What Is Bilastine Used For? Applications in Modern Allergy Treatment

July 9, 2025

What Is Bilastine Used For? Applications in Modern Allergy Treatment

Allergic disorders continue to affect millions globally, leading to a sustained demand for safe, effective, and long-acting antihistamines.

Among the newer generation H1-antihistamines, Bilastine has emerged as a prominent therapy due to its favorable pharmacokinetic profile, non-sedating properties, and high selectivity.

As international regulatory standards tighten and sourcing reliability becomes paramount, buying Bilastine API from GMP-certified API manufacturers in India is becoming the preferred route for pharmaceutical makers worldwide.

With over 80 years of heritage in pharmaceutical production, Bio-Synth stands at the forefront of allergy treatment APIs, including Bilastine, and specialty molecules across various therapeutic areas.

Here, we explore Bilastine’s clinical applications, the API manufacturing process, and how Bio-Synth’s robust systems position it as a trusted global API partner.

What is Bilastine? Pharmacological Overview

Bilastine is a second-generation, non-sedating antihistamine used in the treatment of:

Seasonal Allergic Rhinitis (SAR)
Chronic Urticaria
Other IgE-mediated Hypersensitivity Conditions

A selective peripheral H1-receptor antagonist, Bilastine, demonstrates:

High affinity for histamine receptors
Minimal blood-brain barrier penetration
No significant QT prolongation
Rapid onset of action with 24-hour dosing

These characteristics make Bilastine a first-line treatment in global allergy management protocols.

Clinical Applications of Bilastine in Allergy Treatment

1. Seasonal and Perennial Allergic Rhinitis

Bilastine effectively relieves symptoms like sneezing, nasal congestion, and watery eyes caused by allergens such as pollen, dust mites, or dander.

Its non-sedating profile ensures higher patient compliance, especially for long-term therapy.

2. Chronic Spontaneous Urticaria

For patients suffering from idiopathic urticaria, characterized by spontaneous hives and itching, Bilastine provides consistent symptomatic relief with minimal fatigue or drowsiness.

3. Pediatric and Geriatric Use

With multiple studies validating its safety across age groups, Bilastine is increasingly being formulated in pediatric-friendly forms.

In the elderly, the lack of anticholinergic side effects offers a safer alternative to first-generation antihistamines.

4. Adjunct in Dermatology and ENT Treatment

Bilastine is also used as off-label symptomatic therapy in cases involving eczema, allergic conjunctivitis, and post-nasal drip disorders.

> Explore Bio-Synth’s API catalog for reliable and regulatory-compliant sourcing of Bilastine API and other allergy treatment APIs.

API Manufacturing: How Bilastine is Produced

Producing high-purity Bilastine requires GMP-compliant infrastructure, robust quality systems, and analytical excellence. Here’s a simplified flow of the Bilastine API manufacturing process:

🔬 Bilastine API Manufacturing Flow

Steps	Description
1. Raw Material Procurement	Sourcing GMP-grade starting materials & reagents
2. Multi-Step Synthesis	Controlled steps to build Bilastine’s complex structure
3. Purification	Use of crystallization, chromatography for impurity removal
4. Drying and Micronization	Controlled particle sizing for uniformity
5. In-process Quality Testing	HPLC, GC, IR to ensure identity, purity, and stability
7. Final Release & Packing	Compliance with ICH Q7 & pharmacopoeial standards

Key Considerations

Impurity Profiling: Controlled to meet European Pharmacopoeia (EP), US Pharmacopoeia (USP), or Indian Pharmacopoeia (IP) limits
Polymorphic Form Stability: Ensures consistency in final formulation
Residual Solvent Control: Class I solvents are avoided; ICH Q3C compliance

Why Choose Bio-Synth for Bilastine API Manufacturing?

As a globally trusted API manufacturer from India, Bio-Synth combines tradition with innovation to deliver high-quality, batch-consistent allergy treatment ingredients.

✅ WHO-GMP Certified Facilities

Our two state-of-the-art production plants in Hyderabad are WHO-GMP and ISO 9001:2015 certified, producing APIs under regulated and auditable systems.

✅ 80+ Years of Pharma Heritage

Founded in 1943, Bio-Synth is one of India’s original pharmaceutical manufacturers, deeply familiar with international compliance and export standards.

✅ Therapeutic Expertise Across Segments

Therapeutic Segment	Key APIs
Antihistamines	Bilastine
Antituberculosis	Bedaquiline, PAS Sodium
Antidiabetics	Empagliflozin, Dapagliflozin
Antipsychotic	Amisulpride
Cardiology	Carvedilol

✅ Global Client Base

Bio-Synth exports APIs to Europe, Asia-Pacific, and Africa, serving formulation manufacturers, CMOs, and research firms.

✅ Seamless Regulatory Support

DMF preparation and submission
CEP development and support
Stability data for zone-specific markets
A certificate of analysis (CoA) with every shipment

Regulatory Considerations When Sourcing Bilastine API from India

Indian API manufacturers are under increasing scrutiny from global regulators. Bio-Synth mitigates risk for international buyers by delivering:

🛡️ Total Compliance, Total Trust

GMP adherence with documented SOPs for every manufacturing batch
Analytical method validation in line with ICH Q2 standards
Batch-to-batch reproducibility via validated equipment & instruments
Periodic internal & third-party audits
Stringent controls for genotoxic impurities in alignment with ICH M7

By maintaining strong traceability and documentation norms, Bio-Synth ensures its APIs are ready for regulatory submissions and smooth imports in over 50 global markets.

Trends in Global API Procurement: Bilastine and Beyond

As demand for India-manufactured APIs grows, multiple factors influence buying decisions:

1. Shift from China to India

With rising ESG concerns and geopolitical instability, many buyers are shifting API sourcing from China to India. Bio-Synth offers cost-efficiency without compromising on quality or compliance.

2. Demand for One-Stop API Solutions

Procurement teams look for manufacturers who can supply APIs across multiple therapeutic areas. Bio-Synth offers over 50+ APIs and advanced intermediates under one umbrella.

3. Need for Technical Collaboration

Buyers are no longer seeking mere suppliers; they demand technical documentation, custom synthesis capabilities, and pilot scalability. Bio-Synth’s dedicated R&D and QA teams offer that edge.

How Bio-Synth Ensures Consistent Bilastine API Quality

Maintaining uniformity in chemical and physicochemical properties is essential for formulation stability and regulatory clearance.

Bio-Synth ensures batch consistency through:

In-house validated methods for all critical quality attributes
Real-time stability testing under ICH zones II & IVb
Automated equipment minimizes manual error
Continuous process validation based on long-term performance
Dedicated quality teams across QA, QC, and Regulatory Affairs

Partner with a Proven Leader in Bilastine Allergy APIs

Today’s pharmaceutical companies require more than just API suppliers; they need partners who drive compliance, consistency, and global readiness.

Whether you operate in generic drug manufacturing, innovative R&D, or third-party formulation, Bio-Synth offers the strategic edge your procurement team is looking for.

Contact Bio-Synth today for technical documentation, quotations, or to schedule a virtual inspection of our Bilastine API facilities.

Frequently Asked Questions (FAQs)

Q: Is Bilastine Api Available In Multiple Grades At Bio-Synth?

A: Yes, Bio-Synth offers Bilastine in IP and IHS grades and can customize specifications based on client requirements.

Q: Does Bio-Synth Support Regulatory Filings For Bilastine Formulations?

A: Absolutely. Our team provides DMFs, stability data, and technical documentation required for dossier submissions.

Q: Can Bio-Synth Handle Volume Scaling For Large Batch Orders?

A: Yes. With scalable reactors and GMP-certified lines, we deliver production flexibility from kilograms to multi-ton scale.