Bilastine Oral Solution
Bilastine IP 2.5mg/1ml Oral Solution · Anti-Histamines, Cough & Cold, Pediatric Care
WHO-GMP
DCGI Approved
Baddi, HP
Active Pharma Composition
ORAL SOLUTION PRESENTATION:
Each 1 ml contains:
Bilastine IP
2.5 mg
Flavoured Syrupy Base
q.s.
Product Data Sheet
Segments & Ranges
Oral Liquids / Syrups
Dosage Form
Oral Solution
Pharma Class
Anti-Histamines / Cough & Cold / Pediatric Care
Pack Sizes
60 ml
Storage Condition
Store below 30°C in a cool, dry place. Protect from direct sunlight. Keep tightly closed.
Stability / Shelf Life
24 Months
Manufacturing Location
Baddi, Himachal Pradesh
Compliance
DCGI Approved / Schedule M
Flavor Options
Mixed Fruit and Strawberry — preferred for pediatric solutions
Pack Options
60ml — 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
Bilastine 2.5mg/1ml Oral Solution is a non-sedating antihistamine indicated for allergic rhinitis and urticaria. As a premier WHO-GMP certified pharmaceutical manufacturer in Baddi, Saar Biotech manufactures this oral solution with precise API assay control.
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
Bilastine Oral Solution belongs to the Anti-Histamines and Pediatric Care therapeutic segments.
Saar Biotech manufactures this oral solution 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 Bilastine Oral Solution using a controlled liquid formulation process that ensures dose uniformity and palatability.
- API Uniformity: Bilastine is uniformly distributed for consistent dosing.
- Taste Masking: Mixed fruit and strawberry flavours ensure patient acceptance.
- pH and Stability Management: The active remains chemically stable for 24 months.
- 60ml Pack Coverage: Suitable for allergy management.
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 oral solution is manufactured and supplied by Saar Biotech for the following established clinical indications:
- Seasonal Allergic Rhinitis: Relief from pollen allergy symptoms
- Perennial Allergic Rhinitis: Year-round allergy relief
- Chronic Idiopathic Urticaria: Reduction of itching and hives
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
Bilastine competitively blocks H1 histamine receptors, preventing histamine-induced allergic symptoms.
Manufacturing Integrity
- pH Stability: The solution base is pH-buffered to maintain active stability.
- Taste Masking: Effective taste-masking ensures patient compliance.
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 Bilastine Oral Solution 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 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. Protect from direct sunlight.
- Light Protection: Amber bottles and outer cartons protect from photo-degradation.
- Measuring Cup Use: A calibrated measuring cap ensures accurate dosing.
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 Bilastine 2.5mg per 1ml.
- 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.
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
- Low Sedation: Minimal sedation compared to first-generation antihistamines.
- Food Interaction: Take on an empty stomach for optimal absorption.
- Contraindications: Known hypersensitivity to any component.
For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Bilastine Oral Solution, 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 Bilastine Oral Solution
Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.
What are the clinical indications for Bilastine Oral Solution?
Bilastine Oral Solution is indicated for the symptomatic relief of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria in adults and children. Bilastine is a second-generation antihistamine with a rapid onset of action and non-sedating profile.
How does Bilastine work as an antihistamine?
Bilastine is a selective H1 receptor antagonist that competitively blocks histamine from binding to H1 receptors. It does not cross the blood-brain barrier significantly, resulting in minimal sedation. It has a rapid onset of action (within 30–60 minutes) and a long duration of action.
What is the standard dosing protocol?
For adults and children over 12 years, the typical dose is 1 ml (2.5mg) twice daily or 2 ml (5mg) once daily. For children aged 6 to 11 years, the dose is 0.5 ml (1.25mg) twice daily. Dosing should always follow the physician’s prescription.
What are the key precautions for Bilastine?
Bilastine should be taken on an empty stomach (1 hour before or 2 hours after meals) to optimise absorption. Caution is advised in patients with renal impairment and those taking other medications that may affect its absorption.
What are the common side effects?
Common side effects may include headache, fatigue, drowsiness (less than first-generation antihistamines), and dry mouth. These are typically mild and transient.
Manufacturing Support
B2B Manufacturing Guide for Bilastine Oral Solution
Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.
What pack sizes and packaging options are available for Bilastine Oral Solution?
Saar Biotech manufactures Bilastine 2.5mg/1ml Oral Solution in 60 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 Bilastine Oral Solution?
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 manufacturing batch?
Every batch undergoes HPLC Assay confirming Bilastine content, pH and viscosity testing, and Microbial Limit Testing (MLT). A Certificate of Analysis (COA) is issued.
What is the turnaround time for a new order?
Initial third-party production typically requires 30 to 45 working days following packaging confirmation. Repeat orders are fulfilled in 20–25 working days.
Do you offer private labelling and packaging design?
Yes, our in-house design team provides end-to-end support for private label packaging, including mono-cartons, labels, and promotional materials compliant with regulatory guidelines.
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