Povidone Iodine + Ornidazole Ointment

This advanced wound-care formulation belongs to the Ointments category within the Anti-Infectives, Dermatology, and Skin Care therapeutic segments. The combination is critically important in modern surgical and wound management protocols, specifically for complicated or chronic wounds.

Povidone Iodine (5% w/w) acts as a broad-spectrum microbicide, delivering free iodine to eradicate gram-positive/gram-negative bacteria, fungi, and viruses. Ornidazole (1% w/w) is a 5-nitroimidazole derivative that provides deep tissue penetration to selectively target and destroy stubborn anaerobic pathogens commonly responsible for tissue necrosis and foul odor in chronic ulcers.

Saar Biotech manufactures this DCGI-formulated ointment from our manufacturing facility in Baddi, providing third-party and contract manufacturing partners with high-quality, stable, and commercially ready packaging formats.

At Saar Biotech, we manufacture this highly reactive combination ointment using a precision-controlled blending and hydration process that prevents API degradation and maintains uniform consistency.

• Available Iodine Stability: The clinical efficacy of Povidone Iodine relies entirely on the stability of “available iodine” (0.5% w/w). Our R&D team uses validated, temperature-regulated compounding to prevent iodine sublimation and maintain exact therapeutic concentrations across the 24-month shelf life.
• Water-Soluble Ointment Base: Unlike greasy petrolatum bases that can trap exudate and complicate dressing changes, our formulation utilizes a sophisticated water-soluble base. This allows the ointment to be easily washed out of the wound bed with saline, minimizing tissue trauma during redressing.
• Uniform Ornidazole Dispersion: Ornidazole is systematically micronized and incorporated via high-shear homogenization, ensuring smooth, non-gritty application and consistent dosing per gram of ointment.
• Premium Tube Execution: Our semi-solid lines support laminated and aluminum tube filling with precise crimping and sealing, protecting the formulation from environmental oxidation.

Povidone Iodine + Ornidazole Ointment is manufactured by Saar Biotech for the following clinically recognised indications:

• Diabetic Foot Ulcers: Eradication of mixed aerobic/anaerobic biofilms to promote granulation and prevent amputation.
• Chronic Pressure Sores (Bedsores): Managing deep-tissue anaerobic infections common in bed-bound patients.
• Surgical Site Infections: Post-operative wound care and infection prophylaxis.
• Infected Burn Wounds: Broad-spectrum protection against opportunistic pathogens in compromised dermal barriers.
• Traumatic Lacerations & Abrasions: Initial antimicrobial management of dirty or contaminated wounds.

Schedule H — Requires a valid medical prescription. Prolonged use on large wound areas must be physician-supervised to monitor for systemic iodine absorption.

Clinical Mechanism of Action

Povidone Iodine is a water-soluble complex of iodine and the polymer polyvinylpyrrolidone (povidone). Upon contact with wound exudate, it slowly releases free, active iodine. This iodine rapidly penetrates microbial cell membranes and oxidizes amino acids, nucleotides, and fatty acids, resulting in irreversible disruption of cellular structures and rapid pathogen death without inducing bacterial resistance.

Ornidazole is an antiprotozoal and antibacterial agent. Once absorbed by anaerobic bacteria in the wound bed, its nitro group is enzymatically reduced by the pathogen’s ferredoxin system. This reduction generates highly reactive intermediates that bind to microbial DNA, causing strand breakage, inhibiting nucleic acid synthesis, and leading to selective anaerobic cell death.

Manufacturing Integrity

• Assay Verification: Every batch undergoes strict titrimetric analysis to confirm exact Available Iodine levels, alongside HPLC analysis for Ornidazole content, ensuring 100% compliance with IP reference standards.
• Microbial Limit Testing: The finished ointment is subjected to rigorous MLT to guarantee the absence of external pathogens, ensuring absolute safety when applied to open wounds.

Saar Biotech provides comprehensive Contract Manufacturing and Third-Party Manufacturing for Povidone Iodine + Ornidazole 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 and 20gm formats in laminated or aluminum tubes; customized mono-cartons, flap cartons, and bulk shipper configurations.
• MOQ: 5,000 to 10,000 tubes per SKU, accommodating both 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 Povidone Iodine + Ornidazole Ointment is quarantined and subjected to the following analytical release protocol:

• Available Iodine Titration: Confirms exactly 0.5% w/w available iodine to ensure potent microbicidal activity.
• HPLC Assay (Ornidazole): Verification of Ornidazole content against IP standards.
• pH & Viscosity Testing: Ensures the water-soluble base remains stable, spreadable, and non-irritating to open tissues.
• 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 Povidone Iodine + Ornidazole Ointment, please use the enquiry form below.