Description
Deflazacort Tablets (6 mg / 30 mg)
Healthy Inc is a specialized global supplier and exporter of advanced immunology, rheumatology, and targeted high-containment corticosteroid therapeutics. We provide ultra-high-purity, kinetically precise Deflazacort Tablets (6 mg / 30 mg), manufactured in WHO–GMP certified, strictly segregated maximum-containment (OEB 4) steroidal oral solid dosage facilities. This “Bone-Sparing Glucocorticoid Prodrug” is a massive-volume, highly strategic export to rheumatology networks, pediatric neurology centers, allergy clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally preferred, long-term intervention for severe autoimmune disorders, asthma exacerbations, and Duchenne Muscular Dystrophy (DMD).
Product Overview
This highly advanced formulation operates as a profound, systemic immune dampener. It aggressively penetrates the cell nucleus to silence the genes responsible for runaway inflammation, but it is structurally engineered to minimize the catastrophic collateral damage to bones and metabolism typically caused by long-term steroid use.
The “Bone-Sparing Prodrug & Genomic Immunosuppressant” Specialist:
- Mechanism 1 (The Prodrug Hepatic Cleavage): Deflazacort itself is an inactive oxazoline derivative of prednisolone. Upon ingestion and intestinal absorption, it is immediately routed to the liver where plasma esterases rapidly cleave it into its highly potent, active metabolite: 21-desacetyl deflazacort. This guarantees a smooth, sustained release of the active glucocorticoid into the systemic circulation.
- Mechanism 2 (Genomic Anti-Inflammatory Cascade): The active metabolite crosses cell membranes and binds to cytoplasmic glucocorticoid receptors. This complex then enters the cell nucleus, where it physically binds to DNA. It aggressively down-regulates the transcription of pro-inflammatory cytokines (like interleukins and TNF-alpha) and violently halts the proliferation of hyperactive macrophages and T-lymphocytes.
- Mechanism 3 (The Calcium & Glucose Sparing Advantage): The defining clinical superiority of Deflazacort over standard steroids is its reduced interference with calcium metabolism and carbohydrate synthesis. It causes significantly less calcium excretion in the urine, drastically reducing the risk of severe osteoporosis, and has a vastly lower diabetogenic effect, making it the safest option for patients requiring years of continuous corticosteroid therapy.
Product Composition & Strength
We supply this product as a Precision-Blended, High-Density Steroidal Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the glucocorticoid prodrug.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Deflazacort USP/Ph.Eur. | 6 mg | The Pediatric & Titration Standard: The definitive unit utilized for weight-based dosing in pediatric Duchenne Muscular Dystrophy, slow tapering protocols, and chronic low-dose maintenance for rheumatoid arthritis. |
| Deflazacort USP/Ph.Eur. | 30 mg | The Acute Flare-Up Macrodose: High-efficacy therapeutic payload utilized for the immediate, aggressive suppression of severe allergic anaphylaxis, acute asthma exacerbations, and violent autoimmune flare-ups. |
| Excipients | Lactose Monohydrate / Microcrystalline Cellulose / Croscarmellose Sodium / Magnesium Stearate / Colloidal Silicon Dioxide | Diluent / Binder / Superdisintegrant / Lubricant / Glidant (Engineered utilizing Extreme Multi-Stage Geometric Dilution to ensure the steroidal payload is flawlessly uniform, manufactured under strict OEB 4 containment protocols to prevent cross-contamination and protect facility operators) |
*Pack Sizes: 10×10 Blisters (Optimized specifically for strict titration, tapering, and chronic immunological dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Rheumatology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.32.00 (Medicaments containing corticosteroid hormones) |
| CAS Number | 14484-47-0 (Deflazacort) |
| Dosage Form | Uncoated or Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | High-Density Alu-PVC or Alu-Alu Blisters. Protects the steroidal formulation from environmental humidity across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect heavily from Moisture and Direct Light. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- OEB 4 Steroidal Containment & Prodrug Dissolution (CRITICAL COMPLIANCE): Deflazacort is a potent synthetic hormone. Airborne steroidal dust on a generic factory floor can cause severe adrenal suppression and immunosuppression in workers. Our production takes place in dedicated, negative-pressure High-Containment Suites (OEB 4) utilizing terminal HEPA filtration. Furthermore, because it is a prodrug, the tablet must dissolve perfectly for the liver to activate it. We utilize rigorous in-vitro dissolution profiling to guarantee absolute pharmacokinetic bioequivalence to the originator brand.
Therapeutic Indications (Human Use)
Indicated for the targeted management of severe inflammatory and autoimmune disorders:
- Duchenne Muscular Dystrophy (DMD): The global standard for preserving muscle strength and prolonging ambulation in pediatric patients with DMD.
- Rheumatology & Autoimmune: Rheumatoid arthritis, systemic lupus erythematosus (SLE), and severe polymyalgia rheumatica.
- Severe Allergies & Asthma: Acute exacerbations of bronchial asthma, severe atopic dermatitis, and intractable allergic rhinitis.
- Immunosuppression: Used in organ transplantation and certain oncological protocols (e.g., leukemias) to aggressively suppress the immune system.
Dosage & Administration
Recommended Dosage (Strictly as per Physician Guidelines):
- Standard Adult Dosing: Highly variable depending on the severity of the disease, ranging from 6 mg up to 90 mg per day.
- The Tapering Mandate (ABSOLUTE CRITICAL): Prolonged use of steroids shuts down the body’s natural adrenal glands. Patients MUST NEVER stop this medication abruptly. The dose must be tapered down slowly over weeks or months to allow the adrenal glands to “wake up” and resume natural cortisol production. Abrupt withdrawal can cause a fatal Adrenal Crisis.
- Administration: Best taken in the morning after breakfast to mimic the body’s natural circadian rhythm of cortisol release and minimize gastric irritation.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Fatal Immunosuppression: Glucocorticoids heavily suppress the immune system. Patients are at a drastically increased risk of severe, fatal fungal, bacterial, and viral infections. Patients should avoid exposure to chickenpox or measles, which can be fatal in steroid-suppressed individuals.
- Adrenal Suppression (HPA Axis): Long-term use causes secondary hypothalamic-pituitary-adrenal (HPA) axis suppression. Patients may require supplemental steroids during times of severe physical stress (trauma, surgery, severe infection).
- Ocular Toxicity: Prolonged use can cause elevated intraocular pressure (glaucoma) and posterior subcapsular cataracts. Routine eye exams are mandatory for chronic users.
- Psychiatric Disturbances: High doses can trigger severe mood swings, steroid-induced psychosis, insomnia, and profound depression.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Rheumatology/Pediatric Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Corticosteroids, Autoimmune Therapeutics, and OEB 4 High-Containment Formulations. Whether you are looking for a reliable Government Tender Supplier for pediatric hospitals in the CIS or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.










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