Levocloperastine Oral Suspension
Levocloperastine Fendizoate IP eq. to Levocloperastine 20mg/5ml Oral Suspension · Cough & Cold, Respiratory
WHO-GMP
DCGI Approved
Baddi, HP
Active Pharma Composition
SUSPENSION PRESENTATION:
Each 5 ml contains:
Levocloperastine Fendizoate IP eq. to Levocloperastine
20 mg
Flavoured Suspension Base
q.s.
Product Data Sheet
Segments & Ranges
Suspensions / Oral Liquids / Syrups
Dosage Form
Oral Suspension
Pharma Class
Cough & Cold / Respiratory
Pack Sizes
60 ml / 100 ml
Storage Condition
Store below 30°C in a cool, dry place. Protect from direct sunlight. Do not freeze. Shake well before every use.
Stability / Shelf Life
24 Months
Manufacturing Location
Baddi, Himachal Pradesh
Compliance
DCGI Approved / Schedule M
Pack Options
60ml & 100ml — sticker label, metallic label, drip-off embossed carton, measuring cap, printed cap, with/without carton
Batch Size
5,000 to 2,00,000+ Units
Schedule M Compliant
Private Label Ready
Pan-India Dispatch
WHO-GMP
ISO 9001:2015
GLP Certified
DCGI Approved
Schedule M
Product Profile
Levocloperastine Fendizoate Suspension is a peripherally acting, non-opioid antitussive formulation indicated for effective cough relief without CNS depression. As a premier WHO-GMP certified pharmaceutical manufacturer in Baddi, Saar Biotech manufactures this suspension with validated API quality control and precise taste-masking.
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
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
Description & Therapeutic Class
Levocloperastine Suspension belongs to the Suspensions category within the Cough & Cold and Respiratory therapeutic segments. It provides peripherally mediated cough suppression.
Saar Biotech manufactures this suspension from our manufacturing facility in Baddi.
Pan-India Supply & Contract Manufacturing
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
The Saar Biotech Advantage
At Saar Biotech, we manufacture Levocloperastine Suspension using a controlled oral suspension manufacturing process that ensures dose uniformity and palatability.
- Suspension Uniformity: Levocloperastine is uniformly suspended for consistent dosing.
- Taste Masking: Palatable suspension 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 cough treatment courses.
Pan-India Supply & Contract Manufacturing
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
Key Indications & Clinical Use
This suspension is manufactured and supplied by Saar Biotech for the following established clinical indications:
- Acute Cough: Symptomatic relief of acute non-productive cough
- Chronic Cough: Management of chronic cough conditions
- Post-viral Cough: Relief from persistent cough following viral infections
- Irritative Cough: Cough associated with airway irritation
Pan-India Supply & Contract Manufacturing
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
Mechanism of Action & Manufacturing Integrity
Levocloperastine modulates sensory neuropeptide release in the airways, reducing cough reflex sensitivity through peripheral mechanisms without CNS depression.
Manufacturing Integrity
- API Stability: Levocloperastine remains stable in suspension when formulated correctly.
- Suspension Uniformity: The active is uniformly suspended for consistent dosing.
Pan-India Supply & Contract Manufacturing
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
B2B & Contract Manufacturing Details
Saar Biotech provides Third-Party Manufacturing for Levocloperastine Suspension from our oral suspension manufacturing facility in Baddi, Himachal Pradesh.
- Facility: Oral suspension 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
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
Storage & Handling Guidelines
- Warehouse Conditions: Store below 30°C in a cool, dry environment. Do not freeze.
- Shake Well Before Every Dose: Critical for uniform API distribution.
- Measuring Cup Use: A calibrated measuring cup ensures accurate dosing.
- Light Protection: Dark amber bottles and outer cartons protect from light-induced degradation.
Pan-India Supply & Contract Manufacturing
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
Quality Control & Compliance
Every commercial batch is quarantined until it passes a comprehensive analytical release protocol:
- HPLC Assay: Quantification of Levocloperastine content.
- Suspension Uniformity: Sediment behaviour and re-dispersibility testing.
- pH & Viscosity Testing: Suspension stability monitoring.
- Microbial Limit Testing (MLT): IP-compliant microbiological testing.
- Certificate of Analysis (COA): Issued with every B2B batch.
Pan-India Supply & Contract Manufacturing
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
Safety Profile & Precautions
- Non-Opioid: No CNS depression, respiratory depression, or dependency risk.
- Minimal Side Effects: Generally well-tolerated.
- Contraindications: Known hypersensitivity to any component.
- Precautions: Use with caution in patients with severe hepatic impairment; in productive cough where expectoration is clinically indicated.
For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Levocloperastine Suspension, please use the B2B enquiry form below.
Pan-India Supply & Contract Manufacturing
Batch Lead Time
30-45 Days (Domestic)
B2B Services
Contract & Third-Party
Compliance
DCGI & Schedule M Standards
Medical Intelligence
Clinical Q&A for Levocloperastine Oral Suspension
Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.
What are the clinical indications for Levocloperastine Suspension?
Levocloperastine Suspension is indicated for the symptomatic relief of acute and chronic cough, particularly non-productive cough. It is a peripherally acting antitussive that does not cross the blood-brain barrier significantly, reducing the risk of CNS side effects compared to centrally acting antitussives. It is a Schedule H prescription product.
How does Levocloperastine differ from Dextromethorphan and Codeine?
Levocloperastine is a peripherally acting antitussive with a unique mechanism involving modulation of sensory neuropeptide release in the airways. Unlike Dextromethorphan (centrally acting) and Codeine (opioid), Levocloperastine does not cause CNS depression, respiratory depression, or dependency at therapeutic doses. This makes it particularly suitable for patients who require cough suppression without impaired alertness.
What is the standard dosing protocol?
The standard adult dose is 5 to 10 ml (20–40mg) taken two to three times daily as directed by a physician. For pediatric patients, dosing should be weight-based under physician supervision. The suspension should be shaken well before each use.
What are the key precautions for Levocloperastine?
Levocloperastine is generally well-tolerated with minimal side effects. Caution is advised in patients with severe hepatic impairment. It should be used with caution in patients with productive cough where expectoration is clinically indicated. Use during pregnancy and lactation should be under physician supervision.
What are the common side effects?
Levocloperastine is well-tolerated. Occasional side effects may include mild gastrointestinal discomfort or headache. Unlike opioid antitussives, it does not cause sedation, constipation, or respiratory depression.
Manufacturing Support
B2B Manufacturing Guide for Levocloperastine Oral Suspension
Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.
What pack sizes and packaging options are available for Levocloperastine Suspension?
Saar Biotech manufactures Levocloperastine Suspension in 60 ml and 100 ml bottle formats. Packaging options include: sticker label, metallic label, drip-off brand embossed carton, measuring cap, printed cap, company-logo printed PP cap, with-carton or without-carton supply.
What is the MOQ for this suspension?
Standard MOQ ranges from 5,000 to 10,000 units per SKU, depending on bottle size, label type, and carton format.
What analytical tests are performed on every batch?
Every batch undergoes HPLC Assay confirming Levocloperastine content, suspension uniformity testing, pH and viscosity testing, and Microbial Limit Testing (MLT). A Certificate of Analysis (COA) is issued with every consignment.
Does Saar Biotech support brand name registration for Levocloperastine?
Yes. Our regulatory team offers DCGI brand name search and registration support for antitussive products. We ensure Schedule H classification documentation and product artwork meet all DCGI labelling requirements, facilitating faster market entry for new brands entering the non-opioid antitussive segment.
What is the turnaround time for a new Levocloperastine Suspension order?
Initial third-party manufacturing batches are dispatched within 30 to 45 working days of packaging artwork approval. Brands with repeat suspension orders benefit from our optimised scheduling in Baddi, with fulfilment typically within 20 to 25 working days for commercial repeat batches.
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