Company says it will be able to produce an estimated 12 million doses per month
Sanofi has entered into an agreement with Janssen Pharmaceutical NV and Janssen Pharmaceuticals, Inc., two of the Janssen pharma companies of Johnson & Johnson, to help manufacture Janssen's Covid-19 vaccine. Janssen has submitted an application to FDA requesting Emergency Use Authorization (EUA) for its single-dose vaccine candidate, along with an application for conditional marketing authorization to the European Medicines Agency (EMA).
Once authorized, Sanofi will provide J&J access to its vaccine manufacturing plant in Marcy l’Etoile, France, in order to formulate and fill vials of the vaccine this year, at a rate of about 12 million doses per month.
Last month, Sanofi announced an agreement with Pfizer/BioNTech to manufacture and supply more than 125 million doses of their Covid-19 vaccine.
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.