Levodropropizine + CPM Syrup
Levodropropizine and Chlorpheniramine Maleate Syrup · Cough & Cold, Respiratory
SYRUP PRESENTATION:
Product Profile
Levodropropizine + Chlorpheniramine Maleate Syrup is a pharmacologically differentiated cough formulation — combining a peripherally acting, non-sedating antitussive with a first-generation H1 antihistamine to deliver effective dry cough relief without the central nervous system depression associated with conventional antitussive agents. As a WHO-GMP certified pharmaceutical manufacturer in Baddi, Saar Biotech manufactures Levodropropizine 30mg + CPM 2mg Syrup for pharmaceutical companies seeking third-party manufacturing, contract manufacturing, and private-label respiratory brand supply.
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
Levodropropizine + CPM Syrup belongs to the Syrups category within the Cough & Cold and Respiratory therapeutic segments. What distinguishes this formulation commercially is the nature of its antitussive component — Levodropropizine is a peripherally acting antitussive, representing a clinically distinct category from the centrally acting Dextromethorphan that dominates most cough syrup formulations.
The two-molecule formula addresses the dual pathway of cough and allergic upper respiratory symptoms:
- Levodropropizine 30mg per 5ml — acts on peripheral sensory C-fiber nerve endings in the bronchial mucosa, reducing their hypersensitivity and suppressing the cough reflex without engaging central opioid or sigma receptors.
- Chlorpheniramine Maleate 2mg per 5ml — first-generation H1 antihistamine controlling histamine-mediated rhinorrhea, sneezing, and allergy-triggered cough with mild sedation.
For pharmaceutical marketing companies, Levodropropizine represents an increasingly important prescriber choice as awareness of the CNS-safety profile grows among physicians managing cough in working adults, elderly patients, and those on multiple medications. Saar Biotech manufactures it from our facility in Baddi in 100ml and 120ml commercial formats.
Pan-India Supply & Contract Manufacturing
The Saar Biotech Advantage
At Saar Biotech, we manufacture Levodropropizine + CPM Syrup using a controlled oral liquid manufacturing process that ensures dual-API assay accuracy, consistent palatability, and packaging versatility across 100ml and 120ml commercial formats.
- Precise Two-API HPLC Assay: Both Levodropropizine and Chlorpheniramine Maleate are confirmed simultaneously on every batch at their declared strengths. Levodropropizine is a relatively newer antitussive API with stringent quality requirements — our validated HPLC methodology ensures exact label claim compliance.
- CPM Bitterness Management: The CPM component carries a characteristic bitter note. Our flavour system — calibrated specifically for this two-active combination — ensures complete bitterness masking in mixed fruit and strawberry directions while maintaining the clean syrup mouthfeel expected of adult cough formulations.
- Peripheral Antitussive Positioning: The product’s core B2B value lies in its clinical differentiation from DMR-based syrups. Our regulatory team supports brand launch positioning that accurately communicates the peripheral mechanism advantage to prescribers through compliant label and promotional material.
- Premium 120ml Metallic Pack Execution: The 120ml format in metallic sticker label with dom bottle creates a premium visual identity suited to the growing adult cough care segment, where presentation influences prescriber recommendation.
Pan-India Supply & Contract Manufacturing
Key Indications & Clinical Usage
Levodropropizine + CPM Syrup is manufactured and supplied by Saar Biotech for these clinically established indications:
- Dry, Non-Productive Cough: The primary indication. Levodropropizine reduces the hypersensitivity of bronchial sensory receptors that drive dry cough in viral URTIs, post-viral irritative cough, and cold presentations — without CNS depression.
- Allergic Rhinitis-Associated Cough: CPM blocks H1-mediated histamine activity responsible for the rhinorrhea and postnasal drip that triggers dry cough in allergic patients.
- Cough in Patients Requiring Alertness: Working adults, drivers, and elderly patients on multiple sedating medications benefit from Levodropropizine’s peripheral-only mechanism that preserves daytime alertness.
- Adult Cold & Allergy Cough Management: A clean two-active formula for physicians who prefer a simple, pharmacologically justified prescription without a nasal decongestant component when congestion is not the primary complaint.
Schedule H — Requires valid medical prescription.
Pan-India Supply & Contract Manufacturing
Mechanism of Action & Manufacturing Integrity
Dual-Component Clinical Mechanism
Levodropropizine is the levo-enantiomer of dropropizine. Unlike Dextromethorphan (which acts centrally on sigma-1 and NMDA receptors in the brainstem) or codeine (which acts on mu-opioid receptors), Levodropropizine acts peripherally on bronchopulmonary sensory C-fibers — the unmyelinated afferent nerve endings in the bronchial wall that detect irritants and transmit cough-triggering signals. By reducing the sensitivity of these peripheral receptors, Levodropropizine elevates the cough threshold without any meaningful central nervous system engagement. This peripheral-only mechanism explains why it produces none of the sedation, respiratory depression, or dependency associated with centrally acting antitussives at therapeutic doses.
Chlorpheniramine Maleate competitively antagonizes histamine at the H1 receptor, preventing histamine from binding to and activating vascular endothelium and respiratory mucosal sensory nerves. This blocks histamine-induced rhinorrhea, sneezing, and the allergic sensory stimulation that triggers the cough reflex in atopic patients.
Manufacturing Integrity
- Levodropropizine Chemical Stability: Levodropropizine is a chiral molecule whose enantiomeric purity must be maintained throughout manufacturing and storage. Our formulation team selects pH, preservative, and storage conditions that protect the levo-enantiomer from racemization — ensuring the product retains its pharmacologically specific peripheral activity.
- Two-API Vehicle Compatibility: Both Levodropropizine and CPM must remain chemically stable in the same aqueous syrup vehicle across the 24-month shelf life. Our validated excipient and preservative system ensures neither molecule degrades through interactions with the vehicle or each other.
Pan-India Supply & Contract Manufacturing
Pharmacokinetics & B2B Commercial Value
- Peripheral Action = No Sedation Liability: Levodropropizine’s bioavailability after oral dosing is moderate, with peak plasma concentrations achieved within 1–2 hours. Critically, even at Cmax, CNS penetration is minimal compared to central antitussives — explaining the preserved alertness profile that is the product’s primary clinical selling point.
- CPM Sedation Management: The mild sedation of CPM 2mg per 5ml is present but less pronounced than higher-dose CPM formulations. Evening dosing or physician-directed caution counseling for drivers and machine operators adequately manages this known effect without compromising therapeutic utility.
- Differentiating Prescriber Narrative: For pharmaceutical marketing company field teams, the message is clear and medically accurate: “Levodropropizine gives your patient the same dry cough relief as a central antitussive — but without the CNS side effects that limit daytime function.” This one-line prescriber message differentiates the brand from dozens of DMR-based cough syrups with identical therapeutic class positioning.
- 100ml and 120ml Pack Coverage: The 100ml format covers a standard 5–7 day adult cough treatment course at 10ml three times daily. The 120ml extends coverage and offers better per-ml value for patients with longer cough episodes or chronic respiratory presentations.
Pan-India Supply & Contract Manufacturing
B2B & Contract Manufacturing Details
Saar Biotech provides Third-Party Manufacturing and Contract Manufacturing for Levodropropizine + CPM Syrup from our oral liquid manufacturing facility in Baddi, Himachal Pradesh.
- Facility: Oral liquid filling lines for 100ml and 120ml presentations; automated filling, capping, labeling, and carton packing.
- Capacity: Scalable from brand-entry batches to 2,00,000+ unit commercial runs; 100×100ml and 120×100ml shipper configurations for distributor supply.
- Quality Lab: In-house GLP-certified lab with validated HPLC assay for Levodropropizine and CPM, pH, specific gravity, MLT, and fill volume checks.
- Turnaround: New orders — 30 to 45 working days. Repeat orders — 20 to 25 working days.
- Packaging: 100ml and 120ml amber PET bottles; sticker label, metallic sticker label, dom bottle, silver leafing, drip-off embossed carton, tricolour measuring cap, printed cap, company-logo PP cap, sleeve pack, with/without carton.
- MOQ: 5,000–10,000 units per SKU.
Pan-India Supply & Contract Manufacturing
Storage & Handling Guidelines
- Temperature Control: Store below 30°C in a cool, dry place. Levodropropizine and CPM are both susceptible to accelerated degradation at sustained high ambient temperatures — particularly relevant for summer distribution across Indian retail channels.
- Light Protection: Amber PET bottles with tightly capped closures protect both actives from photodegradation. Outer cartons should be maintained until dispensing at pharmacy level.
- Measuring Cap Use: A calibrated measuring cap ensures accurate 5ml or 10ml dosing, which matters for CPM dose management — slight overdosing at the 2mg per 5ml level can produce disproportionate sedation in sensitive patients.
- Cap Closure After Use: The bottle should be tightly closed after each dose to prevent flavour evaporation and microbial ingress during the multi-day treatment course.
Pan-India Supply & Contract Manufacturing
Quality Control & Compliance
Every commercial batch of Levodropropizine + CPM Syrup is quarantined until it passes a comprehensive release protocol in our GLP-certified QC laboratories in Baddi:
- Two-API HPLC Assay: Simultaneous quantification of Levodropropizine 30mg and Chlorpheniramine Maleate 2mg per 5ml against specifications — the primary release test for this formulation.
- pH & Specific Gravity: Monitored to confirm syrup stability and correct viscosity for accurate dose measurement.
- Appearance & Flavour: Batch-to-batch sensory consistency verified for the mixed fruit or strawberry profile.
- Microbial Limit Testing (MLT): IP oral liquid compliance testing before every batch release.
- Fill Volume & Pack Inspection: Automated fill-volume checks, cap integrity, measuring-cap inclusion, and label placement verified before dispatch.
- Certificate of Analysis (COA): Issued with every B2B consignment.
Pan-India Supply & Contract Manufacturing
Safety Profile & Precautions
Levodropropizine is generally well tolerated. Most adverse effects relate to the CPM component — drowsiness, dry mouth, dizziness. Patients should avoid alcohol and driving if sedation occurs. Levodropropizine itself rarely causes adverse effects at therapeutic doses; occasional mild gastrointestinal discomfort has been reported.
Contraindicated with MAO inhibitors. Use with caution in hepatic impairment. Not for use in productive cough where expectoration is clinically beneficial.
For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Levodropropizine + CPM Syrup, please use the B2B enquiry form below.
Pan-India Supply & Contract Manufacturing
Clinical Q&A for Levodropropizine + CPM Syrup
Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.
What is Levodropropizine + CPM Syrup prescribed for?
How does Levodropropizine differ from centrally acting antitussives like Dextromethorphan or Codeine?
What is the standard dosing protocol for Levodropropizine + CPM Syrup?
What are the key contraindications and precautions?
Is Levodropropizine + CPM Syrup appropriate for children?
Does Levodropropizine affect mucus clearance or respiratory muscle function?
B2B Manufacturing Guide for Levodropropizine + CPM Syrup
Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.
