Promethazine HCl Syrup

Promethazine Syrup belongs to the Syrups category within the Anti-Histamines, Anti-Emetic, and Cough & Cold therapeutic segments.

Saar Biotech manufactures this syrup from our manufacturing facility in Baddi.

At Saar Biotech, we manufacture Promethazine Syrup using a controlled oral syrup manufacturing process that ensures dose uniformity and palatability.

• API Stability: Promethazine is stabilised with appropriate excipients.
• Taste Masking: Palatable syrup base ensures patient acceptance.
• pH and Stability Management: The active remains chemically stable for 24 months.
• 60ml and 100ml Pack Coverage: Suitable for short and extended treatment courses.

This syrup is manufactured and supplied by Saar Biotech for the following established clinical indications:

• Allergic Conditions: Rhinitis, urticaria, angioedema
• Nausea & Vomiting: Prevention and treatment
• Motion Sickness: Prevention and treatment
• Pre- & Post-Operative Sedation: Sedative adjunct
• Common Cold Symptoms: Symptomatic relief of sneezing and rhinorrhea

Schedule H — Requires valid medical prescription. Not for use in children under 2 years.

Promethazine competitively blocks H1 histamine receptors, preventing histamine-induced vasodilation, capillary permeability, and sensory nerve stimulation. Its sedative effects result from central histamine H1 receptor blockade.

Manufacturing Integrity

• Photo-Stability: Amber bottles protect from light degradation.
• pH Stability: The syrup base is pH-buffered to maintain active stability.

Saar Biotech provides Third-Party Manufacturing for Promethazine 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.

1. Warehouse Conditions: Store below 30°C in a cool, dry environment. Protect from direct sunlight.
2. Light Protection: Amber bottles and outer cartons protect from photo-degradation.
3. Measuring Cup Use: A calibrated measuring cup ensures accurate dosing.

Every commercial batch is quarantined until it passes a comprehensive analytical release protocol:

• HPLC Assay: Quantification of Promethazine 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.

• Sedation: Causes significant drowsiness; avoid driving and alcohol.
• Contraindications: Hypersensitivity to phenothiazines; epilepsy, glaucoma, prostatic hypertrophy; children under 2 years.
• Drug Interactions: Potentiates CNS depressants, alcohol, and sedatives.

For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Promethazine Syrup, please use the B2B enquiry form below.