What Affects Bilastine API Price? BioSynth Leads

July 6, 2025

What Affects Bilastine API Price? BioSynth Leads

In a competitive pharmaceutical market, knowing the pricing factors of Bilastine API is essential. Important for procurement professionals, formulation scientists, and regulatory affairs teams.

Bilastine is a second-generation antihistamine. Doctors use it to treat allergic rhinitis and urticaria. Global demand for it is growing. This is because it does not cause drowsiness and has good safety data.

BioSynth is one of India’s top API manufacturers. With over 80 years of experience, we provide high-quality Bilastine API and its intermediates. Our facilities are WHO-GMP certified. We also have a strong global supply network.

In this article, we explore the main factors that affect the Bilastine API market. These factors include pricing, sourcing, and regulatory alignment.

We also explain why BioSynth is the best partner for ethical pharmaceutical manufacturing around the world.

What Is Bilastine API and Why Is Its Pricing Volatile?

Bilastine (CAS Number: 202189784) is a non-sedating H1 antihistamine. It has received several regulatory approvals, and many users widely use it across Europe, Asia, and Latin America. The global Bilastine API market has expanded in recent years, driven by:

Increased prevalence of seasonal allergies and allergic rhinitis
Demand for alternatives to sedating antihistamines
Formulation development by generic producers post patent expiry

Top Factors Influencing Bilastine API Pricing

Factor	Impact on Price	Description
Raw Material Costs	High	Bilastine synthesis involves high-purity intermediates that are cost-sensitive, especially amid global solvent shortages.
Manufacturing Complexity	Medium to High	Involves multiple steps with enantioselective synthesis requiring GMP-compliant process controls.
Regulatory Compliance Costs	Medium	Cost of maintaining documentation, validation, and audits for EDQM/USFDA/WHO-GMP conformity.
Supply Chain Logistics	Low to Medium	Shipping costs, container availability, and logistics affect landed price per KG.
Volume of Order	Variable	Higher volumes often lead to reduced per KG pricing due to economies of scale.

Leading Importing Countries

India: Dominates global supply due to vertical integration, cost efficiency, and numerous WHO-GMP-certified sites.
Bangladesh: For FEFO (First Expiry First Out) formulation compliance and large tender-based supply chains.
Spain: Domestic formulation and EU market.
Vietnam: Increasing demand amid rising allergy incidence reports.

Bilastine Supply Chain Snapshot: Key Origins and Buyers

Top Manufacturing Countries

India: Dominates global supply due to vertical integration, cost efficiency, and numerous WHO-GMP-certified sites.
Spain
Canada

Bilastine API Sourcing from India: Regulatory & Quality Considerations

India remains a top choice for contract manufacturing and API procurement, offering cost-effective high quality Bilastine that complies with most major pharmacopeias. Here’s what procurement and RA teams need to consider:

Regulatory Document Checklist for Indian API Sourcing

Certificate of Analysis (CoA)
DMF Type II (Open/Closed part)
GMP Certificate or WHO-GMP
CEP (if available)
Stability Data and Impurity Profile
Process Validation & Batch Consistency Reports

At BioSynth, we simplify this documentation with each shipment. This helps clients prepare for USFDA, EMA, or WHO inspections.

Why Choose BioSynth for Bilastine API Supply?

BioSynth has a history that goes back to 1943. It has built a strong reputation as a trusted pharmaceutical partner.

Few companies can match our strong vertical integration and steady GMP compliance in making Bilastine API.

Key Advantages That Set BioSynth Apart

✅ WHO-GMP Certified Facilities: Located in Hyderabad, India, BioSynth’s facilities adhere to stringent national and international regulatory norms.

✅ In-house Intermediate Synthesis: We control the entire value chain, producing all Bilastine intermediates internally, reducing supply chain risk and improving quality control.

✅ Scalable Capacity: We produce up to 2 MT of Bilastine API each month. We ensure full batch traceability and documentation.

✅ Regulatory Alignment: ISO 9001:2015 certified processes, GDP, GLP, and cGMP practices embedded throughout our Quality Management System.

✅ Custom Manufacturing Options: We provide client-specific impurity profiling and analytical method validation to meet unique regulatory filing requirements.

BioSynth’s Commitment to Quality and Innovation

Every product that leaves BioSynth goes through several quality control tests. These tests include HPLC, GCMS, Karl Fischer, IR spectroscopy, and polymorphic profiling.

This process ensures high purity levels that meet ICH Q7 guidelines.

API Manufacturing Flow: Bilastine Production at BioSynth

Raw Material Sourcing > Intermediate Synthesis In-house
Chiral Purification / Resolution
Active Stage Processing
Drying & Milling
In Process QC
Final Packing Under cGMP
Analytical Release

Each step is monitored via SCADA systems and PAT protocols, ensuring reproducibility and batch-to-batch consistency.

Emerging Trends in Global API Procurement

Understanding the evolution of the global API market enables smarter sourcing decisions. Here are some relevant market shifts:

1. Demand for Dual Sourcing

COVID-19 underscored the need for multiple reliable suppliers across geographies, a trend impacting pricing stability for Bilastine.

2. Increased Scrutiny on Supply Chain Traceability

EU and US regulators are focusing more on supply chain integrity, making GMP-certified API exporters essential partners.

3. Growth in Telehealth & OTC Allergy Medications

Bilastine is being used in over-the-counter markets in many Asian and European countries. This is increasing the demand for bulk Bilastine API orders that are suitable for high-volume packaging.

Therapeutic Segment vs BioSynth API Portfolio

Attribute	Specification
Assay (HPLC)	≥ 98.5%
Related Substances	≤ 0.2% Individual; ≤ 1.0% Total
Polymorphic Form	Consistent with the Reference Standard
Residual Solvents	Within ICH limits
Heavy Metals	≤ 10 ppm
Particle Size	As per customer requirement

BioSynth’s depth across APIs offers the advantage of consolidated sourcing, regulatory ease, and consistent documentation for complete dossier submissions.

Therapeutic Segment vs BioSynth API Portfolio

Therapeutic Area	Key APIs Manufactured by BioSynth
Antihistamine	Bilastine
Anti-TB	Bedaquiline, PAS Sodium
Cardiovascular	Carvedilol
Antipsychotic	Amisulpride
Antidiabetic	Empagliflozin, Dapagliflozin
Anti-emetic	Metoclopramide

BioSynth’s depth across APIs offers the advantage of consolidated sourcing, regulatory ease, and consistent documentation for complete dossier submissions.

Partner with BioSynth: Your Trusted Bulk Drug Supplier from India

As API procurement becomes more strategic and compliance-heavy, BioSynth offers unmatched value:

Cost-optimized pricing grounded in in-house synthesis of all intermediates
Regulatory-ready QA/QC support for DMF submissions and audits
A global export footprint across Europe, Asia, and Middle East

Contact BioSynth Today for custom documentation, pricing quotes, or technical dossiers for Bilastine or any other therapeutic API in our portfolio.

Final Thoughts

Understanding Bilastine API pricing factors is critical to remaining competitive in formulation development, and aligning with a trusted Indian API manufacturer like BioSynth ensures consistency, compliance, and long-term reliability.

With our commitment to regulatory excellence, in-house innovation, and unmatched technical services, BioSynth leads the way in ethical, high-quality API production helping clients across the globe bring better medicines to market, faster.

📞 Reach out to us now to start a business conversation or download the BioSynth API product catalog tailored to your regional needs.