Posaconazole API Manufacturers & Suppliers in India

Posaconazole delayed-release tablets, oral suspension, and delayed-release oral suspension are used to prevent certain fungus (yeast) infections (eg, invasive Aspergillus or Candida infections) in patients who have a weakened immune system (eg, hematopoietic stem cell transplant or HSCT recipients, or patients with blood cancers). Posaconazole delayed-release tablets are also used to treat invasive aspergillosis.

Posaconazole oral suspension is also used to treat a fungus infection of the mouth or throat called oral thrush (candidiasis). Posaconazole oral suspension may be used as an initial treatment or after treatment with other antifungal medicines (eg, itraconazole or fluconazole) has failed.

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Product Description

Product Description

Generic Name:  Psaconazole API

Chemical Name :  4-[4-[4-[4-[[(3R,5R)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(2S,3S)-2-hydroxypentan-3-yl]-1,2,4-triazol-3-one·

CAS Number: 171228-49-2

Molecular weight: 700.8 g/mol

Molecular formula: C37H42F2N8O4

Category: Azole Antifungal

Therapeutic use:  Used to treat invasive infections caused by Candida species and Aspergillus species

Form:  Solid

Color: White to off-white

Size of Package: As per requirement

Solubility: Freely soluble in dichloromethane, soluble in THF, and sparingly soluble in methanol

Posaconazole API Specification

☐  Total impurities: Not more than 1.0%

☐ Single maximum unspecified impurity: Not more than 0.1%

Quality Standards and Manufacturing Excellence of Bio-Synth

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

Our facilities are equipped with cutting-edge technology and maintain strict adherence to GLP (Good Laboratory Practices), GDP (Good Documentation Practices), and cGMP (Current Good Manufacturing Practices). This results in consistent product quality, reinforcing Bio-Synth’s reputation for excellence.

Applications of Posaconazole API

Posaconazole is used to prevent serious fungal infections that can spread throughout the body in adults and children 2 years of age and older with a weakened ability to fight infection. Posaconazole delayed-release tablets are used to treat invasive aspergillosis (a serious fungal infection that begins in the lungs and spreads through the bloodstream to other organs) in adults and teenagers 13 years of age and older. Posaconazole oral suspension is also used to treat yeast infections of the mouth and throat including yeast infections in adults and teenagers 13 years of age and older that could not be treated successfully with other medications. .

Therapeutic Uses and Indications of Posaconazole

Used for prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised as a result of procedures such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD), or due to hematologic malignancies with prolonged neutropenia from chemotherapy. Also used for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole. Posaconazole is used as an alternative treatment for invasive aspergillosis, Fusarium infections, and zygomycosis in patients who are intolerant of, or whose disease is refractory to, other antifungals.

How Posaconazole API Works (Mechanism of Action)

As a triazole antifungal agent, posaconazole exerts its antifungal activity through blockage of the cytochrome P-450 dependent enzyme, sterol 14α-demethylase, in fungi by binding to the heme cofactor located on the enzyme. This leads to the inhibition of the synthesis of ergosterol, a key component of the fungal cell membrane, and accumulation of methylated sterol precursors. This results in inhibition of fungal cell growth and ultimately, cell death.

Why Choose Bio-Synth for Posaconazole API

Bio-Synth adheres to stringent quality protocols to ensure that each batch of Posaconazole API meets comprehensive global quality standards. Our robust quality control practices confirm the purity, potency, and safety of our products, ensuring reliable therapeutic results. We manufacture Posaconazole API in our 60kL WHO-GMP, ISO certified facility with a capacity of 300 kg/month.

Advantages and Key Features of Posaconazole API

☐ Posaconazole has significant efficacy against a variety of types of infectious yeast and filamentous fungus.

☐ Posaconazole is available in oral and intravenous formulations, is highly lipophilic, and gets distributed extensively in tissues.

☐ It is better tolerated than amphotericin B and has lower toxicity.

In a study, it was shown to be an effective treatment for patients with invasive fungal infections refractory to prolonged therapy with standard antifungal agents such as amphotericin B, fluconazole, and itraconazole.

Bio Synth: Posaconazole API Suppliers in India

Bio-synth is one of the leading API manufacturers in India that has included Posaconazole API in its product portfolio. Bio-synth manufactures all intermediates of Posaconazole API in-house, thereby offering the best quality, price, and lead time.

Posaconazole API Price in India

Bio Synth is a reputable supplier of pharmaceutical APIs and intermediates, including Posaconazole API, used to treat flu virus. Bio-Synth offers Posaconazole API at highly competitive prices tailored to your specific requirements. We ensure the best value while maintaining the highest quality standards. For detailed pricing and further inquiries, please reach out to us directly, and our team will be happy to assist you.

Frequently Asked Questions (FAQs)

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    Posaconazole API is the key ingredient in the azole antifungal drug used to treat invasive infections by Candida species and Aspergillus species. It plays a critical role in ensuring the drug’s effectiveness in managing severe fungal infections, particularly in immunocompromised patients.
    Posaconazole is used to prevent serious fungal infections that can spread throughout the body in adults and children 2 years of age and older with a weakened ability to fight infection. Posaconazole delayed-release tablets are used to treat invasive aspergillosis (a serious fungal infection that begins in the lungs and spreads through the bloodstream to other organs) in adults and teenagers 13 years of age and older. Posaconazole oral suspension is also used to treat yeast infections of the mouth and throat including yeast infections in adults and teenagers 13 years of age and older that could not be treated successfully with other medications.
    Bio-Synth offers premium-quality Posaconazole 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
    Bio-synth is one of the top manufacturers of APIs in India. We also manufacture Posaconazole API in India, offering top quality, competitive prices, and short lead times.

    The chemical composition of Posaconazole API is C37H42F2N8O4 which stands for 4-[4-[4-[4-[[(3R,5R)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(2S,3S)-2-hydroxypentan-3-yl]-1,2,4-triazol-3-one·

    Yes, Posaconazole API is available for purchase in India. Bio-synth is one of the leading manufacturers and suppliers of API products. Please reach out via the enquiry form with your requirement, and we will be happy to assist you.

    Bio-Synth has almost 8 decades of experience manufacturing high-quality APIs, with Posaconazole API as one of the key products in its product portfolio, making Bio-Synth one of the trusted manufacturers in India.

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

    Our facilities are equipped with cutting-edge technology and maintain strict adherence to GLP (Good Laboratory Practices), GDP (Good Documentation Practices), and cGMP (Current Good Manufacturing Practices). This results in consistent product quality, reinforcing Bio-Synth’s reputation for excellence in manufacturing APIs.

    To place an order for Posaconazole API, contact Bio-Synth through our customer service team or by filling out the contact form on our website. We provide comprehensive support to guide you through the order process and ensure timely delivery to meet your specific needs.