Ofloxacin + Ornidazole Suspension
Ofloxacin IP 50mg + Ornidazole IP 125mg Oral Suspension · Antibiotics, Gastroenterology, Anti-Infectives
WHO-GMP
DCGI Approved
Baddi, HP
Active Pharma Composition
SUSPENSION PRESENTATION:
Each 5 ml contains:
Ofloxacin IP
50 mg
Ornidazole IP
125 mg
Flavoured Suspension Base
q.s.
Product Data Sheet
Segments & Ranges
Suspensions / Oral Liquids
Dosage Form
Oral Suspension
Pharma Class
Antibiotics / Gastroenterology / Anti-Infectives
Pack Sizes
30 ml / 60 ml
Storage Condition
Store below 30°C in a cool, dry place. Protect from direct sunlight. Do not freeze. Shake well before every use.
Stability / Shelf Life
24 Months
Manufacturing Location
Baddi, Himachal Pradesh
Compliance
DCGI Approved / Schedule M
Pack Options
30ml & 60ml — sticker label, metallic label, drip-off embossed carton, measuring cap, printed cap, with/without carton
Batch Size
5,000 to 2,00,000+ Units
Schedule M Compliant
Private Label Ready
Pan-India Dispatch
WHO-GMP
ISO 9001:2015
GLP Certified
DCGI Approved
Schedule M
Product Profile
Ofloxacin + Ornidazole Suspension is a broad-spectrum antimicrobial formulation indicated for gastrointestinal infections. 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
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
Description & Therapeutic Class
Ofloxacin + Ornidazole Suspension belongs to the Suspensions category within the Antibiotics, Gastroenterology, and Anti-Infectives therapeutic segments.
- Ofloxacin 50mg — fluoroquinolone antibiotic effective against Gram-negative and Gram-positive bacteria
- Ornidazole 125mg — nitroimidazole effective against anaerobic bacteria and protozoa
Saar Biotech manufactures this suspension from our manufacturing facility in Baddi.
Pan-India Supply & Contract Manufacturing
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
The Saar Biotech Advantage
At Saar Biotech, we manufacture Ofloxacin + Ornidazole Suspension using a controlled oral suspension manufacturing process that ensures dose uniformity, palatability, and packaging reliability.
- Two-API Suspension Uniformity: Both actives are uniformly distributed.
- Taste Masking: Mango and mixed fruit flavours mask bitter notes.
- pH and Stability Management: Both actives remain chemically stable for 24 months.
- 30ml and 60ml Pack Coverage: Suitable for pediatric and adult treatment courses.
Pan-India Supply & Contract Manufacturing
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
Key Indications & Clinical Use
This suspension is manufactured and supplied by Saar Biotech for the following established clinical indications:
- Acute Diarrhoea: Treatment of infectious diarrhoea
- Dysentery: Management of bloody diarrhoea
- Amoebiasis: Treatment of Entamoeba histolytica infection
- Giardiasis: Treatment of Giardia lamblia infection
- Bacterial Gastroenteritis: Management of bacterial gastrointestinal infections
Pan-India Supply & Contract Manufacturing
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
Mechanism of Action & Manufacturing Integrity
Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV. Ornidazole is reduced to toxic free radicals that damage microbial DNA.
Manufacturing Integrity
- Two-API Suspension Uniformity: Both actives are uniformly suspended for consistent dosing.
- pH and Stability Management: The suspension vehicle is pH-buffered to maintain active stability.
Pan-India Supply & Contract Manufacturing
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
B2B & Contract Manufacturing Details
Saar Biotech provides Third-Party Manufacturing for Ofloxacin + Ornidazole Suspension from our 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.
- Quality Lab: In-house GLP-certified lab with HPLC assay, pH, viscosity, 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, measuring cup, printed cap.
- MOQ: Starting at 5,000–10,000 units per SKU.
Pan-India Supply & Contract Manufacturing
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
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
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
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 Ornidazole.
- Suspension Uniformity: Sediment behaviour and re-dispersibility testing.
- pH & Viscosity Testing: Suspension stability monitoring.
- Microbial Limit Testing (MLT): IP-compliant microbiological testing.
- Certificate of Analysis (COA): Issued with every B2B batch.
Pan-India Supply & Contract Manufacturing
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
Safety Profile & Precautions
- Arthropathy Risk: Ofloxacin not recommended for children under 18 years except specific indications.
- Neurological Effects: Ornidazole may cause peripheral neuropathy with prolonged use.
- Contraindications: Hypersensitivity to fluoroquinolones or nitroimidazoles; blood dyscrasias; first trimester of pregnancy.
For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Ofloxacin + Ornidazole Suspension, please use the B2B enquiry form below.
Pan-India Supply & Contract Manufacturing
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
Medical Intelligence
Clinical Q&A for Ofloxacin + Ornidazole Suspension
Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.
What are the clinical indications for Ofloxacin + Ornidazole Suspension?
This combination suspension is indicated for the treatment of gastrointestinal infections, including diarrhoea and dysentery caused by susceptible bacteria and protozoa. Ofloxacin provides broad-spectrum antibacterial coverage, while Ornidazole is effective against anaerobic bacteria and protozoa including Giardia lamblia and Entamoeba histolytica. The suspension form enables accurate dosing in paediatric patients.
How do Ofloxacin and Ornidazole work together?
Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, preventing DNA replication and transcription. Ornidazole enters microbial cells and is reduced to toxic free radicals that damage DNA. Together, they provide synergistic broad-spectrum coverage against both bacterial and protozoal pathogens.
What is the standard dosing protocol?
The standard adult dose is 10 ml (delivering Ofloxacin 100mg + Ornidazole 250mg) taken twice daily for 3 to 5 days. For pediatric patients, dosing should be calculated based on body weight. The suspension should be shaken well before each dose.
What are the key contraindications and precautions?
This suspension is contraindicated in patients with known hypersensitivity to fluoroquinolones or nitroimidazoles. Ofloxacin is generally not recommended for children under 18 years except for specific indications. Ornidazole is contraindicated in patients with blood dyscrasias and during the first trimester of pregnancy.
What are the common side effects?
Common side effects may include nausea, vomiting, abdominal pain, diarrhoea, headache, and dizziness. These are typically mild and transient. Patients should be advised to complete the full course of antibiotic therapy.
Manufacturing Support
B2B Manufacturing Guide for Ofloxacin + Ornidazole Suspension
Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.
What pack sizes and packaging options are available for this suspension?
Saar Biotech manufactures Ofloxacin + Ornidazole Suspension in 30 ml and 60 ml bottle formats. Packaging options include: sticker label, metallic label, drip-off brand embossed carton, measuring cap, printed cap, company-logo printed PP cap, with-carton or without-carton supply.
What is the MOQ for this suspension?
Commercial manufacturing usually requires an MOQ of 5,000 to 10,000 units, depending on bottle size, label type, and carton format.
What analytical tests are performed on every batch?
Every batch undergoes HPLC Assay confirming Ofloxacin 50mg and Ornidazole 125mg per 5ml against IP specifications. Suspension uniformity testing, pH and viscosity testing, and Microbial Limit Testing (MLT) confirm product quality. A Certificate of Analysis (COA) is issued with every consignment.
Does Saar Biotech support brand name registration for Ofloxacin + Ornidazole Suspension?
Absolutely. Our in-house regulatory team provides full DCGI brand name search and approval support for combination antibiotics. We are experienced in obtaining product licences for fluoroquinolone + nitroimidazole combinations and guide partners through Schedule H documentation, artwork approval, and regulatory clearances for this category.
What is the turnaround time for a new Ofloxacin + Ornidazole Suspension order?
New third-party manufacturing batches typically ship within 30 to 45 working days of packaging artwork finalisation and regulatory documentation submission. Returning commercial partners with established SKUs benefit from our streamlined repeat order process, with batches dispatched within approximately 20 to 25 working days from Baddi.
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