Mupirocin 2% Ointment

Mupirocin 2% Ointment belongs to the Ointments category and is classified as a topical antibacterial agent. It is a Schedule H product requiring a valid medical prescription for dispensing in India.

Key clinical characteristics:

• Indication: Topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes
• Mechanism: RNA synthetase inhibitor that reversibly binds to bacterial isoleucyl transfer-RNA synthetase
• Spectrum: Active against MRSA and other gram-positive bacteria
• Application: 3 times daily for up to 10 days

Saar Biotech manufactures DCGI-approved formulations of Mupirocin 2% Ointment from our manufacturing facility in Baddi, available in 5gm, 10gm, and 15gm laminated tube formats.

At Saar Biotech, we manufacture Mupirocin 2% Ointment using precision-controlled manufacturing processes to ensure consistent potency, purity, and stability.

• API Uniformity: Homogeneous dispersion of Mupirocin is achieved through a validated mixing sequence and controlled temperature homogenization.

• Viscosity Consistency: Every batch is tested for viscosity within a defined specification range to ensure the ointment spreads easily on application.

• pH-Optimised Base: The ointment base is formulated and verified within a skin-compatible pH range.

• Tube Filling Precision: Automated laminated tube filling lines ensure accurate fill weight per tube.

Mupirocin 2% Ointment is manufactured by Saar Biotech for the following clinically recognised indications:

• Impetigo: Primary indication — topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes

• Secondary Skin Infections: Treatment of secondarily infected skin conditions

• MRSA Infections: Effective against methicillin-resistant Staphylococcus aureus

How Mupirocin Works

Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase. This unique mechanism of action makes it effective against bacteria that have developed resistance to other antibiotics, including MRSA.

Manufacturing Integrity

• Chemical Stability: Mupirocin is stable in the ointment base when formulated correctly.
• Preservation System: The ointment base includes appropriate preservatives to maintain product integrity.

Saar Biotech offers specialised Contract Manufacturing (CMO) and Third-Party Manufacturing services for Mupirocin 2% Ointment 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.
• Quality Lab: GLP-certified in-house QC with HPLC, pH metres, viscometers, and stability chambers.
• Turnaround: 30–45 working days for new orders; 20–25 working days for established repeat partners.
• Packaging: 5gm, 10gm, and 15gm laminated aluminium tubes with custom mono-carton and label design.
• Regulatory: DCGI-compliant; full COA, batch records, and stability data provided.
• MOQ: 5,000–10,000 tubes per SKU.

1. Sealed Tube Storage: Store below 30°C in a cool, dry location away from direct sunlight and heat sources. Do not freeze.
2. In-Use Handling: Replace the cap firmly after each use.
3. Application Precautions: Apply exclusively to intact skin. Keep away from eyes, mucous membranes, and broken skin.

Every batch is released only after completing the following analytical protocol:

• HPLC Assay: Confirmation of Mupirocin 2% label claim accuracy.
• pH Testing: Verification that the ointment’s pH is within the skin-compatible specification range.
• Viscosity Testing: Measurement of ointment viscosity confirming batch-to-batch consistency.
• Microbial Limit Test (MLT): Confirms total aerobic count and absence of specified pathogens.
• Certificate of Analysis (COA): Issued with every B2B consignment.

Common Side Effects: Burning, stinging, or itching at the application site.

Contraindications: History of sensitivity reactions to any of the components.

Precautions: For topical use only. Not for use in the eyes, nose, mouth, or on large areas of broken skin. Discontinue use if severe irritation or allergic reaction occurs.

For B2B manufacturing enquiries, third-party contracts, or to request complete product details for Mupirocin 2% Ointment, please use the enquiry form below.