Ambroxol Hydrochloride Oral Drops

Ambroxol Hydrochloride Oral Drops belong to the Oral Drops category within the Respiratory, Cough & Cold, and Pediatric Care therapeutic segments. The oral drops format occupies a distinct and essential role in the pediatric respiratory portfolio — filling the gap between the too-imprecise household teaspoon and the too-large 5ml syrup dosing volume for infants under 2 years of age.

Ambroxol Hydrochloride IP 7.5mg/ml is the pharmacologically active metabolite of bromhexine and the most clinically established secretolytic mucolytic in the Indian pediatric respiratory prescribing landscape. It is the active ingredient in multiple DCGI-approved pediatric respiratory drops formulations available in the Indian market, confirming its regulatory standing for infant use.

Saar Biotech manufactures this formulation at our manufacturing facility in Baddi, Himachal Pradesh, in 15ml dropper bottle format for B2B third-party manufacturing partners supplying paediatricians, general physicians, and hospital pharmacy channels across India.

At Saar Biotech, we manufacture Ambroxol Hydrochloride Oral Drops using a validated precision aqueous liquid compounding process that ensures consistent ambroxol concentration, accurate dropper delivery, and pediatric palatability in every production batch.

• Dropper Delivery Accuracy: The functional performance of the dropper is critical for infant dosing accuracy. Saar Biotech validates dropper nozzle diameter, drop size, and drops-per-ml count during production setup. Each dropper batch is checked for consistent delivery volume before approval.
• pH-Optimized Ambroxol Stability: Ambroxol hydrochloride requires an appropriate pH range to maintain complete solubility and prevent API precipitation or color change on storage. Our formulation’s pH is engineered for maximum stability across the 24-month shelf life in Indian tropical conditions.
• Pediatric Taste Masking: Ambroxol has a slightly bitter organoleptic profile that requires careful flavouring at the small 1ml dose volume. Saar Biotech’s oral drops base includes a pediatric-optimized flavour system that makes administration in infants and toddlers practical for caregiver compliance.
• 15ml Dropper Bottle Execution: The 15ml amber glass or HDPE dropper bottle is the standard pediatric respiratory drops format in India. Saar Biotech’s filling lines are configured for precise 15ml fill with dropper fitment, cap sealing, and label application — supporting branded, private-label, and institutional supply requirements.

Ambroxol Hydrochloride Oral Drops are manufactured and supplied by Saar Biotech for the following DCGI-approved clinical applications in pediatric patients:

• Acute Bronchitis & Bronchiolitis in Infants: Mucolytic clearance support for viscous bronchial secretions in RSV and bacterial lower respiratory tract infections in children under 2 years
• Productive Cough in Toddlers: Secretolytic support for thick mucus associated with post-viral upper and lower respiratory tract catarrh in children aged 1–5 years
• Chronic Respiratory Conditions: Long-term mucokinetic support in children with bronchiectasis, cystic fibrosis (adjunct), or chronic bronchitis with recurrent mucus hypersecretion
• Post-Respiratory Infection Recovery: Accelerating mucus clearance during and after antibiotic treatment courses for pneumonia or bacterial bronchitis
• Neonatal Surfactant Support (Adjunct): Ambroxol’s surfactant-stimulating action is occasionally utilized as adjunct support in premature neonates with surfactant-related respiratory distress, under neonatologist guidance

Schedule H — Requires a valid medical prescription in India.

Clinical Mechanism of Action

Ambroxol acts at multiple levels of the respiratory mucus clearance system:

Serous Gland Stimulation: Ambroxol directly stimulates bronchial gland serous cells to secrete lower-viscosity, watery bronchial fluid. This dilutes the thick, viscous mucus that clogs smaller bronchiolar airways in infants with respiratory infections, reducing airway resistance and breathing work.

Mucociliary Transport Enhancement: Ambroxol increases the beating frequency of bronchial epithelial cilia and improves the ciliary coordination of the mucociliary escalator. The combination of thinned mucus and faster ciliary transport results in dramatically improved mucus clearance efficiency.

Surfactant Synthesis Stimulation: Ambroxol stimulates Type II pneumocytes to produce and secrete pulmonary surfactant (primarily DPPC — dipalmitoylphosphatidylcholine). Increased alveolar surfactant reduces surface tension, prevents alveolar collapse on expiration, and improves gas exchange — a uniquely important property for its use in neonatal respiratory support contexts.

Manufacturing Integrity

• API Solubility Maintenance: Ambroxol HCl concentration (7.5mg/ml) is maintained at full solubility through validated pH and co-solvent selection, preventing crystallisation or precipitation during filling and storage.
• Preservative Efficacy Testing: The drops preservative system is validated by Preservative Efficacy Testing (PET) per IP standard for multi-dose oral liquid preparations, confirming microbiological protection through the complete 24-month shelf life.

Saar Biotech provides Third-Party Manufacturing and Contract Manufacturing for Ambroxol Hydrochloride Oral Drops from our oral liquid manufacturing facility in Baddi, Himachal Pradesh.

• Facility: Oral liquid manufacturing block with controlled liquid compounding, precision small-volume filling systems, dropper fitment, cap sealing, labelling, and carton packing.
• Packaging: 15ml dropper bottle (HDPE or amber glass) — sticker label, printed cap, mono-carton, drip-off embossed carton; outer 360x15ml configurations.
• MOQ: 5,000 to 2,00,000+ dropper bottles per batch.
• Turnaround: New orders — 30–45 working days; Repeat orders — 20–25 working days.
• Documentation: Full COA, batch manufacturing record, and stability data on request.

Every commercial batch of Ambroxol Hydrochloride Oral Drops is released only after passing the following analytical protocol:

For B2B manufacturing enquiries, contract pricing, or complete product dossier for Ambroxol Hydrochloride 7.5mg/ml Oral Drops, please use the enquiry form below.