Cefixime + Ofloxacin Dry Syrup
Cefixime Trihydrate IP eq. to Cefixime 50mg + Ofloxacin IP 50mg Dry Syrup · Antibiotics, Pediatric Care, Infectious Diseases
WHO-GMP
DCGI Approved
Baddi, HP
Active Pharma Composition
DRY SYRUP PRESENTATION (50mg + 50mg):
Each 5 ml of reconstituted suspension contains:
Cefixime Trihydrate IP eq. to Cefixime
50 mg
Ofloxacin IP
50 mg
Flavoured Syrupy Base
q.s.
DRY SYRUP PRESENTATION (100mg + 100mg):
Each 5 ml of reconstituted suspension contains:
Cefixime Trihydrate IP eq. to Cefixime
100 mg
Ofloxacin IP
100 mg
Flavoured Syrupy Base
q.s.
Product Data Sheet
Segments & Ranges
Dry Syrups / Suspensions / Oral Liquids
Dosage Form
Dry Syrup for Oral Suspension
Pharma Class
Antibiotics / Pediatric Care / Infectious Diseases
Pack Sizes
30 ml / 60 ml
Storage Condition
Store below 30°C in a cool, dry place. Protect from direct sunlight. After reconstitution, refrigerate and discard after 7 days.
Stability / Shelf Life
24 Months
Manufacturing Location
Baddi, Himachal Pradesh
Compliance
DCGI Approved / Schedule M
Available Strengths
Cefixime 50mg + Ofloxacin 50mg | Cefixime 100mg + Ofloxacin 100mg per 5ml
Flavor Options
Mango and Mixed Fruit — preferred for pediatric antibiotic dry syrups
Pack Options
30ml & 60ml — sticker 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
Cefixime + Ofloxacin Dry Syrup is a potent dual-antibiotic formulation indicated for pediatric respiratory and gastrointestinal infections. As a premier WHO-GMP certified pharmaceutical manufacturer in Baddi, Saar Biotech manufactures this dry syrup with validated two-API quality control and precise reconstitution properties, ensuring reliable antibiotic 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
Cefixime + Ofloxacin Dry Syrup belongs to the Dry Syrups and Suspensions categories within the Antibiotics and Pediatric Care therapeutic segments.
- Cefixime 50mg/100mg — third-generation cephalosporin effective against Gram-positive and Gram-negative bacteria
- Ofloxacin 50mg/100mg — fluoroquinolone antibiotic with broad-spectrum antibacterial activity
For pharmaceutical marketing companies, this is a high-prescription pediatric antibiotic product with consistent demand. Saar Biotech manufactures it 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 Cefixime + Ofloxacin Dry Syrup using a controlled dry syrup manufacturing process that ensures dose uniformity and reconstitution reliability.
- Dry Powder Uniformity: Both actives are uniformly distributed in the dry powder blend.
- Reconstitution Properties: Rapid reconstitution with water ensures consistent suspension.
- Taste Masking: Mango and mixed fruit flavours effectively mask antibiotic bitterness.
- pH and Stability Management: Both actives remain chemically stable for 24 months.
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 dry syrup is manufactured and supplied by Saar Biotech for the following established clinical indications:
- Respiratory Tract Infections: Acute bronchitis, tonsillitis, and pharyngitis
- Urinary Tract Infections: Treatment of UTI in pediatric patients
- Gastrointestinal Infections: Enteric infections and bacterial diarrhoea
- Skin and Soft Tissue Infections: Bacterial skin infections in children
Schedule H — Requires valid medical prescription. Complete full course of therapy.
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
Cefixime inhibits bacterial cell wall synthesis, causing cell lysis. Ofloxacin inhibits bacterial DNA gyrase, preventing DNA replication.
Manufacturing Integrity
- Dry Powder Uniformity: Both actives are uniformly distributed in the dry powder blend.
- Reconstitution Stability: The reconstituted suspension remains stable for 7 days.
- pH Stability: The dry powder vehicle maintains 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 Cefixime + Ofloxacin Dry Syrup from our dedicated dry syrup manufacturing facility in Baddi, Himachal Pradesh.
- Facility: Dry syrup manufacturing area with automated powder blending and bottle filling.
- Capacity: Scalable from brand-entry launches to large commercial batches.
- Quality Lab: In-house GLP-certified lab with HPLC assay, pH, MLT, and reconstitution studies.
- Turnaround: New orders — 30 to 45 working days. Repeat orders — 20 to 25 working days.
- Packaging: 30ml and 60ml PET or glass bottles; sticker 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. Protect from direct sunlight.
- Reconstitution Instructions: Add purified water to the powder and shake well until completely suspended.
- Post-Reconstitution: Refrigerate and discard after 7 days.
- Shake Well Before Every Dose: Critical for uniform API distribution.
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 Cefixime and Ofloxacin.
- Reconstitution Studies: Suspension uniformity and re-dispersibility testing.
- pH Testing: Verification of pH within stability-appropriate specification range.
- 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.
- Allergic Reactions: Cross-hypersensitivity between cephalosporins and penicillins.
- Contraindications: Hypersensitivity to cephalosporins or fluoroquinolones.
For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Cefixime + Ofloxacin Dry Syrup, 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 Cefixime + Ofloxacin Dry Syrup
Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.
What are the clinical indications for Cefixime + Ofloxacin Dry Syrup?
This combination dry syrup is indicated for the treatment of pediatric respiratory and gastrointestinal infections caused by susceptible organisms. Cefixime provides broad-spectrum cephalosporin coverage, while Ofloxacin addresses bacterial infections. The combination is effective for acute bronchitis, tonsillitis, urinary tract infections, and enteric infections in children.
How do Cefixime and Ofloxacin work together?
Cefixime inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins, preventing cross-linking of peptidoglycan and causing bacterial cell lysis. Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, preventing DNA replication. Together, they provide synergistic coverage against a broad spectrum of Gram-positive and Gram-negative organisms.
What is the standard dosing protocol for pediatric patients?
The standard pediatric dose is weight-based, typically 5–10 mg/kg/day of Cefixime and 5–10 mg/kg/day of Ofloxacin in divided doses twice daily. For children aged 5–12 years, the typical dose is 5 ml twice daily. The dry syrup should be reconstituted with purified water as directed and shaken well before each use. Treatment duration is usually 5–7 days.
What is the shelf life after reconstitution?
After reconstitution with purified water, the dry syrup remains stable for 7 days when stored below 25°C or refrigerated at 2°C–8°C. Patients should be advised to discard any unused portion after 7 days. The bottle should be shaken well before each use.
What are the key contraindications and precautions?
This combination is contraindicated in patients with known hypersensitivity to cephalosporins, fluoroquinolones, or any component. Caution is advised in patients with renal impairment, hepatic impairment, and those with a history of gastrointestinal disease. Ofloxacin is generally not recommended for children under 18 years except for specific indications.
Manufacturing Support
B2B Manufacturing Guide for Cefixime + Ofloxacin Dry Syrup
Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.
What pack sizes and packaging options are available for Cefixime Ofloxacin Dry Syrup?
Saar Biotech manufactures Cefixime + Ofloxacin Dry Syrup in 30 ml and 60 ml bottle formats. The 30 ml pack is the primary commercial format for pediatric dry syrups. Packaging options include: sticker 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 dry syrup?
Standard MOQ ranges from 5,000 to 10,000 units per SKU, depending on bottle size, label type, and carton format. This antibiotic combination has consistent demand, particularly in pediatric infections, and our automated dry syrup filling lines in Baddi support both brand-entry volumes and large commercial runs.
What analytical tests are performed on every manufacturing batch?
Every batch undergoes HPLC Assay confirming Cefixime and Ofloxacin content against IP specifications. Reconstitution studies and suspension uniformity testing ensures dose consistency. pH testing, viscosity measurement, 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 and DCGI approval?
Yes. Our regulatory team provides end-to-end support for DCGI brand name search and approval for antibiotic products.
What packaging and design support does Saar Biotech provide for private-label Cefixime Ofloxacin Dry Syrup?
Saar Biotech offers comprehensive in-house artwork services for dry syrup products, including mono-carton design, label design, foil layout, and measuring cup specification. All packaging elements are reviewed for DCGI labelling compliance under Schedule M, covering mandatory ingredients disclosure, storage conditions, and paediatric dosing schedule requirements for this combination antibiotic product.
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