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Жел . 05, 2024 15:24 Back to list

cas 204255-11-8 oseltamivir phosphate manufacturer



Oseltamivir Phosphate An Overview of the CAS No. 204255-11-8 and Its Manufacturers


Oseltamivir phosphate, commonly known under its trade name Tamiflu, is an antiviral medication primarily used for the treatment and prevention of influenza, particularly during flu season. Identified by the Chemical Abstracts Service (CAS) number 204255-11-8, this drug is an ester prodrug that is converted in the body to oseltamivir carboxylate, its active form. This active metabolite inhibits the neuraminidase enzyme found on the surface of the influenza virus, preventing the release of new viral particles from infected cells and stopping the spread of the virus in the body.


The synthesis of oseltamivir phosphate requires a careful approach due to its complex chemical structure. Manufacturers must adhere to strict regulatory standards to ensure the purity and quality of the drug. The production involves multiple steps, including the synthesis of the core structure, phosphorylation, and formulation into a suitable dosage form for patients. This process is not only technical but also requires significant investment in quality control and laboratory capabilities to ensure compliance with safety standards.


Key Manufacturers


The global market for oseltamivir phosphate is dominated by several key manufacturers, which play a crucial role in the availability of this essential antiviral medication

. Some of the noteworthy companies involved in the production of oseltamivir phosphate include

1. Roche As the original developer of the drug, Roche holds significant intellectual property rights over oseltamivir. The company developed the drug in collaboration with Gilead Sciences, and it remains a leading player in the influenza treatment market. Roche has invested substantially in the research and development of antiviral therapies, reinforcing its commitment to public health.


2. Generic Manufacturers With the patent for oseltamivir expiring, numerous generic pharmaceutical companies started producing oseltamivir phosphate. Companies such as Mylan, Teva Pharmaceuticals, and Aurobindo Pharma have all entered the market to provide affordable alternatives to the brand-name drug. These companies comply with regulatory standards set forth by health authorities to ensure that their products are bioequivalent to the original formulation.


cas 204255-11-8 oseltamivir phosphate manufacturer

cas 204255-11-8 oseltamivir phosphate manufacturer

3. Asia-Pacific Manufacturers A significant number of manufacturers are based in the Asia-Pacific region, especially in countries like India and China, where the pharmaceutical industry has rapidly developed. These manufacturers produce oseltamivir phosphate not only for their domestic markets but also cater to international demands. They play a crucial role in ensuring the drug's availability during flu pandemics, as was evident during the H1N1 outbreak in 2009.


Regulatory Considerations


Manufacturers of oseltamivir phosphate must navigate a complex landscape of regulations and guidelines enforced by health authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These organizations mandate rigorous testing and quality assurance processes to ensure that all marketed forms of oseltamivir phosphate are safe and effective.


Additionally, during health emergencies, regulatory bodies can expedite the review process for new submissions related to oseltamivir phosphate to ensure swift availability of the drug. This was particularly true during flu seasons characterized by high infection rates or during outbreaks, where rapid production and distribution became vital.


Conclusion


Oseltamivir phosphate, with its CAS number 204255-11-8, remains an integral part of modern antiviral therapies for influenza. Its unique mechanism of action, combined with the efforts of various manufacturers, ensures its continued availability worldwide. As the landscape of healthcare evolves, ongoing investments in research, manufacturing, and regulatory compliance will be essential to maintaining the efficacy and availability of oseltamivir phosphate, especially in the face of emerging viral threats. Understanding the role of key manufacturers and the regulatory framework surrounding this drug is crucial for both healthcare providers and patients alike.


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