Roxithromycin Oral Suspension
Roxithromycin IP 50mg/5ml Oral Suspension · Antibiotics, Pediatric Care, Infectious Diseases
SUSPENSION PRESENTATION:
Product Profile
Roxithromycin 50mg/5ml Oral Suspension is a macrolide antibiotic indicated for respiratory and skin infections. As a premier WHO-GMP certified pharmaceutical manufacturer in Baddi, Saar Biotech manufactures this suspension with validated API quality control.
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
Roxithromycin Oral Suspension belongs to the Suspensions category within the Antibiotics, Pediatric Care, and Infectious Diseases therapeutic segments.
Saar Biotech manufactures this suspension from our manufacturing facility in Baddi.
Pan-India Supply & Contract Manufacturing
The Saar Biotech Advantage
At Saar Biotech, we manufacture Roxithromycin Suspension using a controlled oral suspension manufacturing process that ensures dose uniformity and palatability.
- API Uniformity: Roxithromycin is uniformly suspended for consistent dosing.
- Taste Masking: Mango and mixed fruit flavours mask the bitter taste.
- pH and Stability Management: The active remains chemically stable for 24 months.
- 30ml and 60ml Pack Coverage: Suitable for pediatric and adult treatment courses.
Pan-India Supply & Contract Manufacturing
Key Indications & Clinical Use
This suspension is manufactured and supplied by Saar Biotech for the following established clinical indications:
- Respiratory Tract Infections: Bronchitis, pneumonia, pharyngitis
- Skin and Soft Tissue Infections: Bacterial skin infections
- ENT Infections: Sinusitis, otitis media
Schedule H — Requires valid medical prescription.
Pan-India Supply & Contract Manufacturing
Mechanism of Action & Manufacturing Integrity
Roxithromycin binds to the 50S ribosomal subunit, inhibiting protein synthesis and bacterial growth.
Manufacturing Integrity
- Suspension Uniformity: Roxithromycin is uniformly suspended for consistent dosing.
- pH Stability: The suspension vehicle is pH-buffered to maintain active stability.
Pan-India Supply & Contract Manufacturing
B2B & Contract Manufacturing Details
Saar Biotech provides Third-Party Manufacturing for Roxithromycin 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
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:
- HPLC Assay: Quantification of Roxithromycin 50mg per 5ml.
- 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
Safety Profile & Precautions
- Gastrointestinal Effects: Nausea, abdominal pain, diarrhoea.
- Cardiac Effects: QT prolongation; use with caution with other QT-prolonging drugs.
- Contraindications: Hypersensitivity to macrolides.
For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Roxithromycin Suspension, please use the B2B enquiry form below.
Pan-India Supply & Contract Manufacturing
Clinical Q&A for Roxithromycin Oral Suspension
Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.
What are the clinical indications for Roxithromycin Oral Suspension?
How does Roxithromycin work as an antibiotic?
What is the standard dosing protocol?
What are the key contraindications and precautions?
What are the common side effects?
B2B Manufacturing Guide for Roxithromycin Oral Suspension
Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.
