Nirmatrelvir API Manufacturers & Suppliers in India

Nirmatrelvir (PF-07321332) is an orally bioavailable 3C-like protease (3CLPRO) inhibitor that is the subject of clinical trial NCT04756531.4 3CLPRO is responsible for cleaving polyproteins 1a and 1ab of SARS-CoV-2.1 Without the activity of the SARS-CoV-2 3CLPRO, nonstructural proteins (including proteases) cannot be released to perform their functions, inhibiting viral replication.

In December 2021, the FDA granted an emergency use authorization to Paxlovid, a co-packaged product containing both nirmatrelvir and ritonavir, for the treatment of certain patients with mild-to-moderate COVID-19. It was fully approved by the FDA on May 25, 2023. Paxlovid was approved for use in Canada in January 2022 for the treatment of adult patients with mild-moderate COVID-19 and later granted conditional marketing authorization by the European Commission on January 27, 2022.

 

Check Price

Product Description

Product Description

Generic Name: Nirmatrelvir API

Chemical Name :  (1R,2S,5S)-N-[(1S)-1-cyano-2-[(3S)-2-oxopyrrolidin-3-yl]ethyl]-3-[(2S)-3,3-dimethyl-2-[(2,2,2-trifluoroacetyl)amino]butanoyl]-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide

CAS Number: 2628280-40-8

Molecular weight: 499.5 g/mol

Molecular formula: C23H32F3N5O4

Category: Antiviral

Therapeutic use:  Used to treat mild to moderate COVID-19

Form:  Powder

Color: White to off-white

Size of Package: As per requirement

Synonyms: (1R,2S,5S)-N-((S)-1-Cyano-2-((S)-2-oxopyrrolidin-3-yl)ethyl)-3-((S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido)butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide; 3-Azabicyclo[3.1.0]hexane-2-carboxamide, N-[(1S)-1-cyano-2-[(3S)-2-oxo-3-pyrrolidinyl]ethyl]-3-[(2S)-3,3-dimethyl-1-oxo-2-[(2,2,2-trifluoroacetyl)amino]butyl]-6,6-dimethyl-, (1R,2S,5S);

Solubility: Sparingly soluble in ethanol, soluble in acetonitrile, and slightly soluble in isopropyl alcohol

Nirmatrelvir API Specification

☐  Total impurities: Not more than 1.0% w/w

☐ Any unspecified impurity: Not more than 0.1% w/w

☐ Assay by HPLC: Not less than 98% w/w and not more than 102% w/w

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 Nirmatrelvir API

Nirmatrelvir API is a key component in antiviral medications, especially for COVID-19. It is used in combination with Ritnovair (also known as Paxlovid) to treat mild to moderate coronavirus. .

Therapeutic Uses and Indications of Nirmatrelvir

In the US, Europe, and Canada, nirmatrelvir, in combination with ritonavir, is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

How Nirmatrelvir API Works (Mechanism of Action)

Nirmatrelvir is an inhibitor of a cysteine residue in the 3C-like protease (3CLPRO) of SARS-CoV-2. This cysteine is responsible for the activity of the 3CLPRO of SARS-CoV-2 and potentially other members of the coronavirus family. The 3CLPRO, also known as the main protease or non-structural protein 5, is responsible for cleaving polyproteins 1a and 1ab. These polyproteins contain the 3CLPRO itself, a papain-like (PL) cysteine protease, and 14 other nonstructural proteins. Without the activity of the 3CLPRO, nonstructural proteins (including proteases) cannot be released to perform their functions, inhibiting viral replication.

Why Choose Bio-Synth for Nirmatrelvir API

Bio-Synth adheres to stringent quality protocols to ensure that each batch of Nirmatrelvir 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 Nirmatrelvir API in our 60kL WHO-GMP, ISO certified facility with a capacity of 50 kg/month.

Advantages and Key Features of Nirmatrelvir API

☐ Targeted action against SARS-CoV-2, inhibiting viral replication effectively.

☐ Orally bioavailable

☐ Can be prescribed to patients before they require hospitalization

Bio Synth: Nirmatrelvir API Suppliers in India

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

Nirmatrelvir API Price in India

Bio Synth is a reputable supplier of pharmaceutical APIs and intermediates, including Nirmatrelvir API, used to treat flu virus. Bio-Synth offers Nirmatrelvir 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)

We are listening.

We believe that the heart of dialogue is listening.
Please write in your queries and we will get back to you.


    Nirmatrelvir is an oral protease inhibitor with emergency use authorization for the treatment of mild-to-moderate COVID-19
    Nirmatrelvir is most commonly used along with Ritonavir, known as Paxlovid, for the treatment of certain patients with mild-to-moderate COVID-19.
    Bio-Synth offers premium-quality Nirmatrelvir 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 Nirmatrelvir API in India, offering top quality, competitive prices, and short lead time.

    The chemical composition of Nirmatrelvir API is C23H32F3N5O4, which stands for (1R,2S,5S)-N-[(1S)-1-cyano-2-[(3S)-2-oxopyrrolidin-3-yl]ethyl]-3-[(2S)-3,3-dimethyl-2-[(2,2,2-trifluoroacetyl)amino]butanoyl]-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide

    Yes, Nirmatrelvir API is available for purchase in India. Bio-synth is one of the leading manufacturers and suppliers of the 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 Nirmatrelvir 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 Nirmatrelvir API that meets global standards like WHO-GMP and ISO 9000:2015 certification. Our rigorous quality control ensures a consistent and reliable Nirmatrelvir API supply, making us a top choice for Nirmatrelvir 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 Nirmatrelvir 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.