Ofloxacin + Tinidazole Suspension
Ofloxacin IP 50mg + Tinidazole IP 50mg Oral Suspension · Antibiotics, Gastroenterology, Anti-Infectives
SUSPENSION PRESENTATION (Standard Strength):
SUSPENSION PRESENTATION (Double Strength):
Product Profile
Ofloxacin + Tinidazole Suspension is a clinically established, broad-spectrum anti-diarrhoeal formulation indicated for gastrointestinal infections caused by susceptible bacteria and protozoa. As a premier WHO-GMP certified pharmaceutical manufacturer in Baddi, Saar Biotech manufactures this suspension with validated two-API quality control and precise taste-masking, ensuring reliable therapeutic performance in every 5ml dose.
DCGI Approved
Comprehensive documentation and CDSCO support for rapid market entry in India.
Fast Turnaround
30-45 days lead time for new batches with state-of-the-art logistics.
Pan-India Supply & Contract Manufacturing
Description & Therapeutic Class
Ofloxacin + Tinidazole Suspension belongs to the Suspensions category within the Antibiotics, Gastroenterology, and Anti-Infectives therapeutic segments. This combination addresses both bacterial and protozoal causes of gastrointestinal infections.
- Ofloxacin 50mg/100mg — fluoroquinolone antibiotic effective against Gram-negative and Gram-positive bacteria
- Tinidazole 50mg/100mg — nitroimidazole effective against anaerobic bacteria and protozoa
For pharmaceutical marketing companies, this is a high-prescription anti-diarrhoeal product with consistent demand, particularly during monsoon and gastrointestinal illness seasons. Saar Biotech manufactures it from our manufacturing facility in Baddi with validated two-API suspension quality control.
Pan-India Supply & Contract Manufacturing
The Saar Biotech Advantage
At Saar Biotech, we manufacture Ofloxacin + Tinidazole Suspension using a controlled oral suspension manufacturing process that ensures dose uniformity, palatability, and packaging reliability.
- Two-API Suspension Uniformity: Both Ofloxacin and Tinidazole must be uniformly distributed to ensure consistent dosing. Our high-shear mixing and validated fill procedures ensure every 5ml dose delivers the full label claim.
- Taste Masking: Both APIs have bitter profiles requiring expert taste-masking. We develop mango and mixed fruit-flavoured suspension bases that effectively mask bitterness.
- pH and Stability Management: Both actives remain chemically stable for 24 months under tropical storage conditions.
- 60ml Pack Coverage: From dark amber bottles to drip-off embossed cartons and company-logo printed caps — our packaging options help anti-diarrhoeal brands stand out.
Pan-India Supply & Contract Manufacturing
Key Indications & Clinical Use
Ofloxacin + Tinidazole Suspension is manufactured and supplied by Saar Biotech for the following established clinical indications:
- Acute Diarrhoea: Treatment of infectious diarrhoea caused by susceptible organisms
- Dysentery: Management of bloody diarrhoea with bacterial/protozoal aetiology
- Amoebiasis: Treatment of Entamoeba histolytica infection
- Giardiasis: Treatment of Giardia lamblia infection
- Bacterial Gastroenteritis: Management of bacterial gastrointestinal infections
Schedule H — Requires valid medical prescription. Complete full course of therapy.
Pan-India Supply & Contract Manufacturing
Mechanism of Action & Manufacturing Integrity
Two-Component Clinical Mechanism
Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, preventing bacterial DNA replication and transcription. It is effective against a wide range of Gram-negative and Gram-positive bacteria.
Tinidazole 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.
Manufacturing Integrity
- Two-API Suspension Uniformity: Both actives must be uniformly distributed. Our suspending agent system ensures consistent dispersion.
- pH and Stability Management: The suspension vehicle is pH-buffered to maintain both actives’ chemical stability for 24 months.
- Taste Masking: Our flavour systems are engineered to mask the bitter profiles of both APIs.
Pan-India Supply & Contract Manufacturing
Pharmacokinetics & B2B Commercial Value
- Rapid Absorption: Ofloxacin and Tinidazole are well absorbed from the GI tract, with Tmax typically achieved within 1–3 hours.
- Broad Prescriber Base: Used across gastroenterology, paediatrics, and general medicine — wide prescriber reach.
- Seasonal Demand: Consistent demand during monsoon and gastrointestinal illness seasons.
- 60ml Pack Logic: The 60ml format provides a convenient supply for 3–5 day treatment courses.
Pan-India Supply & Contract Manufacturing
B2B & Contract Manufacturing Details
Saar Biotech provides Third-Party Manufacturing and Contract Manufacturing for Ofloxacin + Tinidazole Suspension from our dedicated oral suspension manufacturing facility in Baddi, Himachal Pradesh.
- Facility: Oral suspension manufacturing area with controlled processing, automated bottle filling, capping, labelling, and carton packing lines.
- Capacity: Scalable from brand-entry launches to large commercial batches; 160×60ml distributor dispatch configurations available.
- Quality Lab: In-house GLP-certified lab with validated HPLC assay for both actives, plus pH, viscosity, MLT, and fill volume checks.
- Turnaround: New orders — 30 to 45 working days. Repeat orders — 20 to 25 working days.
- Packaging: 60ml PET or dark amber bottles; sticker label, metallic label, measuring cup, printed cap, with/without carton.
- MOQ: Starting at 5,000–10,000 units per SKU.
Pan-India Supply & Contract Manufacturing
Storage & Handling Guidelines
- Warehouse Conditions: Store below 30°C in a cool, dry environment. Do not freeze.
- Shake Well Before Every Dose: Critical for uniform API distribution.
- Measuring Cup Use: A calibrated measuring cup ensures accurate dosing.
- Light Protection: Dark amber bottles and outer cartons protect from light-induced degradation.
Pan-India Supply & Contract Manufacturing
Quality Control & Compliance
Every commercial batch is quarantined until it passes a comprehensive analytical release protocol:
- Two-API HPLC Assay: Simultaneous quantification of Ofloxacin and Tinidazole against IP specifications.
- Suspension Uniformity & Re-Dispersibility: Sediment behaviour and post-shaking uniformity are evaluated.
- pH & Viscosity Testing: The suspension’s pH and flow characteristics are monitored.
- Microbial Limit Testing (MLT): IP-compliant microbiological testing.
- Certificate of Analysis (COA): Issued with every B2B batch.
Pan-India Supply & Contract Manufacturing
Safety Profile & Precautions
- Arthropathy Risk (Ofloxacin): Ofloxacin is generally not recommended for children under 18 years except for specific indications.
- Neurological Effects (Tinidazole): May cause peripheral neuropathy with prolonged use.
- Contraindications: Hypersensitivity to fluoroquinolones or nitroimidazoles; blood dyscrasias; first trimester of pregnancy.
- Drug Interactions: Avoid alcohol during and for 3 days after Tinidazole therapy.
For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Ofloxacin + Tinidazole Suspension, please use the B2B enquiry form below.
Pan-India Supply & Contract Manufacturing
Clinical Q&A for Ofloxacin + Tinidazole Suspension
Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.
What are the clinical indications for Ofloxacin + Tinidazole Suspension?
How do Ofloxacin and Tinidazole work together?
What is the standard dosing protocol for this suspension?
What are the key contraindications and precautions?
What are the common side effects of this combination?
B2B Manufacturing Guide for Ofloxacin + Tinidazole Suspension
Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.
