Ofloxacin + Metronidazole + Simethicone Suspension

Ofloxacin + Metronidazole + Simethicone Suspension belongs to the Suspensions category within the Antibiotics, Gastroenterology, and Anti-Infectives therapeutic segments — addressing both the infective cause and symptomatic manifestations of gastrointestinal infections.

The clinical logic of this three-molecule combination is comprehensive:

• Ofloxacin 50 mg — a fluoroquinolone antibiotic effective against a wide range of Gram-negative and Gram-positive bacteria, including those commonly implicated in gastrointestinal infections.
• Metronidazole 120 mg — an antimicrobial agent effective against anaerobic bacteria and protozoa, including Giardia lamblia, Entamoeba histolytica, and Clostridium difficile.
• Simethicone 10 mg — an anti-flatulent that reduces gas bubbles in the gastrointestinal tract, providing relief from bloating and abdominal discomfort.

For pharmaceutical marketing companies, this product is a seasonally robust SKU with repeat prescription cycles driven by gastrointestinal infections during monsoon and throughout the year. Saar Biotech manufactures it from our manufacturing facility in Baddi with validated three-API suspension quality control and complete 30ml and 60ml packaging options.

At Saar Biotech, we manufacture Ofloxacin + Metronidazole + Simethicone Suspension using a controlled oral suspension manufacturing process that ensures dose uniformity, taste masking, and packaging reliability for the highly competitive anti-diarrhoeal segment.

• Three-API Suspension Uniformity: Each of the three active ingredients must be uniformly distributed in the suspension vehicle. Saar Biotech’s high-shear mixing and validated fill procedures ensure this dose-to-dose consistency — which is pharmacologically critical for both Ofloxacin and Metronidazole, where under-dosing can lead to treatment failure.

• Taste Masking: Gastrointestinal suspensions must taste acceptable to patients who already feel unwell. We develop mango and mixed fruit-flavoured suspension bases that mask the residual bitterness of Ofloxacin and Metronidazole — ensuring patients accept each dose without resistance.

• pH and Stability Management: All three actives must remain chemically stable for 24 months under tropical storage conditions. Our formulation team selects preservatives, pH buffers, and suspending agents that protect all actives from chemical degradation.

• 30ml and 60ml Pack Coverage: From dark amber bottles to drip-off embossed cartons, metallic labels, and company-logo printed caps — Saar Biotech’s packaging options help anti-diarrhoeal brands stand out at pharmacy level.

Ofloxacin + Metronidazole + Simethicone Suspension is manufactured and supplied by Saar Biotech for the following established clinical indications:

• Acute Diarrhoea: The primary indication. Ofloxacin and Metronidazole provide broad-spectrum antibacterial and antiprotozoal coverage for infectious diarrhoea, while Simethicone relieves associated bloating and gas.

• Gastrointestinal Infections: Effective against bacterial and protozoal infections of the gastrointestinal tract, including amoebiasis, giardiasis, and bacterial enteritis.

• Abdominal Discomfort & Bloating: Simethicone provides symptomatic relief from gas-related abdominal discomfort that often accompanies gastrointestinal infections.

• Infectious Gastroenteritis: The combination addresses both the infective cause and the symptomatic manifestations of gastroenteritis.

Three-Component Clinical Mechanism

Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, preventing bacterial DNA replication and transcription — leading to bacterial cell death. It is effective against a wide range of Gram-negative and Gram-positive bacteria.

Metronidazole enters microbial cells and is reduced to toxic free radicals that damage microbial DNA, causing cell death. It is effective against anaerobic bacteria and protozoa.

Simethicone acts as a surfactant, reducing the surface tension of gas bubbles in the gastrointestinal tract, facilitating their expulsion and providing relief from bloating and discomfort.

Manufacturing Integrity

• Three-API Suspension Uniformity: Each of the three active ingredients must be uniformly distributed in the suspension vehicle. Our formulation team selects suspending agents that maintain uniform dispersion of all three actives.

• pH and Stability Management: The suspension vehicle must remain chemically stable for 24 months under tropical storage conditions. Our formulation team selects preservatives, pH buffers, and suspending agents that protect all three actives from chemical degradation.

• Rapid Onset of Action: Ofloxacin and Metronidazole are well absorbed from the gastrointestinal tract, with Tmax typically achieved within 1–2 hours. This fast onset creates a clear clinical outcome that both patients and prescribers notice quickly.

• Seasonal Repeat Demand: Anti-diarrhoeal suspensions are among the highest-frequency repurchase pharmaceutical products in the Indian market, particularly during monsoon and gastrointestinal illness seasons.

• 30ml and 60ml Pack Logic: The 30ml format is ideal for pediatric use and short treatment courses, while the 60ml format covers standard adult treatment courses.

Saar Biotech provides Third-Party Manufacturing and Contract Manufacturing for Ofloxacin + Metronidazole + Simethicone Suspension from our dedicated oral suspension manufacturing facility in Baddi, Himachal Pradesh.

• Facility: Oral liquid and suspension manufacturing area with controlled processing, automated bottle filling, capping, labelling, and carton packing lines suited for 30ml and 60ml presentations.
• Capacity: Scalable from brand-entry launches to large seasonal batches; 200×30ml, 160×60ml distributor dispatch configurations available.
• Quality Lab: In-house GLP-certified lab with validated HPLC assay for all three actives, plus pH, viscosity, suspension uniformity, MLT, and fill volume checks.
• Turnaround: New orders — 30 to 45 working days. Repeat orders — 20 to 25 working days.
• Packaging: 30ml and 60ml PET or dark amber bottles; sticker label, metallic label, silver leafing, drip-off carton, brand embossed carton, measuring cup, printed cap, with-carton or without-carton supply.
• MOQ: Starting at 5,000–10,000 units per SKU.

1. Warehouse Conditions: Store below 30°C in a cool, dry environment. Do not freeze — sub-zero temperatures will disrupt the suspension matrix.
2. Shake Well Before Every Dose: This is the single most important user instruction for a suspension product. Proper shaking ensures all three actives are uniformly redispersed.
3. Measuring Cup Use: A calibrated measuring cup must accompany the bottle. Household spoons are unreliable for accurate dosing.
4. Light Protection: Dark amber bottles and outer cartons protect the suspension from light-induced degradation.

Every commercial batch of Ofloxacin + Metronidazole + Simethicone Suspension is quarantined until it passes a comprehensive analytical release protocol:

• Three-API HPLC Assay: Simultaneous quantification of Ofloxacin 50mg, Metronidazole 120mg, and Simethicone 10mg per 5ml against IP specifications.
• Suspension Uniformity & Re-Dispersibility: Sediment behaviour and post-shaking uniformity are evaluated to ensure dose-to-dose consistency.
• pH & Viscosity Testing: The suspension vehicle’s pH and flow characteristics are monitored to maintain stability.
• Microbial Limit Testing (MLT): IP-compliant microbiological testing confirming absence of specified pathogens.
• Fill Volume & Pack Inspection: Automated fill-volume checks, cap torque, measuring-cup inclusion, label placement, and carton accuracy are verified before dispatch.
• Certificate of Analysis (COA): Issued with every B2B batch.

• Arthropathy Risk (Ofloxacin): Ofloxacin is generally not recommended for children under 18 years of age due to the risk of cartilage damage. Use in pediatric patients should be restricted to specific indications where benefits outweigh risks.

• Peripheral Neuropathy (Metronidazole): Metronidazole can cause peripheral neuropathy with prolonged use. Patients should be monitored for neurological symptoms.

• Hepatic Precautions: Metronidazole is metabolised in the liver; use with caution in patients with hepatic impairment.

• Renal Precautions: Ofloxacin is excreted renally; dose adjustment may be required in patients with renal impairment.

• Contraindications: Hypersensitivity to fluoroquinolones or nitroimidazoles, blood dyscrasias, and first trimester of pregnancy.

For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Ofloxacin + Metronidazole + Simethicone Suspension, please use the B2B enquiry form below.