Bilastine CAS Number 202189-78-4 | GMP API Manufacturer India
Bilastine CAS Number 202189-78-4 | GMP API Manufacturer India, Hyderabad
Last Updated: January 2026
Summary:
The CAS number of Bilastine is 202189-78-4.
Bilastine is a second-generation, non-sedating antihistamine used in the treatment of allergic rhinitis and chronic urticaria. It is widely sourced by pharmaceutical formulators from WHO-GMP certified manufacturers such as Bio-Synth, based in Hyderabad, India.
Introduction: Why Bilastine CAS Number Matters in API Procurement
The global demand for high-quality Active Pharmaceutical Ingredients (APIs) continues to rise, particularly in:
- Allergy treatment
- Cardiovascular therapies
- Anti-diabetic formulations
- Tuberculosis treatment
Among these, Bilastine API stands out as a modern, non-sedating antihistamine.
When sourcing APIs, procurement teams frequently reference:
Bilastine CAS Number: 202189-78-4
Understanding the CAS number ensures:
- Correct molecular identification
- Regulatory accuracy
- Avoidance of substitution errors
- Documentation alignment for DMF and CTD filings
Understanding Bilastine and Its Therapeutic Relevance
Bilastine is a second-generation H1 antihistamine known for:
- High receptor selectivity
- Minimal CNS penetration
- 24-hour symptomatic relief
- Non-sedative profile
Key Clinical Advantages
- Non-cardiotoxic
- Once-daily dosing (long half-life)
- Excreted largely unchanged
- Suitable for paediatric and geriatric patients
Common Bilastine Formulations
- 20 mg tablets
- Oral solutions
- Combination therapies for seasonal allergic rhinitis
Why Choose Indian API Manufacturers for Bilastine?
India remains the global leader in cost-effective Bilastine API exports due to:
- WHO-GMP compliant facilities
- USFDA and ISO-certified plants
- Strong regulatory track records
- Mature supply chain infrastructure
Hyderabad, especially the Balanagar industrial zone, is a major API hub.
Bio-Synth exemplifies these strengths, exporting APIs to 30+ countries with a strong presence in allergy, TB, cardiovascular, and anti-diabetic segments.
Bilastine CAS Number 202189-78-4: Technical Specifications
Procurement teams require precise product validation before sourcing.
Below is a typical specification profile:
| 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 | Below 25°C, dry conditions |
| Purity (HPLC) | ≥ 99.5% |
| Compliance | WHO-GMP, ISO 9001:2015 |
Explore Bio-Synth’s API catalog for regulatory-compliant sourcing.
Regulatory & Documentation Support for Global Clients
Entering regulated markets requires comprehensive documentation.
Bio-Synth provides:
- Certificate of Analysis (CoA)
- GMP certificates
- Method of Analysis (MoA)
- MSDS documentation
- Stability data (ICH compliant)
- Impurity profiling & residual solvent reports
- Open & closed-part DMFs
This ensures smooth regulatory submissions in:
- EU
- US
- Asia-Pacific
- MENA
Bio-Synth: Trusted Antihistamine API Manufacturer
With over 80 years of manufacturing excellence, Bio-Synth offers:
Facility Highlights
- WHO-GMP certified plants (Hyderabad)
- Reactors from 100L to 5000L+
- Real-time HPLC, GC, IR testing
- ISO 9001:2015 compliance
- SAP-based inventory tracking
- Dedicated Regulatory Affairs team
Therapeutic Segments Supported
| Therapeutic Area | Key APIs |
|---|---|
| Anti-Allergy | Bilastine |
| Tuberculosis | PAS Sodium, Bedaquiline |
| Cardiology | Carvedilol |
| Antipsychotic | Amisulpride |
| Anti-Diabetic | Empagliflozin, Dapagliflozin |
Bio-Synth also provides custom synthesis & scale-up services for innovators and generic manufacturers.
Global API Sourcing Trends
Current industry trends include:
- Diversified API sourcing strategies
- Digital procurement via verified CoAs
- Preference for GMP-certified exporters
- Increased focus on green chemistry
- Strategic late-stage intermediate partnerships
When sourcing Bilastine API from India, buyers should:
- Verify traceability
- Review stability studies
- Assess long-term production scale
- Evaluate analytical reproducibility
Bio-Synth supports project-based sampling and audit readiness documentation.
How Bio-Synth Ensures Batch Consistency
Quality is ensured through:
- Process Analytical Technology (PAT)
- 100% in-process verification
- 5-year retention samples
- Bi-annual revalidation of methods
- Continuous OOS & deviation review
This guarantees batch-to-batch reproducibility required for global submissions.
Frequently Asked Questions
1. What is the CAS number of Bilastine?
The CAS number of Bilastine is 202189-78-4.
2. Can Bio-Synth provide Bilastine samples for formulation trials?
Yes. GMP-grade samples are available with full CoA and MSDS documentation upon request.
3. What is the typical lead time for bulk Bilastine API orders?
The average dispatch time is 2–3 weeks, depending on order volume and documentation requirements.
4. Is micronized Bilastine available?
Yes. Both micronized and non-micronized grades are available with customizable particle size distribution (PSD).
Final Thoughts
As allergy prevalence rises globally, Bilastine continues to be a preferred non-sedating antihistamine API.
By sourcing from WHO-GMP aligned manufacturers like Bio-Synth, procurement teams ensure:
- Regulatory confidence
- Stable supply
- High purity
- Global compliance
Contact Bio-Synth today for custom quotes, regulatory documents, or technical dossiers for Bilastine API.
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