuppressive effects. However, specific clinical indications for this hemisuccinate ester are not established in the available data.

The mechanism of action of prednisolone derivatives generally involves modulation of glucocorticoid receptors, leading to altered gene transcription and suppression of inflammatory cytokines. Despite the absence of detailed pharmacodynamics for the hemisuccinate form, it is expected to act similarly by exerting regulatory effects on immune responses and inflammatory pathways.

Pharmacokinetic parameters such as absorption, distribution, metabolism, and excretion (ADME) characteristics are not explicitly documented for prednisolone hemisuccinate. However, as a hemisuccinate ester, it is typically formulated to enhance aqueous solubility and improve systemic bioavailability upon administration compared to the parent prednisolone compound.

Safety and toxicity profiles of prednisolone hemisuccinate have not been delineated independently; nonetheless, corticosteroids broadly carry risks of immunosuppression, hypothalamic-pituitary-adrenal axis suppression, and metabolic disturbances, necessitating careful evaluation during drug development and clinical use.

Prednisolone hemisuccinate has no widely recognized brand names, reflecting its current status as an experimental API rather than an approved pharmaceutical ingredient.

For formulation scientists and procurement professionals, sourcing prednisolone hemisuccinate requires attention to stringent quality standards, including compliance with regulatory guidelines for corticosteroid APIs. Manufacturers should provide comprehensive certificates of analysis (CoA), certificates of suitability (CEP), and ensure the absence of impurities that could affect safety or efficacy. Reliable supply chains and validated manufacturing processes are critical to maintain consistent quality, given the compound’s enzymatic induction potential and sensitivity to degradation.

Identification & chemistry

Generic name Prednisolone hemisuccinate
Molecule type Small molecule
CAS 2920-86-7
UNII G7080T74ON
DrugBank ID DB14633

Formulation & handling

  • Prednisolone hemisuccinate is a small molecule corticosteroid intended for parenteral administration as an injectable powder for solution.
  • Its moderate water solubility (0.0483 g/L) and LogP (1.54) suggest formulation strategies should balance limited aqueous solubility with adequate bioavailability upon injection.
  • Handling should focus on maintaining the powder's stability, avoiding moisture exposure to prevent hydrolysis prior to reconstitution.

Regulatory status

Prednisolone Hemisuccinate 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.


Prednisolone Hemisuccinate (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.



Prednisolone Hemisuccinate API manufacturers & distributors

Compare qualified Prednisolone Hemisuccinate API suppliers worldwide. We currently have 4 companies offering Prednisolone Hemisuccinate API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.

SupplierTypeCountryProduct originCertificationsPortfolio
Producer
India India CoA, FDA, GMP34 products
Producer
France France CoA, GMP93 products
Producer
Italy Italy CoA, GMP47 products
Producer
India India CoA, GMP50 products

When sending a request, specify which Prednisolone Hemisuccinate 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 Prednisolone Hemisuccinate 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.