Levosalbutamol + Ambroxol + Guaifenesin Drops

Belonging to the Oral Drops category within the Respiratory, Cough & Cold, and Pediatric Care therapeutic segments, this formulation is the concentrated pediatric drops analog of the widely prescribed Levosalbutamol + Ambroxol + Guaiphenesin adult syrup — designed specifically for the infant and young toddler age group where 5ml spoon dosing is impractical.

The drops formulation addresses the three core pathophysiological elements of pediatric productive cough with bronchospasm:

• Levosalbutamol Sulphate 0.25mg/ml — the R-enantiomer of salbutamol; selective beta-2 bronchodilation with reduced cardiac side-effect burden compared to racemic salbutamol — the critical safety advantage in infant prescribing.
• Ambroxol Hydrochloride 7.5mg/ml — mucolytic; breaks down viscid mucus, stimulates surfactant production, and enhances mucociliary clearance.
• Guaiphenesin 12.5mg/ml — expectorant; increases respiratory secretion volume and fluidity, facilitating productive expectoration of thinned mucus.

At these concentrated drops-format strengths, a typical 0.5–1ml infant dose delivers clinically meaningful amounts of all three actives in a minimum liquid volume — the defining advantage of the drops format over suspension for very young patients. Saar Biotech manufactures this formulation from our facility in Baddi, with strict three-active dose uniformity validation.

At Saar Biotech, we manufacture Levosalbutamol + Ambroxol + Guaifenesin Drops using a precision-concentrated liquid formulation process that addresses the specific technical demands of a high-active-concentration, small-volume infant dosing product.

• Concentrated Three-Active Uniformity: At 7.5mg Ambroxol and 12.5mg Guaifenesin per 1ml — versus 15mg/5ml and 50mg/5ml in the equivalent syrup — the drops format requires a substantially more concentrated and precisely dispersed API system. Our compounding sequence and in-process sampling protocol ensure uniform active distribution throughout the full 15ml bottle volume, so the first and last drops a parent administers are clinically equivalent.
• Dropper Calibration to Product Viscosity: The drops-format dropper must deliver accurate 0.5ml or 1ml volumes against the specific viscosity of this concentrated syrupy base. Our dropper systems are validated specifically against the finished product’s viscosity — not against water or a generic standard — ensuring the per-squeeze volume is accurate for this formulation.
• Infant-Appropriate Taste Masking: The 7.5mg/ml Ambroxol concentration in drops produces a significantly more intense bitter impact per volume than the 15mg/5ml syrup. Our flavour system is specifically calibrated for this higher active density, using a mild mixed-fruit or neutral-sweet profile that effectively masks the concentrated Ambroxol bitterness without overwhelming the small dose volume.
• Premium 15ml Dropper Pack Execution: Drip-off Brand Name Embossed cartons, glass or amber PET bottle options, and quality printed caps give pediatric respiratory brands a professionally credible, premium appearance appropriate for the pediatric prescriber and parent-purchaser market.

Manufactured and supplied by Saar Biotech for the following pediatric respiratory indications:

• Acute Bronchiolitis with Productive Cough: RSV and viral bronchiolitis in infants often presents with mucus plugging and reactive airway constriction. The triple combination addresses both components simultaneously — Levosalbutamol opens the airway, Ambroxol and Guaifenesin facilitate mucus clearance.
• Asthmatic Bronchitis: Recurrent wheezing with productive cough in young children — a common presentation where both bronchodilation and mucolytic therapy are prescribed.
• Acute Bronchitis: Upper and lower respiratory infection-associated productive cough with bronchospasm components in children under 3 years.
• Post-Viral Productive Cough: Persistent cough with mucus retention following viral URTI resolution, where mucociliary dysfunction perpetuates cough even after viral clearance.

Three-Component Pediatric Respiratory Mechanism

Levosalbutamol is the R(-)-enantiomer of racemic salbutamol. It selectively binds beta-2 adrenergic receptors on bronchial smooth muscle with minimal affinity for cardiac beta-1 receptors, activating adenylate cyclase to increase intracellular cAMP and cause smooth muscle relaxation and bronchodilation. Clinical studies confirm equivalent bronchodilation to racemic salbutamol at half the milligram dose, with significantly fewer cardiovascular and CNS side effects — the pharmacological basis for its preference in infant prescribing where safety margins are narrower.

Ambroxol Hydrochloride cleaves mucopolysaccharide disulfide bonds in bronchial secretions, reducing viscosity and enabling cilia to transport mucus more effectively. It also stimulates type II alveolar cells to produce and secrete surfactant, reducing surface tension in small airways and preventing atelectasis. This dual mucolytic and surfactant-stimulating action makes it particularly valuable in neonatal and infant respiratory conditions where surfactant deficiency compounds mucus plugging.

Guaiphenesin acts via gastric vagal reflex stimulation to increase the volume of bronchial secretions, effectively diluting thick, concentrated mucus into a more fluid form. This dilution reduces mucus adhesiveness and makes it far more amenable to Ambroxol’s mucolytic action and ciliary transport — the synergistic basis for using both molecules together.

Manufacturing Integrity

• Levosalbutamol Oxidative Stability: The R-enantiomer of salbutamol is susceptible to racemization and oxidative degradation at non-optimal pH. Our formulation buffer maintains the drops vehicle in the validated pH window that prevents these degradation pathways throughout the 24-month shelf life.
• Multi-Active Microbial Control: Ambroxol at high concentration (7.5mg/ml) can support microbial growth if the preservative system is not adequate for this concentrated matrix. Our preservative efficacy testing validates complete antimicrobial protection across the 15ml bottle’s expected in-use period.

• Concentrated Format = Minimal Volume Burden: The primary pharmacokinetic advantage of the drops format is that a full therapeutic dose is delivered in 0.5–1ml instead of 5ml. For an infant with an already-compromised airway and feeding difficulties, minimizing the liquid volume administered per dose is a direct clinical benefit that drives prescriber preference for drops over suspension in the youngest patients.
• Drops Segment Premium Positioning: Pediatric respiratory drops command a per-unit price premium over equivalent syrup formulations. The calibrated dropper, specialized 15ml amber bottle format, and premium carton presentation justify a higher brand MRP — providing better margins for pharmaceutical marketing companies relative to standard suspension products.
• Year-Round Demand with Seasonal Peaks: Pediatric bronchiolitis and asthmatic bronchitis have pronounced seasonal incidence spikes in winter and monsoon — creating predictable high-prescription demand periods that brands can plan for through advance production bookings with Saar Biotech.
• 360×15ml Shipper Configuration: Bulk shipping in 360-unit shippers optimizes logistics cost for distributors handling high-volume seasonal pediatric respiratory orders, reducing per-unit transport cost and simplifying warehouse management.

Saar Biotech offers Contract Manufacturing (CMO) and Third-Party Manufacturing for Levosalbutamol + Ambroxol + Guaifenesin Oral Drops from our oral liquid manufacturing facility in Baddi, Himachal Pradesh.

• Facility: Dedicated oral drops filling line with amber PET and glass bottle filling, calibrated dropper assembly, carton insertion, and shrink-wrapping capability.
• Capacity: From 5,000-unit brand-entry batches to 2,00,000+ unit commercial runs; 360×15ml shipper configurations available.
• Quality Lab: In-house GLP-certified lab with HPLC for three-active assay at concentrated drops strengths, uniformity-of-dose testing, pH, viscosity, MLT, dropper calibration verification on every batch.
• Turnaround: New orders — 30 to 45 working days. Repeat orders — 20 to 25 working days.
• Packaging: 15ml amber PET or glass bottle with calibrated dropper; Drip-off Brand Embossed carton, sticker label, HUC carton, normal label, printed cap, silver cap; with/without outer carton; 360×15ml shipper.
• MOQ: 5,000–10,000 units per SKU.

1. Temperature and Light Protection: Store below 30°C in the original amber PET or glass bottle away from direct sunlight. Levosalbutamol is sensitive to UV degradation; the amber packaging and outer carton must remain intact during distribution and pharmacy storage.
2. Tight Closure Between Doses: The dropper bottle must be capped tightly after every use. In a repeated-use 15ml bottle administered multiple times daily, closure discipline is critical to prevent evaporation of the flavoring system and microbial ingress.
3. No Freezing: Sub-zero temperatures alter the drops base viscosity profile and may cause active precipitation. Cold-chain logistics are not required.
4. Dropper Hygiene: The dropper tip must not contact the infant’s mouth, lips, or tongue during administration — contact contamination from the infant’s oral microbiome can compromise microbiological safety of the remaining product in the bottle.

Every commercial batch of Levosalbutamol + Ambroxol + Guaifenesin Drops is quarantined until it passes a comprehensive release protocol:

• Three-Active HPLC Assay: Simultaneous quantification of Levosalbutamol Sulphate (0.25mg/ml), Ambroxol HCl (7.5mg/ml), and Guaiphenesin (12.5mg/ml) via validated HPLC against IP specifications — the critical release test for this concentrated infant-dosing product.
• Uniformity of Dose: Multiple samples from different fill positions within the 15ml bottle are assayed to confirm homogeneous active distribution — ensuring the first and last dose from the bottle are clinically equivalent.
• pH and Viscosity Testing: pH confirmed for Levosalbutamol stability; viscosity verified against the dropper calibration specification.
• Microbial Limit Testing (MLT): IP-compliant microbiological testing for infant-use oral drops product.
• Dropper Calibration Verification: Per-squeeze volume confirmed within ±5% tolerance against the finished product’s viscosity.
• Fill Volume and Closure Integrity: Automated fill-volume checks and cap torque testing on every 15ml bottle.
• Certificate of Analysis (COA): Issued with every B2B batch for partner documentation and regulatory records.

Generally well tolerated in the pediatric population at prescribed doses. Levosalbutamol-related side effects — fine tremors, mild tachycardia, restlessness — are significantly less frequent than with equivalent racemic salbutamol doses. Headache, mild gastrointestinal discomfort, and mild nausea from Guaifenesin are occasionally reported.

Levosalbutamol is contraindicated with non-selective beta-blockers. Use with extreme caution in infants with congenital cardiac conditions, hyperthyroidism, or known hypersensitivity to any component. All dosing for infants must be weight-based and physician-directed — self-medication is not appropriate for this age group.

For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Levosalbutamol + Ambroxol + Guaifenesin Oral Drops, please use the enquiry form below.