Top Export Destinations for Bilastine Made in India
Top Export Destinations for Bilastine Made in India
In the dynamic landscape of global pharmaceutical trade, India plays a pivotal role as a leading exporter of Active Pharmaceutical Ingredients (APIs).
One of the APIs witnessing rising international demand is Bilastine, a second-generation antihistamine used in treating allergic conditions.
Its low sedation profile and high selectivity for peripheral histamine H1-receptors make it a preferred therapeutic agent worldwide.
Among the trusted API manufacturers in India, Bio-Synth stands out for its commitment to quality, regulatory compliance, and efficient global distribution.
As Bilastine export destinations from India continue to expand across regulated and semi-regulated markets, Bio-Synth is shaping the future of B2B pharmaceutical supply with best-in-class manufacturing and scalable production capabilities.
Why Bilastine? A Growing Global Demand
- Bilastine is extensively used for:
- Allergic rhinitis (seasonal and perennial)
- Chronic idiopathic urticaria
Its advantages over first-generation antihistamines (like diphenhydramine or hydroxyzine) include:
- No central nervous system (CNS) sedation
- Minimal hepatic metabolism (no CYP450 interaction)
- Once-daily dosing due to long half-life
These pharmacokinetic attributes have amplified market demand from:
- Europe (Germany, Italy, Spain)
- Southeast Asia (Vietnam, Thailand, Malaysia)
- Latin America (Brazil, Mexico)
- Middle East and Africa
- South Asia (Bangladesh)
India’s Role in Bilastine API Supply: Trusted Global Partner
India’s robust pharmaceutical infrastructure and regulatory adherence make it a preferred origin for regulated market API sourcing.
Key Advantages of Indian API Manufacturers:
- Cost-effective production without compromising quality
- Established GMP compliance
- Strong intellectual property understanding for permissible exports
- Scalable production to meet global volume requirements
With over 80 years of heritage, Bio-Synth has positioned itself as a trusted partner for clients seeking to buy Bilastine and other APIs reliably and efficiently.
Bio-Synth: A Proven Exporter of Bilastine and Essential APIs
✅ WHO-GMP Certified Manufacturing Facilities in Hyderabad
- Bio-Synth’s manufacturing plants are compliant with:
- WHO-GMP standards
- ISO 9001:2015 Quality Management Systems
- Environmental and occupational safety standards
Each batch of Bilastine API is produced under strict GMP protocols, ensuring:
- Consistency in particle size and purity
- Impurity profiling according to ICH Q3A/B
- Suitable for regulated and semi-regulated markets
Bilastine Manufacturing Flow: Bio-Synth’s Process Excellence
Precision in API synthesis is integral to dosage form safety and efficacy. At Bio-Synth, we follow a multi-stage synthesis protocol for Bilastine, incorporating robust in-process controls (IPCs) and stringent final batch testing.
API Manufacturing Flow: Bilastine
- Starting Material Selection
Use of pharma-grade, validated raw materials
- Multi-Step Organic Synthesis
Including amidation, cyclization, and esterification
- Crystallization and Particle Sizing
Achieving uniform morphology and flow characteristics
- Purification and Drying
Vacuum drying under controlled temperatures
- Final QC/QA Testing
HPLC Assay, IR Spectroscopy, Residual Solvents by GC
- Stability Studies and CoA Release
As per ICH Q1A guidelines
Every lot is backed by comprehensive documentation, including:
- Batch Manufacturing Record (BMR)
- Certificate of Analysis (CoA)
- Material Safety Data Sheet (MSDS)
- Regulatory support files (if required)
Bio-Synth’s Edge in Global API Sourcing
Why Do Procurement Officers Prefer Bio-Synth?
- Regulatory Excellence
- Files available for DMF/CEP support on request
- Stringent compliance with WHO-GMP and ICH guidelines
- Scalability
- Flexible batch sizes: 5 kg to commercial 1000+ kg
- Short lead time for custom quantities
- Product Versatility
- APIs for critical therapeutic segments:
- TB Drugs: PAS Sodium, Bedaquiline
- Cardiology: Carvedilol
- Antipsychotics: Amisulpride
- Anti-diabetics: Empagliflozin, Dapagliflozin
- Global Distribution Network
- Active client base across 45+ countries
- Reliable shipment tracking and customs documentation
Regulatory Considerations While Sourcing Bilastine API from India
When importing Bilastine API, buyers must evaluate:
- COAs backed by validated analytical methods
- Regulatory filings (e.g., EU DMFs, US Type II DMF, WHO PQ documents)
- GMP audit reports and facility inspection history
- Vendor quality agreements aligned with ICH Q7
- Adherence to pharmacopoeial specifications (Ph. Eur., USP, or IP, depending on destination)
At Bio-Synth, we offer full technical documentation and regulatory support throughout your sourcing journey.
Procurement Trend: Bilastine API Pricing & Availability
The global shift towards non-drowsy antihistamines and the decreasing patent restrictions on Bilastine have led to:
- More generic manufacturers are entering the market
- Strengthened price negotiation opportunities
- Growing demand from OTC and prescription markets
However, quality consistency and regulatory standing remain differentiators.
Factors Affecting API Pricing:
- Raw material supply chain (e.g., Benzimidazole derivatives)
- Crude intermediate volatility
- Labor and utility cost trends in India
- Regulatory burden and export logistics
Bio-Synth’s in-house backward integration and raw material vetting help ensure cost predictability and quality.
Therapeutic Segment vs. Bio-Synth Product Portfolio
|
Therapeutic Area |
Key APIs from Bio-Synth |
|
Antihistamines |
Bilastine |
|
Anti-TB |
PAS Sodium, Bedaquiline |
| Cardiology |
Carvedilol |
| Anti-diabetic |
Empagliflozin, Dapagliflozin |
| Antipsychotics |
Amisulpride |
With cross-segment manufacturing capabilities, Bio-Synth simplifies multi-product procurement for formulation companies.
How Bio-Synth Ensures Quality Consistency Batch After Batch
Maintaining uniformity is not just a regulatory need, it is a clinical imperative.
At Bio-Synth, consistency is achieved through:
- Process Validation as per ICH Q8
- Analytical method validation under ICH Q2(R1)
- Periodic equipment calibration and preventive maintenance
- Ongoing stability testing per market-specific climate zones
- Supplier qualification for raw materials and solvents
- Electronic data log of every batch from RM to final pack
Audited by international clients, Bio-Synth adheres to Good Documentation Practices (GDP) and ISO-compliant QMS.
Partner with Bio-Synth: Your Trusted API Source from India
Pharmaceutical importers, R&D teams, and formulation developers globally rely on Bio-Synth’s proven track record, transparent processes, and technical integrity.
If you’re sourcing Bilastine API or any other therapeutic compound, choose a partner with:
- 80+ years of experience
- Multi-therapeutic API range
- WHO-GMP-certified facilities
- Global reach with local responsiveness
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