FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

WHO Prequalifies Shanghai Manufacturer’s API Atazanavir

June 12, 2019

The World Health Organization granted prequalification status to Shanghai Desano Chemical Pharmaceutical’s Atazanavir (sulfate).

The antiretroviral drug is used to treat HIV and can help to slow the disease’s progression and extend a patient’s lifespan through use in drug combinations.

The WHO’s prequalification is used to identify APIs manufactured in line with the organization’s GMP standards. Ingredients that make the cut are included in the WHO’s list of prequalified APIs.

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