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.

Manufacturing Advantage

Why Saar Biotech for Roxithromycin Oral Suspension?

Since {{ site.Params.founded }}, Saar Biotech has been a distinguished WHO-GMP certified leader in pharmaceutical manufacturing. We utilize advanced micronization and pH-stabilization protocols to deliver unmatched bioavailability for this Roxithromycin Oral Suspension formulation.

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
Medical Intelligence

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?

Roxithromycin Oral Suspension is indicated for the treatment of respiratory tract infections, skin and soft tissue infections, and other bacterial infections caused by susceptible organisms. It is a macrolide antibiotic with activity against Gram-positive bacteria and some Gram-negative organisms.

How does Roxithromycin work as an antibiotic?

Roxithromycin binds to the 50S ribosomal subunit of bacteria, inhibiting protein synthesis. This bacteriostatic action prevents bacterial growth and allows the immune system to clear the infection. It has enhanced acid stability and tissue penetration compared to erythromycin.

What is the standard dosing protocol?

The standard dose for children is 5 to 8 mg/kg/day in divided doses twice daily. The suspension should be shaken well before each use. Treatment duration is usually 5 to 10 days.

What are the key contraindications and precautions?

Roxithromycin is contraindicated in patients with known hypersensitivity to macrolides. Caution is advised in patients with hepatic impairment, QT prolongation, and those taking other QT-prolonging medications.

What are the common side effects?

Common side effects may include nausea, abdominal pain, diarrhoea, vomiting, and headache. Most of these are mild and transient.
Manufacturing Support

B2B Manufacturing Guide for Roxithromycin Oral Suspension

Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.

What pack sizes and packaging options are available for Roxithromycin Suspension?
Saar Biotech manufactures Roxithromycin 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 Roxithromycin Suspension?
Standard MOQ ranges from 5,000 to 10,000 units per SKU, depending on bottle size, label type, and carton format.
What analytical tests are performed on every manufacturing batch?
Every batch undergoes HPLC Assay confirming Roxithromycin content, suspension uniformity testing, pH and viscosity testing, and Microbial Limit Testing (MLT). A Certificate of Analysis (COA) is issued.
What is the turnaround time for a new order?
Initial third-party production typically requires 30 to 45 working days following packaging confirmation. Repeat orders are fulfilled in 20–25 working days.
Does Saar Biotech provide export manufacturing services for this product?
Yes. In addition to domestic third-party manufacturing, our WHO-GMP certified facility supports export manufacturing. We assist with required documentation including COPP (Certificate of Pharmaceutical Product) and FSC (Free Sale Certificate) for international markets.
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