Halobetasol Propionate + Salicylic Acid Ointment

This advanced topical formulation belongs to the Ointments category within the Dermatology and Skin Care therapeutic segments. It represents a critical intervention in dermatology for conditions where standard corticosteroid monotherapy fails due to thick, impenetrable epidermal plaques.

Halobetasol Propionate (0.05% w/w) is a Class 1 super-potent fluorinated corticosteroid that delivers profound, rapid suppression of epidermal inflammation, cellular proliferation, and severe pruritus. Salicylic Acid (3% w/w) acts as an essential keratolytic synergist; it dissolves the intercellular cement of the thickened stratum corneum, exfoliating dead scaly tissue and dramatically increasing the dermal absorption of the Halobetasol.

Saar Biotech manufactures this highly specialized DCGI-formulated ointment from our manufacturing facility in Baddi, providing third-party and contract manufacturing partners with a visually premium and clinically flawless product.

At Saar Biotech, we manufacture this complex dermatological combination using a precision-controlled homogenization and micronization process that prevents physical separation and ensures a cosmetically elegant patient experience.

• API Micronization & Dispersion: Salicylic Acid can create a gritty, unpleasant texture if improperly incorporated. Our manufacturing process utilizes advanced API micronization and high-shear vacuum blending to ensure uniform, microscopic dispersion of both active ingredients, resulting in a smooth, highly spreadable ointment.
• Base Optimization for Penetration: The vehicle (base) is crucial for super-potent steroids. Our proprietary ointment base is specifically engineered to maximize the thermodynamic activity and epidermal permeation of Halobetasol, while maintaining physical stability in extreme tropical temperatures.
• Premium Tube Execution: Our semi-solid lines support premium laminated tube filling with precise crimping, ensuring the formulation is protected from environmental oxidation and moisture.
• Regulatory-Ready Artwork: Our coordination team ensures all carton artwork includes correct drug concentration disclosures, strict external-use statements, and Schedule M-compliant prescription warnings (including duration-of-use limits) before production begins.

Halobetasol Propionate + Salicylic Acid Ointment is manufactured by Saar Biotech for the following severe clinical indications:

• Plaque Psoriasis: Rapid clearance of thick, scaly, erythematous plaques that are resistant to lower-potency steroids.
• Severe Eczematous Dermatoses: Management of chronic, lichenified eczema where hyperkeratosis blocks drug entry.
• Lichen Planus: Suppression of severe inflammation and intensely pruritic papules.
• Localized Neurodermatitis (Lichen Simplex Chronicus): Breaking the itch-scratch cycle and reducing epidermal thickening.
• Palmoplantar Dermatoses: Managing severe inflammatory conditions on the thick skin of the palms and soles.

Schedule H — Requires a valid medical prescription. Due to ultra-high potency, use is typically restricted to 2 weeks of continuous therapy by dermatologists.

Clinical Mechanism of Action

Salicylic Acid provides the crucial first step in this combination’s efficacy. As a keratolytic and desmolytic agent, it lowers the pH of the stratum corneum, increasing the hydration of keratin and dissolving the desmosomes (cellular glue) holding the squames together. This exfoliates the thick psoriatic scale and physically opens the epidermal barrier.

Halobetasol Propionate then penetrates deeply into the dermis. It binds aggressively to intracellular glucocorticoid receptors, translocates to the nucleus, and induces the synthesis of lipocortins. Lipocortins inhibit phospholipase A2, thereby completely shutting down the arachidonic acid cascade and stopping the production of inflammatory prostaglandins and leukotrienes. This halts vasodilation, edema, and leukocyte migration instantly.

Manufacturing Integrity

• Assay Verification: Every batch undergoes dual HPLC analysis to independently quantify both Halobetasol Propionate and Salicylic Acid, ensuring 100% compliance with USP and IP reference standards respectively.
• Microbial Limit Testing: The finished ointment is subjected to rigorous MLT to guarantee the absolute absence of specified pathogens, ensuring patient safety on compromised skin barriers.

Saar Biotech provides comprehensive Contract Manufacturing and Third-Party Manufacturing for Halobetasol + Salicylic Acid Ointment from our dedicated semi-solid manufacturing facility in Baddi, Himachal Pradesh.

• Facility: Advanced semi-solid block with vacuum planetary mixers, automated tube filling, and high-precision crimping technology.
• Packaging Options: 15gm, 20gm, and 30gm formats in laminated tubes; customized mono-cartons, flap cartons, and bulk shipper configurations.
• MOQ: 5,000 to 10,000 tubes per SKU, accommodating both derma-brand market-entry and high-volume commercial scales.
• Turnaround Time: 30–45 working days for new brand formulations; 20–25 days for repeat orders.
• Quality Documentation: Complete GLP-signed Certificate of Analysis (COA) issued with every batch.

Every commercial batch of Halobetasol + Salicylic Acid Ointment is quarantined and subjected to the following analytical release protocol:

• HPLC Assay (Dual API): Verification of Halobetasol Propionate and Salicylic Acid content against USP/IP standards.
• pH & Viscosity Testing: Ensures the ointment base remains stable, spreadable, and non-irritating over its shelf life.
• Microbial Limit Testing (MLT): Confirms the absence of specified pathogens per IP topical standards.
• Net Content Verification: Weight checks to guarantee accurate fill volume per tube.

For B2B manufacturing enquiries, third-party contracts, or to request a complete product dossier and pricing for Halobetasol Propionate + Salicylic Acid Ointment, please use the enquiry form below.