Luliconazole Cream

Luliconazole 1% Cream belongs to the Creams category and is classified as a topical antifungal preparation. It is a Schedule H product requiring a valid medical prescription for dispensing in India.

Luliconazole is an azole antifungal that works by preventing the growth of the fungus. It is effective against dermatophytes including Trichophyton rubrum and Epidermophyton floccosum.

Key clinical characteristics:

• Indications: Tinea pedis (athlete’s foot), Tinea cruris (jock itch), Tinea corporis (ringworm)
• Application: Once daily for 2–4 weeks
• Route: Topical use only — not for oral or ophthalmic use

Saar Biotech manufactures DCGI-approved formulations of Luliconazole 1% Cream from our manufacturing facility in Baddi, available in 15gm, 30gm, and 50gm laminated tube formats.

At Saar Biotech, we manufacture Luliconazole 1% Cream using a precision-controlled homogenization process that ensures every tube delivers uniform API distribution, consistent sensory performance, and stable shelf-life potency.

• API Uniformity: Homogeneous dispersion of Luliconazole is achieved through a validated mixing sequence and controlled temperature homogenization. Segregation of the active within the cream matrix is the most common quality failure in topical products; our process eliminates this variability batch-to-batch.

• Viscosity Consistency: Every batch is tested for viscosity within a defined specification range to ensure the cream spreads easily on application, absorbs without residue, and maintains the correct texture through its 24-month shelf life.

• pH-Optimised Base: The cream base is formulated and verified within a skin-compatible pH range to prevent cutaneous irritation and maintain the chemical stability of Luliconazole.

• Tube Filling Precision: Automated laminated tube filling lines in Baddi ensure accurate fill weight per tube with minimal variation, maintaining label claim integrity and reducing material wastage across large commercial runs.

This manufacturing discipline ensures that your brand delivers a consistent therapeutic experience — the sensory signature (texture, absorption, non-greasy feel) and the clinical outcome must be identical from the first tube to the last in every batch.

Luliconazole 1% Cream is manufactured by Saar Biotech for the following clinically recognised indications:

• Tinea Pedis (Athlete’s Foot): Fungal infection of the skin on the feet and between the toes
• Tinea Cruris (Jock Itch): Fungal infection of the skin in the groin or buttocks
• Tinea Corporis (Ringworm): Fungal infection that causes a red scaly rash on different parts of the body

How Luliconazole Works

Luliconazole is an azole antifungal that inhibits the enzyme lanosterol demethylase, which is needed for the synthesis of ergosterol — a major component of fungal cell membranes. By blocking ergosterol production, luliconazole weakens the fungal cell membrane, causing the fungus to die. It kills the organisms Trichophyton rubrum and Epidermophyton floccosum by altering their fungal cell membranes.

Manufacturing Integrity

• Chemical Stability: Luliconazole is sensitive to pH and temperature changes during manufacturing. Our cream base is prepared at controlled temperature with validated pH adjustment before API incorporation, preventing degradation of the active.

• Preservation System: The cream base includes a validated preservative system that maintains microbiological integrity throughout the product’s shelf life and during repeated use.

Luliconazole 1% Cream has well-characterised topical pharmacokinetics that make it both clinically effective and commercially attractive for branded pharma partners.

• Rapid Absorption: After administration, absorption is rapid and complete.
• Distribution: Well distributed to various sites, including normal skin, nails, and blister skin.
• Metabolism: Primarily metabolised hepatically.
• Excretion: Primarily excreted via the kidneys; more than 80% of an administered dose is excreted unchanged in the urine.

Saar Biotech offers specialised Contract Manufacturing (CMO) and Third-Party Manufacturing services for Luliconazole 1% Cream from our semi-solid manufacturing facility in Baddi, Himachal Pradesh.

• Facility: Dedicated semi-solid manufacturing lines with planetary mixer homogenizers and automated laminated tube filling and sealing equipment.
• Capacity: Pilot batches from 5,000 tubes to commercial runs of 1,00,000+ tubes per production cycle.
• Quality Lab: GLP-certified in-house QC with HPLC, pH metres, viscometers, and stability chambers for complete batch release testing.
• Turnaround: 30–45 working days for new orders; 20–25 working days for established repeat partners.
• Packaging: 15gm, 30gm, and 50gm laminated aluminium tubes with custom mono-carton, flap carton, and label design; custom sizes available on request.
• Regulatory: DCGI-compliant; full COA, batch records, and stability data provided. Brand name search and approval support available. Schedule M labelling compliance verified on all artwork.
• MOQ: 5,000–10,000 tubes per SKU per strength variant, with flexibility for new entrants.

1. Sealed Tube Storage: Store below 30°C in a cool, dry location away from direct sunlight and heat sources. Do not freeze — freezing disrupts the cream matrix homogeneity and can cause phase separation. Store tubes with caps tightly closed.

2. In-Use Handling: After opening, tubes should be used within the expiry period. Replace the cap firmly after each use to minimise exposure of the product to air and light.

3. Application Precautions: Apply exclusively to intact skin. Keep away from eyes, mucous membranes, and any broken or infected skin area. Wash hands immediately after each application unless hands are the area being treated.

Every batch of Luliconazole 1% Cream at Saar Biotech is released from our GLP-certified quality control laboratories in Baddi only after completing the following analytical protocol:

• HPLC Assay (Label Claim): Individual assay of Luliconazole by validated HPLC methods confirming the active meets 98–102% of the stated label claim per IP specifications.

• pH Testing: Verification that the cream’s pH is within the skin-compatible, stability-appropriate specification range.

• Viscosity Testing: Measurement of cream viscosity using a calibrated viscometer at standard temperature conditions, confirming batch-to-batch consistency in texture, spreadability, and dispensing behaviour from the tube.

• Microbial Limit Test (MLT): Confirms total aerobic count and absence of specified pathogens per IP limits — essential for a topical product applied repeatedly to skin.

Luliconazole 1% Cream is generally well-tolerated when applied as directed to intact skin.

Common side effects may include:

• Increased inflammation
• Redness
• Pain at the application site

Contraindications: Known hypersensitivity to luliconazole or any component of the cream. An allergic reaction could manifest as rash, itching, swelling, dizziness, or difficulty breathing.

Pregnancy & Breastfeeding: There is limited data on the safety of luliconazole in pregnant or breastfeeding women. It should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Caution is also advised when using it during breastfeeding.

Healthcare professionals should refer to the complete prescribing information for full safety and interaction data.

For B2B manufacturing enquiries, third-party contracts, or to request complete product details for Luliconazole 1% Cream, please use the enquiry form below.