Cetirizine Dihydrochloride Syrup
Cetirizine Dihydrochloride IP 5mg/5ml Oral Syrup · Anti-Histamines, Cough & Cold, Pediatric Care
WHO-GMP
DCGI Approved
Baddi, HP
Active Pharma Composition
SYRUP PRESENTATION:
Each 5 ml contains:
Cetirizine Dihydrochloride IP
5 mg
Flavoured Syrupy Base
q.s.
Product Data Sheet
Segments & Ranges
Syrups / Oral Liquids
Dosage Form
Oral Syrup
Pharma Class
Anti-Histamines / Cough & Cold / Pediatric Care
Pack Sizes
30 ml / 60 ml
Storage Condition
Store below 30°C in a cool, dry place. Protect from direct sunlight. Keep tightly closed.
Stability / Shelf Life
24 Months
Manufacturing Location
Baddi, Himachal Pradesh
Compliance
DCGI Approved / Schedule M
Flavor Options
Mixed Fruit, Strawberry, and Orange — preferred for pediatric syrups
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
Cetirizine Dihydrochloride 5mg/5ml Syrup is a non-sedating antihistamine indicated for allergic rhinitis, urticaria, and allergic skin conditions. As a premier WHO-GMP certified pharmaceutical manufacturer in Baddi, Saar Biotech manufactures this syrup with precise API assay control and validated taste-masking.
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
Cetirizine Syrup belongs to the Syrups category within the Anti-Histamines, Cough & Cold, and Pediatric Care therapeutic segments.
Saar Biotech manufactures this syrup 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 Cetirizine Syrup using a controlled oral syrup manufacturing process that ensures dose uniformity and palatability.
- API Uniformity: Cetirizine is uniformly distributed for consistent dosing.
- Taste Masking: Mixed fruit, strawberry, and orange flavours ensure patient acceptance.
- pH and Stability Management: The active remains chemically stable for 24 months.
- 30ml and 60ml Pack Coverage: Suitable for pediatric and adult allergy management.
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 syrup is manufactured and supplied by Saar Biotech for the following established clinical indications:
- Seasonal Allergic Rhinitis: Relief from pollen allergy symptoms
- Perennial Allergic Rhinitis: Year-round allergy relief
- Chronic Idiopathic Urticaria: Reduction of itching and hives
- Allergic Skin Conditions: Relief from allergic dermatitis and pruritus
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
Cetirizine competitively blocks H1 histamine receptors, preventing histamine-induced vasodilation, capillary permeability, and sensory nerve stimulation.
Manufacturing Integrity
- pH Stability: The syrup base is pH-buffered to maintain active stability.
- Taste Masking: Effective taste-masking ensures patient compliance.
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 Cetirizine Syrup from our oral liquid manufacturing facility in Baddi, Himachal Pradesh.
- Facility: Oral liquid 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. Protect from direct sunlight.
- Light Protection: Amber bottles and outer cartons protect from photo-degradation.
- Measuring Cup Use: A calibrated measuring cap ensures accurate dosing.
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 Cetirizine 5mg per 5ml.
- 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
- Low Sedation: Minimal sedation compared to first-generation antihistamines.
- Renal Precautions: Dose adjustment required in renal impairment.
- Contraindications: Known hypersensitivity to any component.
For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Cetirizine 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 Cetirizine Dihydrochloride Syrup
Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.
What are the clinical indications for Cetirizine 5mg Syrup?
Cetirizine Dihydrochloride 5mg/5ml Syrup is indicated for the symptomatic relief of seasonal and perennial allergic rhinitis, chronic idiopathic urticaria, and allergic skin conditions. It is a second-generation antihistamine with low sedation potential, making it suitable for daytime use in both adults and children.
How does Cetirizine work as an antihistamine?
Cetirizine is a selective H1 receptor antagonist that competitively blocks histamine from binding to H1 receptors on respiratory smooth muscle and capillary endothelial cells. This prevents histamine-induced vasodilation, capillary permeability, and sensory nerve stimulation that causes sneezing, rhinorrhea, and pruritus.
What is the standard dosing protocol?
For adults and children over 12 years, the typical dose is 5 to 10 ml (5–10mg) once daily. For children aged 6 to 12 years, the dose is 5 ml (5mg) twice daily. For children aged 2 to 6 years, the dose is 2.5ml (2.5mg) twice daily. Dosing should always follow the physician’s prescription.
What are the key precautions for Cetirizine?
Cetirizine is generally well-tolerated with low sedation potential. Caution is advised in patients with renal impairment, as dose adjustment may be necessary. Use during pregnancy and lactation should be under physician supervision.
What are the common side effects?
Common side effects may include mild drowsiness, dry mouth, headache, and fatigue. These are typically mild and transient. Unlike first-generation antihistamines, Cetirizine has significantly less sedation.
Manufacturing Support
B2B Manufacturing Guide for Cetirizine Dihydrochloride Syrup
Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.
What pack sizes and packaging options are available for Cetirizine Syrup?
Saar Biotech manufactures Cetirizine 5mg/5ml Syrup 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 Cetirizine Syrup?
Standard MOQ ranges from 5,000 to 10,000 units per SKU, depending on bottle size, label type, and carton format. This antihistamine syrup has consistent year-round demand.
What analytical tests are performed on every manufacturing batch?
Every batch undergoes HPLC Assay confirming Cetirizine content, 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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