Cetirizine + Ambroxol Syrup
Cetirizine Hydrochloride IP 2.5mg + Ambroxol Hydrochloride IP 30mg Oral Syrup · Cough & Cold, Anti-Histamines, Respiratory
SYRUP PRESENTATION:
Product Profile
Cetirizine + Ambroxol Syrup is a clinically established, dual-action formulation indicated for allergic respiratory conditions associated with thick mucus. As a premier WHO-GMP certified pharmaceutical manufacturer in Baddi, Saar Biotech manufactures this syrup with validated two-API quality control and precise taste-masking, ensuring reliable therapeutic 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
Description & Therapeutic Class
Cetirizine + Ambroxol Syrup belongs to the Syrups category within the Cough & Cold, Anti-Histamines, and Respiratory therapeutic segments.
- Cetirizine 2.5mg — second-generation antihistamine for allergy symptom relief
- Ambroxol 30mg — mucolytic for thinning and loosening phlegm
For pharmaceutical marketing companies, this is a high-prescription respiratory product with consistent demand. Saar Biotech manufactures it from our manufacturing facility in Baddi.
Pan-India Supply & Contract Manufacturing
The Saar Biotech Advantage
At Saar Biotech, we manufacture Cetirizine + Ambroxol Syrup using a controlled oral syrup manufacturing process that ensures dose uniformity and palatability.
- Two-API Uniformity: Both actives are uniformly distributed for consistent dosing.
- Taste Masking: Palatable syrup base ensures patient acceptance.
- pH and Stability Management: Both actives remain chemically stable for 24 months.
- 60ml and 100ml Pack Coverage: Suitable for short and extended treatment courses.
Pan-India Supply & Contract Manufacturing
Key Indications & Clinical Use
This syrup is manufactured and supplied by Saar Biotech for the following established clinical indications:
- Allergic Rhinitis: Relief from sneezing, runny nose, and watery eyes
- Bronchitis: Management of productive cough with mucus production
- Cough with Mucus: Symptomatic relief of cough associated with thick phlegm
- Allergic Respiratory Conditions: Comprehensive management of allergy-related respiratory symptoms
Schedule H — Requires valid medical prescription.
Pan-India Supply & Contract Manufacturing
Mechanism of Action & Manufacturing Integrity
Cetirizine competitively blocks H1 histamine receptors, reducing histamine-mediated symptoms. Ambroxol breaks down mucus, making it easier to expectorate.
Manufacturing Integrity
- Two-API Compatibility: Both actives remain stable in the syrup vehicle.
- pH Stability: The syrup base is pH-buffered to maintain active stability.
Pan-India Supply & Contract Manufacturing
B2B & Contract Manufacturing Details
Saar Biotech provides Third-Party Manufacturing for Cetirizine + Ambroxol 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: 60ml and 100ml 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.
- 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
Quality Control & Compliance
Every commercial batch is quarantined until it passes a comprehensive analytical release protocol:
- Two-API HPLC Assay: Simultaneous quantification of Cetirizine and Ambroxol.
- pH Testing: Verification of pH within specification range.
- 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
- Sedation: Cetirizine may cause mild drowsiness; avoid alcohol and driving.
- 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 + Ambroxol Syrup, please use the B2B enquiry form below.
Pan-India Supply & Contract Manufacturing
Clinical Q&A for Cetirizine + Ambroxol Syrup
Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.
What are the clinical indications for Cetirizine + Ambroxol Syrup?
How does this combination work?
What is the standard dosing protocol?
What are the key contraindications and precautions?
What are the common side effects?
B2B Manufacturing Guide for Cetirizine + Ambroxol Syrup
Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.

