Amoxicillin Oral Suspension
Amoxicillin Trihydrate IP eq. to Amoxicillin 125mg/5ml Oral Suspension · Antibiotics, Pediatric Care, Infectious Diseases
WHO-GMP
DCGI Approved
Baddi, HP
Active Pharma Composition
SUSPENSION PRESENTATION (125mg):
Each 5 ml contains:
Amoxicillin Trihydrate IP eq. to Amoxicillin
125 mg
Flavoured Suspension Base
q.s.
SUSPENSION PRESENTATION (250mg):
Each 5 ml contains:
Amoxicillin Trihydrate IP eq. to Amoxicillin
250 mg
Flavoured Suspension Base
q.s.
Product Data Sheet
Segments & Ranges
Suspensions / Oral Liquids
Dosage Form
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. Do not freeze. Shake well before every use.
Stability / Shelf Life
24 Months
Manufacturing Location
Baddi, Himachal Pradesh
Compliance
DCGI Approved / Schedule M
Manufacturing Block
Dedicated Beta-Lactam Block
Available Strengths
Amoxicillin 125mg/5ml | Amoxicillin 250mg/5ml
Flavor Options
Strawberry, Mixed Fruit, and Orange — preferred for pediatric suspensions
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
Amoxicillin 125mg/5ml Oral Suspension is a broad-spectrum penicillin antibiotic indicated for various bacterial infections. As a premier WHO-GMP certified pharmaceutical manufacturer in Baddi, Saar Biotech manufactures this suspension in our dedicated beta-lactam block 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
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
Description & Therapeutic Class
Amoxicillin 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 in a dedicated, segregated Beta-Lactam block to prevent cross-contamination.
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 Amoxicillin Suspension using a controlled oral suspension manufacturing process that ensures dose uniformity and palatability.
- API Uniformity: Amoxicillin is uniformly suspended for consistent dosing.
- Taste Masking: Strawberry 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
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:
- Respiratory Tract Infections: Bronchitis, pneumonia, sinusitis
- Otitis Media: Middle ear infections in children
- Urinary Tract Infections: Cystitis, pyelonephritis
- Skin and Soft Tissue Infections: Bacterial skin infections
- Dental Infections: Tooth abscess and gum infections
Schedule H — Requires valid medical prescription.
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
Amoxicillin inhibits bacterial cell wall synthesis, causing cell lysis and death.
Manufacturing Integrity
- Beta-Lactam Block: Manufactured in a dedicated segregated area to prevent cross-contamination.
- Suspension Uniformity: Amoxicillin is uniformly suspended for consistent dosing.
- pH Stability: 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 Amoxicillin Suspension from our dedicated beta-lactam oral suspension manufacturing facility in Baddi, Himachal Pradesh.
- Facility: Dedicated beta-lactam block 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:
- HPLC Assay: Quantification of Amoxicillin content.
- 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
- Allergic Reactions: Risk of hypersensitivity in penicillin-allergic patients.
- Gastrointestinal Effects: Diarrhoea, nausea, vomiting.
- Contraindications: Known hypersensitivity to penicillins or cephalosporins.
For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Amoxicillin 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 Amoxicillin Oral Suspension
Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.
What are the clinical indications for Amoxicillin Oral Suspension?
Amoxicillin Oral Suspension is indicated for the treatment of infections caused by susceptible organisms, including respiratory tract infections, otitis media, sinusitis, urinary tract infections, skin and soft tissue infections, and dental infections. It is a broad-spectrum penicillin antibiotic with excellent activity against Gram-positive and Gram-negative bacteria.
How does Amoxicillin work as an antibiotic?
Amoxicillin inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins. This prevents the cross-linking of peptidoglycan, a critical component of the bacterial cell wall, leading to cell lysis and death. It is bactericidal and effective against a wide range of organisms.
What is the standard dosing protocol?
The standard pediatric dose is 20–40 mg/kg/day in divided doses every 8 hours. For adults, the typical dose is 5 to 10 ml (125–250mg) three times daily. The suspension should be shaken well before each use and treatment should continue for 7 to 10 days.
What are the key contraindications and precautions?
Amoxicillin is contraindicated in patients with known hypersensitivity to penicillins or cephalosporins. Caution is advised in patients with renal impairment, gastrointestinal disease, and those with a history of allergic reactions. Use during pregnancy and lactation should be under physician supervision.
What are the common side effects?
Common side effects may include diarrhoea, nausea, vomiting, rash, and abdominal pain. Most of these are mild and transient. Patients should be advised to complete the full course of antibiotic therapy.
Manufacturing Support
B2B Manufacturing Guide for Amoxicillin Oral Suspension
Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.
What pack sizes and packaging options are available for Amoxicillin Suspension?
Saar Biotech manufactures Amoxicillin Suspension in 30 ml and 60 ml bottle formats. Both 125mg/5ml and 250mg/5ml strengths are available. 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 Amoxicillin Suspension?
Standard MOQ ranges from 5,000 to 10,000 units per SKU, depending on bottle size and strength. This penicillin suspension has consistent demand in pediatric infections.
What analytical tests are performed on every manufacturing batch?
Every batch undergoes HPLC Assay confirming Amoxicillin 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.
Do you offer private labelling and packaging design?
Yes, our in-house design team provides end-to-end support for private label packaging, including mono-cartons, labels, and promotional materials compliant with regulatory guidelines.
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