Corticosteroid APIs
Premium Glucocorticoid Active Pharmaceutical Ingredients for Anti-inflammatory Treatment
About Corticosteroid APIs
Holiness Pharmaceutical is a leading manufacturer and exporter of high-quality Corticosteroid APIs used in anti-inflammatory, immunosuppressive, and endocrine therapy. Our extensive portfolio includes various betamethasone derivatives, dexamethasone compounds, prednisolone, hydrocortisone, and other glucocorticoid ingredients manufactured under strict WHO-GMP guidelines for global pharmaceutical markets.
Key Features
- WHO-GMP and ISO certified manufacturing facilities
- Compliance with IP, BP, USP, and EP pharmacopeial standards
- Multiple salt forms and ester derivatives available
- Advanced crystallization and purification technology
- Polymorphic form control and characterization
- Comprehensive impurity profiling and stability studies
- Complete regulatory documentation and DMF support
- Technical support for formulation development
Application Areas
Inflammatory Diseases
Treatment of arthritis, inflammatory bowel disease, and acute inflammation
Respiratory Conditions
Management of asthma, COPD, and allergic respiratory disorders
Dermatological Disorders
Topical treatment of eczema, psoriasis, and inflammatory skin conditions
Autoimmune Diseases
Immunosuppression in lupus, rheumatoid arthritis, and organ transplants
Allergic Reactions
Acute and chronic allergic conditions management
Quality Assurance
Our corticosteroid APIs undergo rigorous quality control including HPLC purity analysis, polymorphic characterization using XRD and DSC, residual solvent testing, heavy metal analysis, and comprehensive microbiological testing. Each batch is accompanied by a detailed Certificate of Analysis ensuring compliance with international pharmacopeial standards.
Our Corticosteroid APIs Products
| Product Name | CAS Number | Grade | Form | Actions |
|---|---|---|---|---|
Betamethasone Acetate API | 987-24-6 | BP/USP/EP | API Powder | View Product |
Betamethasone Dipropionate API | 5593-20-4 | BP/USP/EP | API Powder | View Product |
Betamethasone Sodium Phosphate API | 151-73-5 | BP/USP/EP | API Powder | View Product |
Betamethasone Valerate API | 2152-44-5 | BP/USP/EP | API Powder | View Product |
Budesonide API | 51333-22-3 | BP/USP/EP | API Powder | View Product |
Clobetasol Propionate API | 25122-46-7 | IP/BP/USP | API Powder | View Product |
Deflazacort API | 14484-47-0 | BP/USP/EP | API Powder | View Product |
Dexamethasone Acetate API | 1177-87-3 | BP/USP/EP | API Powder | View Product |
Dexamethasone Sodium Phosphate API | 2392-39-4 | BP/USP/EP | API Powder | View Product |
Dutasteride API | 164656-23-9 | BP/USP/EP | API Powder | View Product |
Frequently Asked Questions
What are Corticosteroid APIs?
Corticosteroid APIs are active pharmaceutical ingredients that mimic cortisol, a natural hormone produced by adrenal glands. These synthetic glucocorticoids possess powerful anti-inflammatory and immunosuppressive properties, making them essential in treating inflammatory conditions, autoimmune diseases, allergic reactions, and respiratory disorders.
Which corticosteroid APIs does Holiness Pharmaceutical manufacture?
We manufacture a comprehensive range including Betamethasone (Acetate, Dipropionate, Sodium Phosphate, Valerate), Dexamethasone (Acetate, Sodium Phosphate), Prednisolone, Hydrocortisone (Acetate, Hemisuccinate), Budesonide, Deflazacort, Mometasone Furoate, Halobetasol Propionate, Fluocinolone Acetonide, and Spironolactone.
What is the difference between different corticosteroid salt forms?
Different salt forms offer varying properties: acetates and propionates are lipophilic for topical use, sodium phosphate is water-soluble for injections, dipropionate and valerate provide enhanced skin penetration, and esters like hemisuccinate offer improved stability. Each form is designed for specific formulation requirements and routes of administration.
How do you ensure polymorphic consistency in corticosteroid APIs?
We maintain strict control over crystallization parameters including temperature, solvent systems, and cooling rates. Each batch undergoes polymorphic characterization using X-Ray Diffraction (XRD), Differential Scanning Calorimetry (DSC), and FTIR spectroscopy to ensure consistent crystal form, which is critical for bioavailability and product stability.
What quality standards apply to your Corticosteroid APIs?
Our corticosteroid APIs comply with IP (Indian Pharmacopoeia), BP (British Pharmacopoeia), USP (United States Pharmacopeia), and EP (European Pharmacopoeia) standards. We conduct comprehensive testing including purity analysis, related substances, residual solvents, heavy metals, particle size distribution, and microbiological evaluation for each batch.
Can you provide technical support for corticosteroid formulations?
Yes, our technical team provides formulation development support including solubility data, compatibility studies with common excipients, particle size recommendations for different dosage forms, stability guidance, and assistance with topical, oral, injectable, and inhalation formulations.
What documentation do you provide with Corticosteroid APIs?
We provide comprehensive documentation including Certificate of Analysis (CoA), Drug Master Files (DMF), stability data under ICH guidelines, impurity profiles, manufacturing process flow, analytical methods, regulatory status documents, and GMP certificates. Our regulatory team supports global product registration requirements.
What is the shelf life and storage requirement for Corticosteroid APIs?
Most corticosteroid APIs have a shelf life of 2-3 years when stored properly in tightly closed containers, protected from light and moisture, at controlled room temperature (15-25°C). Specific storage requirements and retest dates are provided on product labels and Certificates of Analysis based on stability studies.