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Fluocinolone acetonide | CAS No: 67-73-2 | GMP-certified suppliers
A medication that provides corticosteroid relief for inflammatory skin conditions, seborrheic dermatitis, chronic eczematous otitis, and supports ophthalmic treatment of diabetic macular edema and non‑infectious uveitis.
Therapeutic categories
Primary indications
- Fluocinolone acetonide has been used extensively in different medical areas
- In dermatology, it is extensively used for the relief of inflammatory dermatosis, dermatitis, psoriasis, hypertrophic tissues, keloid tissues and atopic dermatitis
- It has been used in shampoo products as a low to medium potency corticosteroid for the treatment of seborrheic dermatitis of the scalp
Product Snapshot
- Fluocinolone acetonide is supplied as topical dermatologic products, otic solutions, shampoos, and intravitreal implants
- It is used for inflammatory dermatoses, seborrheic dermatitis, chronic eczematous external otitis, and ocular inflammatory conditions such as diabetic macular edema and non‑infectious posterior uveitis
- It is approved in the US and Canada, including FDA approval for specific ophthalmic indications, with additional investigational and veterinary statuses
Clinical Overview
Pharmacologically, fluocinolone acetonide exerts anti‑inflammatory and immunosuppressive effects through vasoconstriction and suppression of vascular permeability, leukocyte recruitment, fibroblast proliferation, and collagen deposition. Clinical experience with intravitreal micro‑inserts shows reduced uveitis flare frequency, with intraocular pressure increases requiring monitoring.
The mechanism of action involves high‑affinity binding to the glucocorticoid receptor, followed by nuclear translocation of the ligand‑receptor complex and modulation of glucocorticoid response elements. This induces phospholipase A2 inhibitory proteins such as annexin 1, limiting arachidonic acid release and downstream production of prostaglandins and leukotrienes. These actions collectively reduce edema, fibrin deposition, capillary dilation, and scar formation.
Absorption and disposition depend on route. Topical use generally results in limited systemic exposure unless applied to large or compromised skin surfaces. Intravitreal implants provide localized, sustained delivery. Fluocinolone acetonide is a CYP3A4 substrate and can act as an inducer, necessitating awareness of metabolic interactions.
Safety considerations include potential local atrophy with topical overuse, hypothalamic‑pituitary‑adrenal axis suppression with extensive exposure, and intraocular pressure elevation with ophthalmic implants.
For API procurement, sourcing should prioritize consistent polymorph, impurity control, and verification of fluorinated steroid identity to ensure suitability for topical or implantable formulations.
Identification & chemistry
| Generic name | Fluocinolone acetonide |
|---|---|
| Molecule type | Small molecule |
| CAS | 67-73-2 |
| UNII | 0CD5FD6S2M |
| DrugBank ID | DB00591 |
Pharmacology
| Summary | Fluocinolone acetonide is a synthetic corticosteroid that binds the glucocorticoid receptor, forming a complex that regulates gene transcription linked to inflammatory control. This interaction induces lipocortin proteins, which inhibit phospholipase A2 and reduce production of arachidonic‑acid–derived mediators such as prostaglandins and leukotrienes. The resulting pharmacodynamic profile includes suppression of inflammatory signaling, immune activity, and vascular permeability. |
|---|---|
| Mechanism of action | Fluocinolone acetonide is a corticosteroid and thus, it can be inferred that it acts by inhibiting the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, collagen deposition, and scar formation. Some reports have indicated that fluocinolone acetonide presents a high binding affinity for the glucocorticoid receptor. After binding the receptor, the newly formed receptor-ligand complex translocates itself into the cell nucleus, where it binds to many glucocorticoid response elements in the promoter region of the target genes.This effect promotes the induction of phospholipase A2 inhibitory proteins (lipocortins). Through this mechanism of action, it is thought that fluocinolone induces mainly one of the lipocortins, annexin 1, which will later mediate the synthesis of inflammatory mediators such as prostaglandins and leukotrienes by inhibiting the release of arachidonic acid which is the precursor of all these inflammatory mediators. Hence, the induction of these proteins will prevent the release of arachidonic acid by phospholipase A2. |
| Pharmacodynamics | Fluocinolone acetonide is a synthetic anti-inflammatory corticosteroid and thus, the effect of its interaction with the body produces vasoconstriction and suppression of membrane permeability, mitotic activity, immune response and release of inflammatory mediators. For its ophthalmic indications, fluocinolone acetonide is administered as intravitreal micro-insert. This preparation was observed in clinical trials to reduce the recurrence of uveitis flares by 2 fold when compared with the non treated patients even after six months after initial administration. As well the intraocular pressure seemed to increase slightly with the presence of the fluocinolone implant but it is important to monitor intraocular pressure. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Glucocorticoid receptor | Humans | agonist |
| Annexin A1 | Humans | inducer |
| Annexin A2 | Humans | inducer |
ADME / PK
| Absorption | When administered as an eye implant, fluocinolone acetonide presents a sustained delivery for even 12 months in which there can be observed a sustained release.The concentration of fluocinolone acetonide are generally higher in the vitreous and retina with a little dispersion to the aqueous humor. There are reports indicating that topical administration of fluocinolone acetonide produces a percutaneous absorption which is determined by the vehicle, integrity of the epidermal barrier and the use of occlusive dressing. Independently of the route of administration, the systemic absorption of fluocinolone acetonide is below 0.1 ng/ml which indicates that the systemic distribution is very minimal and the effect of fluocinolone is mainly local. |
|---|---|
| Half-life | The reported half-life of fluocinolone acetonide ranges between 1.3-1.7 hours. |
| Protein binding | This pharmacokinetic parameter is not relevant as the systemic absorption of fluocinolone acetonide is very minimal. |
| Metabolism | Following absorption, fluocinolone acetonide metabolism is primarily hepatic.It is important to mention that the systemically absorbed dose is very minimal. |
| Route of elimination | Fluocinolone acetonide is mainly excreted by the kidneys.It is important to mention that the systemically absorbed dose is very minimal. |
| Volume of distribution | This pharmacokinetic parameter is not relevant as the systemic absorption of fluocinolone acetonide is very minimal. |
| Clearance | This pharmacokinetic parameter is not relevant as the systemic absorption of fluocinolone acetonide is very minimal and the concentration in urine is lower than the minimum quantitation limit. |
Formulation & handling
- Topical, otic, nasal, rectal, and intravitreal routes rely on local delivery; the API’s low aqueous solubility favors use of emulsions, oils, or solvent‑based solutions for adequate dispersion.
- As a solid, lipophilic corticosteroid, it typically requires solubilizers or occlusive bases to enhance skin or mucosal penetration and maintain uniformity in semisolid dosage forms.
- Intravitreal and intraocular implants depend on controlled‑release polymers to stabilize the molecule and modulate its slow, localized delivery.
Regulatory status
| Lifecycle | Most U.S. patents covering the API have already expired, with remaining protection ending in 2026, indicating a late‑stage lifecycle. With products marketed in the US and Canada, the market is largely mature and positioned for continued or expanding generic participation. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Fluocinolone acetonide is supplied by a large group of manufacturers and packagers, reflecting a mature market with multiple established producers rather than reliance on a single originator. Branded products are primarily marketed in the US and Canada, indicating a regional but well‑established commercial presence. Several key US patents have already expired, with the remaining expirations approaching mid‑decade, supporting the presence of existing generics and the likelihood of continued multisource competition. |
|---|
Safety
| Toxicity | Studies to determine the carcinogenic and its effect in fertility have not been performed. It is important to consider that several corticosteroids have been shown to present genotoxic potential but fluocinolone acetonide was shown to not be genotoxic in the Ames test and mouse lymphoma TK assay. |
|---|
- No carcinogenicity or fertility studies are available
- However, standard genotoxicity assays (Ames, mouse lymphoma TK) showed no genotoxic activity for fluocinolone acetonide
- Classified as a corticosteroid with class‑related risks of genotoxic potential, requiring controlled handling and appropriate containment during manufacturing
Fluocinolone Acetonide 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.
Fluocinolone Acetonide (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.
Fluocinolone Acetonide API manufacturers & distributors
Compare qualified Fluocinolone Acetonide API suppliers worldwide. We currently have 12 companies offering Fluocinolone Acetonide 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 |
|---|---|---|---|---|---|
| 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 | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Cambrex | Producer | Italy | United States | CoA, GMP | 104 products |
| Cerata Pharmaceuticals LL... | Producer | India | India | CoA, FDA, GMP | 34 products |
| Coral Drugs | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, ISO9001, WC, WHO-GMP | 25 products |
| Farmabios | Producer | Italy | Italy | CEP, CoA, FDA, GMP, ISO9001, JDMF, USDMF | 58 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 |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Sicor | Producer | Italy | Italy | CoA, GMP | 47 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 142 products |
When sending a request, specify which Fluocinolone Acetonide 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 Fluocinolone Acetonide 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 Fluocinolone Acetonide API
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Technical
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Regulatory
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