Bilastine API Certifications Trusted Source

Bilastine API Certifications Trusted Source

Because of the growing need for safe and effective antihistamines, Bilastine has become popular in healthcare markets worldwide.

For pharmaceutical manufacturers, contract developers, and distributors wanting reliable quality in Bilastine API certifications, BioSynth is a well-known provider. 

With over 80 years of experience in pharmaceutical manufacturing, BioSynth has a strong legacy.

BioSynth is one of India’s top GMP-certified API manufacturers. We make sure that every batch of Bilastine API follows international and domestic regulations. 

 

Why Bilastine API Matters in Modern Therapeutics

Bilastine (CAS No: 202189784) is a nonsedating antihistamine predominantly prescribed for the treatment of allergic rhinitis and chronic urticaria. It offers rapid symptom control without central nervous system depression, making it a superior option for patients requiring sustained allergy management with improved tolerability.

 

Key Characteristics of Bilastine API

Parameter	Specification
Chemical Name	Bilastine
CAS Number	202189784
Molecular Formula	C28H37N3O3
Molecular Weight	463.62 g/mol
Therapeutic Category	Antihistamine (H1 receptor)
Pharmacopeial Grade	IP
Regulatory Documentation	DMF under process, ISO 9001:2015 certified
Shelf Life & Stability	3 years

 

Bio-Synth: Eight Decades of Unmatched Pharmaceutical Manufacturing

BioSynth operates in India and maintains certified production sites in Hyderabad. A leading global API manufacturer exists.

The company offers a range of products. These include anti-TB drugs like Bedaquiline and PAS Sodium. They also produce antipsychotic, cardiology, antidiabetic, and antihistamine APIs, such as Bilastine.

 

Our Unique Capabilities:

1.  80+ Years of industry heritage (established 1943)
2.  State-of-the-art GMP-compliant manufacturing facilities
3.  Comprehensive quality systems with ISO 9001:2015
4.  Proven expertise in scale-up and cGMP batch production

We are dedicated to high-quality and scalable production. This ensures our Bilastine API meets strict regulations. It also provides a reliable supply, which is essential in today’s changing global pharmaceutical market.

 

Regulatory Pathway for Bilastine API Certifications

Compliance is critical in API sourcing, especially for regulated markets. BioSynth’s Bilastine API comes with the full suite of regulatory and technical documentation.

 

Available Regulatory Support Includes:

•  Drug Master File (DMF): In process for regulated market submissions

1.  GMP Certificate: Full traceability from raw materials to final API
2.  Certificate of Analysis (CoA) for each batch
3.  Impurity profiling and ICH stability data
4.  TSE/BSE compliance declarations

Our regulatory affairs team works closely with clients around the world. We help them with their product filings. 

 

Pharmaceutical Ingredient Suppliers: What Sets BioSynth Apart?

The marketplace in India has many bulk drug manufacturers. However, few provide the mix of heritage, precise manufacturing, and regulatory skill that BioSynth offers.

 

Top Reasons Why Global Clients Choose BioSynth:

1. End-to-End Control From chemical intermediates to finished API production
2. Specialization in challenging APIs such as Bedaquiline, PAS Sodium and antipsychotics
3. Smart Quality Control Systems with in-process checks, cGMP SOPs, and batch monitoring
4. Flexible contract manufacturing and custom synthesis options
5. Proven ability to deliver high volume orders 

We are a top API supplier for TB control programs in Russia and Latvia. We build our systems for scale, compliance, and flexibility.

 

API Manufacturing Process Flow: Ensuring Quality in Every Step

Bilastine API manufacturing involves multiple synthesis, purification, and quality analysis stages. BioSynth employs a controlled and validated process flow to ensure consistency, safety, and batch uniformity.

 

Bilastine API Process Overview

1. Sourcing of advanced raw materials and intermediates
2. Synthesis Reaction: Controlled under defined reaction parameters
3. Crude Purification: Removal of by-products and unreacted intermediates
4. Crystallization: To ensure product purity and a defined polymorphic form
5. Drying and Milling: Particle sizing for formulation compatibility
6. QC Analysis: Assay, HPLC purity, residual solvents, heavy metals, microbial limits
7. Final Release with CoA & Regulatory Documentation

Every production batch is released only after a rigorous QC analysis validated against pharmacopeial and client-specific standards.

 

Global API Sourcing Trends: The Rise of India as a Pharma Powerhouse

With ongoing disruptions in global API supply chains, India has emerged as the preferred hub for pharmaceutical ingredient suppliers. The country has strong infrastructure and skilled workers. It also has good policies, such as the PLI scheme for bulk drug parks. These factors make it a great partner for long-term sourcing.

 

Key Trends in API Procurement

1.  Shift toward India based GMP suppliers for cost effective, high-quality sourcing
2.  Emphasis on regulatory transparency and data integrity (ALCOA+ standards)
3.  Heightened demand for auditable, traceable manufacturing
4.  Strategic partnerships for sustainability and carbon footprint reduction

 

Therapeutic Segments & Sample 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

 

This diversified pipeline ensures our clients can find integrated sourcing options for their therapeutic portfolios.

Sourcing Bilastine API from India: What to Look For

When buying APIs online or through partnerships, procurement professionals should consider more than just the product price.

Evaluation Checklist:

1.  Are the certificate & DMF versions updated and market accepted?
2.  Are GMP audits and CoAs transparently shared?
3.  Is there batch consistency over production cycles?
4.  Does the supplier offer regulatory assistance for CTD/DMF filings?
5.  Are there scalable manufacturing provisions for commercial volumes?
6.  Is there a transparent supply chain & logistics system in place?

With BioSynth, the answer is “yes” to all the above. We share our performance metrics and quality data openly with qualified partners. This strengthens our reputation as a trusted GMP certified API exporter.

Connect with India’s Trusted Bulk Drug Manufacturer

As your organization explores Bilastine API certifications and global sourcing options for antihistamines, BioSynth stands ready with unmatched experience, regulatory support, and scalable manufacturing.

We invite pharmaceutical manufacturers, procurement houses, CMOs, and R&D divisions to partner with a company that combines legacy with future ready innovation.

📩 Contact BioSynth today for custom quotes or technical documentation on Bilastine API and other pharmaceutical ingredients. [info@bio-synth.com]