Terbinafine HCl + Mometasone Furoate Cream

Terbinafine + Mometasone Cream belongs to the Creams and External Preparations category within the Anti-Fungal and Dermatology therapeutic segments. The rationale for this combination lies in the clinical reality of tinea presentations: fungal infections commonly trigger an intense host inflammatory response that causes distressing pruritus and erythema disproportionate to the infection severity.

Terbinafine Hydrochloride 1% w/w — an allylamine antifungal — delivers fungicidal action against Trichophyton, Microsporum, and Epidermophyton dermatophytes through squalene epoxidase inhibition. This makes terbinafine one of the most effective topical antifungals for tinea treatment, achieving high keratin-binding concentrations that persist in the stratum corneum long after application. Mometasone Furoate 0.1% w/w — a medium-to-high potency fluorinated corticosteroid — provides rapid anti-inflammatory, antipruritic, and vasoconstrictive action to address the inflammatory component simultaneously.

Saar Biotech manufactures this combination at our manufacturing facility in Baddi, Himachal Pradesh, for B2B third-party and contract manufacturing partners in 10gm and 20gm tube formats.

At Saar Biotech, we manufacture Terbinafine + Mometasone Cream using a precision-controlled semi-solid blending process designed to ensure two-API uniform dispersion and long-term formulation stability.

• Allylamine API Stability: Terbinafine Hydrochloride requires a specific base pH range to maintain physicochemical stability. Saar Biotech formulates the cream base with a pH-optimized excipient system validated against accelerated and real-time stability data.
• Mometasone Ester Integrity: Mometasone Furoate as a corticosteroid ester is susceptible to hydrolytic degradation in an inappropriate base. Our formulation chemistry and controlled humidity manufacturing environment prevent premature ester hydrolysis, maintaining potency through the 24-month shelf life.
• Two-Active Uniform Dispersion: In-process viscosity monitoring and sampling at defined blending intervals confirm that neither API concentrates disproportionately in any zone of the batch, ensuring dose accuracy from the first tube to the last.
• Prescription-Quality Tube Finish: 10gm starter packs for prescription samples and 20gm retail tubes are both produced with premium laminated tube finish — sticker label, metallic tube, or embossed carton — giving your brand a professional pharmacy shelf presence.

Terbinafine + Mometasone Cream is manufactured and supplied by Saar Biotech for the following DCGI-recognized clinical applications:

• Tinea Corporis (Ringworm): Circular, scaling, inflammatory dermatophytic lesions on the trunk, arms, or legs — where both antifungal treatment and anti-inflammatory symptom control are required
• Tinea Cruris (Jock Itch): Dermatophytic infection of the groin and inner thighs with associated erythema, pruritus, and scaling
• Tinea Pedis (Athlete’s Foot): Interdigital or plantar dermatophytic infection with inflammatory signs, maceration, or pruritic plaques
• Mixed Presentations: Cases where dermatophyte culture or KOH microscopy confirms fungal aetiology but inflammatory response warrants concurrent corticosteroid management

Schedule H — Requires a valid medical prescription. Corticosteroid-containing topical preparations must be used for the shortest effective duration under physician supervision.

Clinical Mechanism of Action

Terbinafine (1%) acts at the cell membrane biosynthesis level: it inhibits squalene epoxidase (an enzyme in the fungal sterol synthesis pathway) with high selectivity for the fungal enzyme over mammalian equivalents. This selective inhibition causes toxic squalene accumulation within the fungal cell while simultaneously depleting ergosterol — the structural sterol required for membrane integrity. The result is fungicidal activity against most dermatophytes at clinically achievable concentrations.

Mometasone Furoate (0.1%) is a prodrug that undergoes cutaneous esterase metabolism to the active ester form, which then binds glucocorticoid receptors in the dermis with high affinity. Via increased lipocortin synthesis, it inhibits phospholipase A2, blocking the production of arachidonic acid metabolites — prostaglandins, thromboxanes, and leukotrienes — that mediate vasodilation, oedema, erythema, and pruritus.

Manufacturing Integrity

• API Compatibility Protocol: Pre-blending compatibility studies confirm that terbinafine HCl and mometasone furoate remain chemically stable in the selected cream base under the processing conditions used at Saar Biotech’s Baddi facility.
• Dual HPLC Validation: Final batch release is not issued without individual HPLC assay confirmation for both terbinafine hydrochloride and mometasone furoate against IP reference standards.

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

• Facility: Semi-solid cream manufacturing block with homogenizer mixing vessels, temperature-controlled blending, and automated laminated tube filling, crimping, and carton packing lines.
• Packaging: 10gm and 20gm laminated tubes with sticker label, printed tube, mono-carton, or drip-off embossed carton.
• MOQ: 5,000 to 2,00,000+ tubes per batch.
• Turnaround: New orders — 30–45 working days from artwork sign-off; Repeat orders — 20–25 working days.
• Documentation: Full COA, batch manufacturing record, and stability data on request.

Every commercial batch undergoes the following release protocol before dispatch:

For B2B manufacturing enquiries, contract pricing, or complete product dossier for Terbinafine HCl + Mometasone Furoate Cream, please use the enquiry form below.