Serum - Protection from birth onwards
India, Pune, June 10th, 2025: In light of the recent Prequalification (PQT) Unit published and implemented by WHO, Serum Institute of India (SII) Pvt. Ltd., part of Cyrus Poonawalla Group, the world’s largest vaccine manufacturer, is proud to announce a significant regulatory milestone. SIIPL has become the first vaccine manufacturer to submit a Prequalification Dossier (PQD) for a vaccine in the electronic Common Technical Document (eCTD) format through the newly launched WHO ePQS submission portal.
The ePQS portal, opened to external users on 19th May 2025 by the WHO Prequalification (PQT) Unit, is a fully integrated electronic platform intended to support the complete lifecycle of product prequalification. SIIPL’s submission on 30th May 2025 marks a pioneering use of this digital system for vaccine dossiers.
The achievement was made possible through close collaboration with the WHO ePQS Team, as part of a pilot program that tested and validated the eCTD-based electronic submission process. The SIIPL PQD submission has been successfully validated in the ePQS portal by the WHO-PQ office, reinforcing SIIPL’s commitment to regulatory innovation and quality.
As a company dedicated to delivering affordable and high-quality vaccines across the globe, SIIPL is proud to support WHO’s mission of strengthening public health systems through efficient, transparent, and technology-enabled processes.
Further information on the portal can be located at this link:
https://extranet.who.int/prequal/epqs/epqs-portal
About SII (Serum Institute of India)
Serum Institute of India Pvt. Ltd., part of Cyrus Poonawalla Group is a global leader in vaccine manufacturing, dedicated to providing affordable vaccines worldwide. Present across 170+ countries, including the US, UK, and Europe, SII holds the distinction of being the world's largest vaccine manufacturer. SIIPL's multifunctional production and one-of-the-largest facilities in Hadapsar & Manjari, Pune, with an annual capacity of 4 billion doses, has saved over 30 million lives over the years.
Founded in 1966, SIIPL's primary mission is to produce life-saving immunobiological drugs, with a particular emphasis on affordability and accessibility. Guided by a strong commitment to improving global health, the company has played a pivotal role in reducing the prices of essential vaccines, such as Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps, and Rubella. Notably, they are the manufacturers of 'Pneumosiil,' the world's most affordable PCV, 'Cervavac' the first indigenous qHPV vaccine in India, and R21/Matrix-M™, the second Malaria vaccine to be authorized for use in children in malaria-endemic regions, ‘MenFive’, the first in the world Pentavalent (ACYWX) Meningococcal Polysaccharide Conjugate Vaccine, approved and WHO-prequalified for use in the pediatric population. Moreover, SIIPL has been at the forefront of the global fight against COVID-19, delivering over 2 billion doses of the COVID-19 vaccine worldwide.
To further expand its global presence and ensure widespread vaccine availability, SII has established Serum Life Sciences Ltd, a subsidiary in the UK and Serum Inc., a subsidiary in the US. Through relentless pursuit of innovation, SII continues to champion the cause of affordable vaccines, making a positive impact on the lives of millions worldwide. www.seruminstitute.com
Serum Institute of India
Mayank Sen
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