Bilastine API Manufacturers in India

Bilastine API Manufacturers & Suppliers

Bilastine is an antihistamine that is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, itchy nose, nasal secretion, nasal congestion, and red, streaming eyes) and other forms of allergic rhinitis. It is available as an oral tablet or oral solution and is taken once daily. It starts to work within 20 minutes of taking it and has a faster action compared to first-generation antihistamines. Bilastine’s advantages include its non-sedative properties, fast absorption and efficacy, and mini drug interactions

Description

Name of the product: Bilastine Fumarate

Chemical Name : 2-[4-(2-{4-[1-(2-Ethoxyethyl)-1H-benzimidazol-2-yl]-1-piperidinyl}ethyl)phenyl]-2-methylpropanoic acid

CAS Number: 202189-78-4

Molecular weight: 525.49 g/mol

Molecular formula: C32H31BrN2O2

Category: BCS Class II

Therapeutic useAntihistamine

Usage: Pharmaceuticals

Form: Crystalline powder

Color: White

Size of package: As per requirement

Storage: Preserve in a well-closed container

Synonyms:
2-[4-(2-(4-(1-(2-ethoxyethyl)benzimidazole-2-yl)piperidine-1-yl)ethyl)phenyl]-2-methyl-propanoic acid
4-[2-[4-[1-(2-Ethoxyethyl)-1H-benzimidazol-2-yl]-1-piperidinyl]ethyl]-α,α-dimethylbenzeneacetic acid
F-96221-BM1

Solubility: Bilastine has low aqueous solubility. It is a white to off-white crystalline powder with low solubility in water

Permeability: It exhibits high permeability across biological membranes

Bilastine manufacturers and suppliers in India

As a trusted leader among Bilastine API manufacturers in India, Bio-Synth offers high-quality, non-sedating antihistamines for the pharmaceutical industry. Known for its fast absorption and minimal drug interactions, Bilastine is effective in treating allergy symptoms such as sneezing, itching, and runny nose. Our commitment to innovation and quality positions Bio-Synth as a reliable partner for Bilastine API suppliers in India, providing a comprehensive range of Bilastine-related products.

Bilastine API Specification:

The Bilastine API specification ensures that each batch of Bilastine meets global quality standards. As Bilastine API manufacturers in India, Bio-Synth adheres to strict guidelines to ensure product purity and properties.

Quality Standards and Manufacturing Excellence at Bio-Synth:

At Bio-Synth, we maintain a zero-compromise approach to quality, ensuring that each Bilastine API and associated products adhere to the highest standards. Our Quality Management System integrates:

 WHO-GMP (Good Manufacturing Practices) compliance

ISO 9000:2015 certification

Adherence to ICH guidelines and pharmacopeia standards 

These certifications demonstrate our commitment to manufacturing Bilastine API that meets national and international requirements. Our manufacturing excellence, combined with a vision for innovation, ensures that every milligram of Bilastine upholds the company’s legacy of quality and trust

 Our facility is equipped with advanced testing protocols and stringent Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and Current Good Manufacturing Practices (cGMP) to ensure product integrity and consistency.

Bilastine API Applications

 Bilastine fumarate, an antituberculosis drug, works by binding to the adenosine triphosphate (ATP) synthase enzyme in mycobacteria, which prevents the production of ATP.

 India is rolling out a BPal shortened treatment regime. BPal, the new treatment regime involves the use of three medicines, Bedaquiline, Pretomanid and Linezolid with an 89 percent success rate within six months. The standard care, on the other hand, takes 18 months with a 52 percent success rate.

 Bilastine fumarate is classified under the Biopharmaceutical Classification System (BCS) as a Class II compound. This classification is based on its properties

Why Choose Bio-Synth for Bilastine API

Bio-Synth operates with an unwavering commitment to quality. Our manufacturing processes integrate

 WHO-GMP (Good Manufacturing Practices) compliance
 ISO 9000:2015 certification
 Adherence to ICH guidelines and pharmacopeia standards

Bio-synth manufactures all intermediates of Bilastine in-house, thereby controlling and assuring the highest quality, timely delivery, and most competitive pricing. Bio-synth can supply 2MT of Bilastine per month, with the ability to customize as per customer requirements while providing reliable technical support

Therapeutic Uses and Indications:

Bilastine is a non-sedative antihistamine used to treat allergic rhinitis and chronic urticaria. It effectively relieves symptoms such as sneezing, nasal congestion, runny nose, itchy eyes, hives, and itching. With a rapid onset of action and minimal side effects, Bilastine is suitable for both acute and long-term management of allergic conditions.

How Bilastine API Works (Mechanism of Action)

Bilastine is an antihistamine that works by blocking the H1 receptor on mast cells, preventing the release of histamine and other inflammatory mediators.


Bilastine is rapidly absorbed and selective for H1 receptors. Hence, it is not associated with the adverse effects of first-generation H1 antihistamines (e.g. sedation and antimuscarinic effects). The non-sedative effect of bilastine results from its limited penetration across the blood-brain barrier, thus reducing any negative impact on the central nervous system which, for other antihistamines, can include the synergistic effects of alcohol and benzodiazepines.

How Ethopabate API Works (Mechanism of Action)

Bilastine API works by selectively blocking histamine H1 receptors, which are responsible for allergic reactions. By inhibiting histamine binding, it prevents symptoms like itching, swelling, and inflammation. Its high specificity ensures effective relief from allergies without causing sedation, making it ideal for treating conditions such as allergic rhinitis and urticaria.

Introduction to Bio-synth's Capabilities

Bio-synth specializes in niche APIs and advanced intermediates for the pharmaceutical industry. As leading bilastine manufacturers in India along with numerous other APIs and intermediates, we have production capacity of 2 MT/month. We adhere to WHO-GMP and ISO 9000 and are in the process of complying with EU-CEP and USFDA. We have a strong R & D and production team that can cater to specific customer requirements. 

Advantages and Key Features of Bilastine

 ☐ Non-Sedative Properties: Bilastine is a second-generation antihistamine, ensuring effective relief from allergy symptoms without causing drowsiness, making it suitable for daytime use.

   Fast Absorption and Efficacy: Bilastine is rapidly absorbed, providing quick relief from sneezing, itching, and runny nose, ensuring effective symptom management for patients.

   Minimal Drug Interactions: Known for its low potential for drug interactions, Bilastine can be safely used alongside most other medications, enhancing patient compliance.

Bilastine Intermediates Suppliers and Manufacturers in India


Bio-Synth is the leading supplier of Bilastine intermediates, Methyl 2-(4-(2-chloroethyl)phenyl)-2-methylpropanoate and Methyl 2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo [d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoate and API in India. As a leading bilastine intermediates manufacturer in India, Bio-Synth supplies high-purity intermediates essential for the production of Bilastine. Our advanced manufacturing processes ensure that each intermediate is of the highest quality, enabling the production of safe and effective Bilastine APIs. With a robust supply chain, competitive pricing and bulk supply capabilities, Bio-Synth is one of the most reliable bilastine intermediates suppliers in India.

Bilastine API Price in India

Bio-Synth offers competitive pricing for Bilastine API in India without compromising on product quality. We strive to make Bilastine accessible for pharmaceutical manufacturers and distributors, ensuring affordability while maintaining the highest standards of production. For reliable Bilastine API suppliers in India, Bio-Synth remains the top choice for pharmaceutical companies. Our expertise in both API and intermediates production ensures that we meet the growing demand for high-quality, non-sedating antihistamines.

Related Intermediates

Frequently asked questions

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    Bilastine is primarily used to treat symptoms of seasonal allergic rhinitis and chronic urticaria (hives), such as sneezing, itching, and runny nose. It provides non-drowsy relief, making it ideal for daytime use

    Bilastine works by blocking the H1 histamine receptors in the body, reducing allergic reactions without causing drowsiness. This mechanism makes it a preferred option for managing allergies while maintaining normal daily activities.

    Bio-Synth offers high-quality Bilastine API that meets global standards like WHO-GMP and ISO 9000:2015 certification. Our rigorous quality control ensures consistent and reliable Bilastine supply, making us a top choice for Bilastine API suppliers in India.

    To place an order for Bilastine API, contact Bio-Synth through the provided customer service details or fill out the contact form for sample requests and further information. We are one of the leading Bilastine API manufacturers in India and ensure timely delivery to meet your needs.

    The CAS number of Bilastine API is 202189-78-4, which serves as its unique identifier in the Chemical Abstracts Service database. This globally recognized number ensures accurate identification of the substance in scientific research, manufacturing, and regulatory processes. It is particularly important for pharmaceutical applications to maintain consistency and quality standards when sourcing or working with Bilastine API.

    Bio-Synth is one of the leading manufacturers of Bilastine API and intermediates in India with the capacity to supply 2MT/month. Bio-Synth offers top-quality products at competitive prices.

    Bio-Synth operates with an unwavering commitment to quality. Our manufacturing processes integrate:

    WHO-GMP (Good Manufacturing Practices) compliance

    ISO 9000:2015 certification

    Adherence to ICH guidelines and pharmacopeia standards

    Bilastine is an antihistamine that works by blocking the H1 receptor on mast cells, preventing the release of histamine and other inflammatory mediators

    Bio-Synth offers premium-quality Bilastine API at competitive prices, tailored to meet your specific requirements. By handling all production stages internally, we maintain strict control over quality while optimizing pricing. For accurate pricing and to discuss your specific needs, we encourage you to reach out with your inquiry. Our team is dedicated to providing timely responses and ensuring your complete satisfaction.

    Yes, Bio-Synth can supply Bilastine API in bulk quantities. Please reach out to us via the enquiry form with your requirements and we will get back to you at the earliest.