What is the CAS number of Bilastine?

What is the CAS number of Bilastine?

The global demand for high-quality Active Pharmaceutical Ingredients (APIs) continues to surge, particularly in therapeutic segments like allergy treatment, cardiovascular disease, anti-diabetics, and tuberculosis. 

Among these, Bilastine, an innovative non-sedating antihistamine, stands out for its efficacy in treating allergic rhinitis and chronic urticaria. 

With Bilastine CAS Number 202189-78-4 emerging frequently in pharmaceutical sourcing directories, procurement professionals and formulators need to understand the lifecycle, quality status, and sourcing options for this critical API.

 

As a WHO-GMP certified pharmaceutical manufacturer with over 80 years of excellence, Bio-Synth provides not just robust manufacturing capabilities, but also regulatory visibility and client-focused reliability in bulk drug production. 

This guide offers a deep dive into Bilastine API sourcing, best practices, quality systems, and how Bio-Synth supports innovation and consistency in global formulations.

Understanding Bilastine and Its Therapeutic Relevance

Bilastine is a second-generation H1-antihistamine, offering high receptor selectivity, minimal central nervous system penetration, and 24-hour symptomatic relief without causing drowsiness. 

Its high oral bioavailability and favorable pharmacokinetics make it a preferred molecule among formulators of anti-allergic medications.

Key Benefits of Bilastine:

• Non-sedative, non-cardiotoxic profile
• Long half-life allowing once-daily dosing
• No significant metabolism is excreted unchanged
• Favoured in pediatric, geriatric, and renal-impaired populations

Common Formulations Containing Bilastine API:

• Bilastine 20 mg tablets
• Bilastine oral solutions
• Combination drugs for seasonal allergic rhinitis

 

Why Choose Indian API Manufacturers for Bilastine?

India remains the world’s top supplier of affordable, high-quality APIs, owing to its strong industrial base, skilled talent pool, and strict adherence to global regulatory standards.

Advantages of Choosing Indian API Exporters:

• Cost-effective bulk drug manufacturing
• WHO-GMP, USFDA, and ISO-certified facilities
• Established supply chain networks for fast global delivery
• Proven track record in regulatory documentation and site audits

 

With its cutting-edge R&D investment and regulatory focus, Bio-Synth, based in Hyderabad, exemplifies these strengths. 

The company supplies APIs and intermediates to formulators in 30+ countries, with a particular focus on Bilastine, PAS Sodium, Bedaquiline, and APIs across TB, antipsychotic and cardiovascular segments.

 

Bilastine CAS Number 202189-78-4: Technical Specifications

 

Procurement teams require precise product knowledge while sourcing any API. Below is a typical technical profile for Bilastine API supplied by Bio-Synth:

 

Parameter	Specification
CAS Number	202189-78-4
Molecular Formula	C28H37ClN4O3
Molecular Weight	500.08 g/mol
Appearance	White to off-white crystalline powder
Solubility	Soluble in methanol and DMSO
Storage Conditions	Store below 25°C in dry environment
Purity (HPLC)	≥ 99.5%
Compliance	WHO-GMP, ISO 9001:2015

 

Explore Bio-Synth’s API catalog for reliable and regulatory-compliant sourcing

Regulatory and Documentation Support for Global Clients

Regulatory documentation is a cornerstone for entering regulated markets such as the EU, US, and the Asia-Pacific. Bio-Synth provides full support with:

1. Certificate of Analysis (CoA)
2. GMP Certificate and Manufacturing License
3. Method of Analysis (MoA)
4. MSDS (Material Safety Data Sheet)
5. Stability Data (on request)
6. Impurity profile and residual solvent compliance
7. Open and closed part Drug Master Files (DMFs)

We ensure one-stop technical collaboration, speeding your time-to-market while simplifying regulatory submissions.

Bio-Synth: Your Trusted Partner for Allergy-Antihistamine APIs

 

With over eight decades of pharmaceutical manufacturing knowledge, Bio-Synth is uniquely positioned among API manufacturers in India to provide buyers with dependability, innovation, and long-term supply commitments.

Our Facility Highlights:

• WHO-GMP-certified plants in Hyderabad
• Scalable reactors: From 100L to 5000L and beyond
• Real-time HPLC, GC, and IR spectrometry testing
• Strict compliance with ISO 9001:2015, Environmental Health & Safety standards
• SAP-driven inventory and supply chain monitoring
• Dedicated regulatory affairs and documentation team

Therapeutic Segment vs Product Focus

Therapeutic Area	Bio-Synth Key API Offerings
Anti-Allergy	Bilastine
Tuberculosis	PAS Sodium, Bedaquiline
Cardiology	Carvedilol
Antipsychotic	Amisulpride
Anti-Diabetic	Empagliflozin, Dapagliflozin

 

Bio-Synth also supports custom synthesis services for innovator companies and generic manufacturers seeking robust intermediates and scale-up partnerships.

Global API Sourcing: Trends and Considerations

Key Trends in Global API Procurement:

1. Diversification of API sources to reduce single-country dependency
2. Digital procurement using verified analytical data and COAs
3. Preference for GMP-certified API exporters with full traceability
4. Growing demand for green chemistry and EHS-compliant manufacturers
5. Strategic partnerships for late-stage intermediates and cGMP scale-ups

Considerations When Sourcing Bilastine from India:

• Ensure the supplier offers traceability from raw material to API
• Evaluate production scale for long-term demand assurance
• Check for analytical data reproducibility across batches
• Ask for stability studies under ICH guidelines

 

At Bio-Synth, our team supports clients with project-specific sampling, pre-formulation evaluations, and audit-readiness documentation.

How Bio-Synth Ensures Batch Consistency and Quality

Our Quality Management System (QMS) is designed for batch-to-batch reproducibility and continuous improvement. Here’s how we guarantee consistency:

1. Process analytical technology (PAT) integration
2. 100% in-process verification for key parameters
3. Retention samples from each lot for 5 years
4. Revalidation of cleaning methods and analytical techniques every 6 months
5. Regular review of Out-of-Specification (OOS) and deviation reports

Final Thoughts

As demand for allergy treatments rises globally due to urban pollution and immunological disorders, Bilastine continues to play a central role as a safe and effective antihistamine API. 

By sourcing from GMP-aligned, quality-first manufacturers like Bio-Synth, pharmaceutical procurement teams can ensure long-term compliance, formulation stability, and regulatory success.

 

Ready to build a stable supply chain partner in India?

 

Contact Bio-Synth today for custom quotes, regulatory documents, or technical dossiers. Let us help you bring safe, effective therapies to global markets.

 

Frequently Asked Questions

• Can Bio-Synth provide Bilastine samples for formulation trials?

Yes. Technical-grade and GMP-grade samples with full CoA and MSDS are available on request.

• What is the typical lead time for large quantity orders?

Our average dispatch time is 2–3 weeks, depending on the client location and documentation needs.

• Do you offer Bilastine in custom particle sizes?

Yes. Micronized and non-micronized material available; particle size distribution (PSD) is customized for solid dose or suspension formulations.