Oseltamivir Phosphate API Manufacturers & Suppliers in India

Oseltamivir API, is an antiviral neuraminidase inhibitor used for the treatment and prophylaxis of infection with influenza viruses A (including pandemic H1N1) and B. Oseltamivir exerts its antiviral activity by inhibiting the activity of the viral neuraminidase enzyme found on the surface of the virus, which prevents budding from the host cell, viral replication, and infectivity.

The clinical benefit of the use of oseltamivir is greatest when administered within 48 hours of the onset of influenza symptoms since effectiveness decreases significantly after that point in time; there is generally no benefit in use beyond 48 hours for healthy, low-risk individuals as influenza is a self-limiting illness. However, antiviral treatment might be beneficial when initiated after 48 hours for patients with severe, complicated, or progressive illness or hospitalized patients.

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Product Description

Product Description

Generic Name: Oseltamivir Phosphate API

Chemical Name : Ethyl (3R,4R,5S)-5-amino-4-acetamido-3-(pentan-3-yloxy)-cyclohex-1-ene-1-carboxylate

Molecular weight: 410.40 g/mol

Molecular formula: C16H31N2O8P

Category: Neuraminidase Inhibitors

Therapeutic use:  Used in the treatment of the infection caused by the flu virus (influenza A and influenza B)

Form: Powder

Color: White to off-white

Size of package: As per requirement

Synonyms: Oseltamivir, (3R,4R,5S)-4-Acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid ethyl ester phosphate salt

Solubility: Freely soluble in water, soluble in DMSO, and slightly soluble in DMF

Oseltamivir Phosphate API Specification

  • ☐ Total impurities: Not more than 1.0% w/w
  • ☐ Any unspecified impurity: Not more than 0.5% 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 Oseltamivir Phosphate API

Oseltamivir belongs to the family of medicines called antivirals, which are used to treat infections caused by viruses. Oseltamivir is used in the treatment of infections caused by the flu virus (influenza A and influenza B). Oseltamivir may also be used to prevent and treat swine influenza A.

Therapeutic Uses and Indications of Oseltamivir Phosphate

According to FDA prescribing information, oseltamivir is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. In particular, this agent is indicated in adults and children, including full-term neonates who present with symptoms typical of influenza when the influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of the first onset of symptoms.

Oseltamivir is also indicated for the prophylaxis of influenza in patients one year and older. Specifically, post-exposure prevention in individuals one year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community qualifies for such prophylactic therapy. Oseltamivir would only be indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak

How Oseltamivir Phosphate API Works (Mechanism of Action)

Oseltamivir phosphate is a pro-drug of the active metabolite (oseltamivir carboxylate) which is a potent and selective inhibitor of influenza virus neuraminidase enzymes, which are glycoproteins found on the virion surface. Viral neuraminidase enzyme activity is important for viral entry into uninfected cells, for the release of recently formed virus particles from infected cells, and for the further spread of the infectious virus in the body. Oseltamivir activity reduces viral shedding and infectivity.

Oseltamivir is effective against viral neuraminidases of influenza A (including pandemic H1N1) and influenza B

Why Choose Bio-Synth for Oseltamivir Phosphate API

Bio-Synth offers high-purity, pharma-grade API with global regulatory compliance. Reliable supply chain, timely delivery, and strong technical support for clients.

Bio-Synth adheres to stringent quality protocols to ensure that each batch of Oseltamivir 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 Oseltamivir API in our 60kL WHO-GMP, ISO certified facility with a capacity of 500 kg/month.

Bio Synth: Oseltamivir Phosphate API Suppliers in India

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

Oseltamivir Phosphate API Price in India

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

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    Oseltamivir is a Neuraminidase inhibitor used to treat the flu virus (Influenza A and B).

    Bio-Synth offers premium-quality Oseltamivir 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 Oseltamivir API in India, offering top quality, competitive prices, and short lead time.

    Oseltamivir Phosphate API is used to treat the flu virus (Influenza A and B).

    The chemical composition of Oseltamivir API is C16H31N2O8P- ensure numbers are in subscript, which stands for Ethyl (3R,4R,5S)-5-amino-4-acetamido-3-(pentan-3-yloxy)-cyclohex-1-ene-1-carboxylate

    Yes, Oseltamivir 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 Oseltamivir 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 Oseltamivir API that meets global standards like WHO-GMP and ISO 9000:2015 certification. Our rigorous quality control ensures a consistent and reliable Oseltamivir API supply, making us a top choice for Dapagliflozin 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 Oseltamivir 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.