Beclomethasone Dipropionate + Clotrimazole Cream

Beclomethasone + Clotrimazole Cream belongs to the Creams and External Preparations category within the Anti-Fungal and Dermatology therapeutic segments. This formulation addresses a common clinical challenge in dermatology practice — fungal skin infections complicated by significant inflammatory symptoms — where monotherapy with either an antifungal or a steroid alone is suboptimal.

Clotrimazole 1% w/w is an imidazole antifungal with broad-spectrum activity against dermatophytes (Trichophyton, Microsporum, Epidermophyton), yeasts (Candida species), and Malassezia — the principal organisms responsible for tinea infections. Beclomethasone Dipropionate 0.025% w/w is a fluorinated topical glucocorticoid that provides rapid anti-inflammatory, antipruritic, and vasoconstrictive action to relieve the erythema, oedema, and intense itch that often accompany fungal infections at presentation.

Saar Biotech manufactures this DCGI-formulated cream from our manufacturing facility in Baddi, available for third-party and contract manufacturing partners in 10gm, 15gm, 20gm, and 30gm tube formats with full artwork customization.

At Saar Biotech, we manufacture Beclomethasone + Clotrimazole Cream using a precision-controlled semi-solid homogenization process that ensures both active ingredients remain evenly dispersed and potency-stable throughout the cream base.

• Two-API Uniform Dispersion: Beclomethasone Dipropionate and Clotrimazole have different physicochemical properties. Our validated blending sequence and in-process viscosity monitoring ensure neither API settles or concentrates unevenly — delivering consistent dose application from every squeeze of the tube.
• Stable pH-Optimized Base: The cream base is formulated within a pH range that maintains the chemical stability of both the corticosteroid ester and the azole antifungal, preventing hydrolytic degradation during the 24-month shelf life under tropical storage conditions.
• Premium Tube Finish Execution: Our semi-solid manufacturing lines support both standard sticker-labelled laminated tubes and metallic embossed premium tubes — giving dermatology brands a visually differentiated pharmacy shelf presence.
• Regulatory-Ready Artwork: Saar Biotech’s coordination team ensures all carton artwork includes correct drug concentration disclosure, external-use statements, and Schedule M-compliant prescription warnings before production begins.

Beclomethasone + Clotrimazole Cream is manufactured by Saar Biotech for the following clinically recognised indications:

• Tinea Infections with Inflammation: Tinea corporis (ringworm), tinea cruris (jock itch), tinea pedis (athlete’s foot) — where significant erythema, oedema, or pruritus accompanies the fungal infection
• Cutaneous Candidiasis: Superficial Candida infections of the skin folds with associated inflammatory signs
• Seborrhoeic Dermatitis (Fungal Component): Where Malassezia contributes to scalp or facial seborrhoeic conditions requiring both antifungal and anti-inflammatory management
• Mixed Dermatophytosis: Cases where dermatophyte infection is confirmed but inflammatory response is disproportionate and requires dual management

Schedule H — Requires a valid medical prescription. Steroidal component means duration of use must be physician-supervised.

Clinical Mechanism of Action

Clotrimazole acts by inhibiting the fungal cytochrome P450-dependent enzyme 14-alpha-sterol demethylase, which is responsible for converting lanosterol to ergosterol. Ergosterol is the principal structural sterol of fungal cell membranes. Its depletion disrupts membrane fluidity, permeability, and integrity — ultimately causing fungal cell death. Clotrimazole demonstrates fungicidal activity against Candida species and fungistatic activity against most dermatophytes at the 1% concentration.

Beclomethasone Dipropionate is a prodrug that is metabolised on the skin to the active beclomethasone 17-monopropionate, which binds glucocorticoid receptors in dermal cells, inhibiting phospholipase A2 (via lipocortin synthesis) and suppressing the arachidonic acid cascade. This reduces the synthesis of prostaglandins, leukotrienes, and cytokines responsible for vasodilatation, oedema, erythema, and pruritus.

Manufacturing Integrity

• API Compatibility Assurance: Both actives are validated for chemical compatibility in the cream base. The formulation avoids degradation pathways that could arise from unfavourable pH, oxidative conditions, or incompatible excipients.
• Homogeneity Protocol: In-process checks at defined blending intervals confirm uniform API distribution before tube filling. Final batch HPLC assay independently confirms both Clotrimazole and Beclomethasone Dipropionate content against IP specification limits.

Saar Biotech provides Contract Manufacturing and Third-Party Manufacturing for Beclomethasone + Clotrimazole Cream from our dedicated semi-solid manufacturing facility in Baddi, Himachal Pradesh.

• Facility: Semi-solid manufacturing block with planetary mixer homogenizers, temperature-controlled blending vessels, and automated laminated tube filling and crimping lines.
• Capacity: From 5,000-unit brand-entry batches to 2,00,000+ unit commercial runs.
• Quality Lab: In-house GLP-certified laboratory with HPLC assay for both APIs, pH, viscosity, and MLT.
• Turnaround: New orders — 30 to 45 working days. Repeat orders — 20 to 25 working days.
• Packaging: 10gm, 15gm, 20gm, and 30gm laminated tubes; sticker label, metallic tube, mono-carton, drip-off embossed carton, flap carton.
• MOQ: 5,000–10,000 tubes per SKU.

1. Temperature Control: Store below 30°C in a cool, dry place. Avoid storage in bathrooms or near heat sources.
2. Light Protection: Keep the tube in its carton until use to protect the corticosteroid component from photodegradation.
3. Cap Discipline: Replace the cap firmly after each application to prevent air exposure and microbial contamination.
4. Application Hygiene: Apply with clean hands or a spatula. Do not allow the tube nozzle to contact the skin directly.

Every commercial batch of Beclomethasone + Clotrimazole Cream is quarantined until it passes the following analytical release protocol:

• HPLC Assay (Dual API): Individual quantification of Beclomethasone Dipropionate and Clotrimazole against IP reference standards.
• pH Testing: Verification of the finished cream pH within the specified stability range.
• Viscosity Testing: Batch-to-batch consistency confirmed.
• Microbial Limit Testing (MLT): Absence of specified pathogens; total aerobic count within IP limits for topical preparations.
• Net Content Verification: Tube fill weight checked against declared net content.
• Certificate of Analysis (COA): Issued with every B2B batch for partner records.

Common Side Effects: Mild local burning, stinging, or erythema at application site during initial use — typically self-resolving.

With Prolonged Misuse: Skin atrophy, striae, telangiectasia, perioral dermatitis, acneiform eruptions, or secondary infection due to corticosteroid-induced immune suppression at the application site.

Contraindications: Known hypersensitivity to beclomethasone, clotrimazole, or any cream excipient. Not for use on viral infections, acne, rosacea, or perioral dermatitis.

Precautions: Avoid occlusive dressings. Use with caution in children, on facial skin, and during pregnancy. Consult physician if no improvement within 2 weeks of use.

For B2B manufacturing enquiries, third-party contracts, or to request complete product dossier and pricing for Beclomethasone Dipropionate + Clotrimazole Cream, please use the enquiry form below.