WHO Prequalifies Shanchol® Oral Cholera Vaccine — Ensuring Global Supply Continuity
Hyderabad, India – October, 2025 — Shanchol®, the oral cholera vaccine originally developed by Shantha Biotechnics, has been re-prequalified by the World Health Organization (WHO), ensuring continued access to this essential vaccine for countries battling cholera outbreaks.
This WHO prequalification enables global agencies including UNICEF, Gavi, and PAHO to procure Shanchol® for public health use worldwide.
“Shanchol® was conceived as an affordable, accessible solution for countries facing repeated cholera outbreaks. The WHO prequalification of Shanchol carries forward that founding mission,” said Dr. K.I. Varaprasad Reddy, Founder of Shantha Biotechnics.
Global Impact and Supply Revival
To date, nearly 40 million doses of Shanchol® have been distributed globally through UNICEF-led vaccination campaigns.
After a production pause under its previous ownership, GCBC Vaccines Pvt. Ltd. (formerly Shantha Biotechnics) has resumed manufacturing, with WHO conducting an on-site inspection and transferring prequalification status.
Shanchol® remains the only WHO-prequalified oral cholera vaccine manufactured in India, reinforcing the nation’s key role in maintaining global vaccine supply chains.
“By resuming production of Shanchol®, we’re ensuring that this life-saving vaccine remains available worldwide,” said Dr. Ravi Penmetsa, Managing Director, GCBC Vaccines Pvt. Ltd.
“This milestone underscores Shantha’s renewed commitment to global health. We’re working to ensure reliable, affordable access to vaccines like Shanchol® and to expand our pipeline for global markets,” added Dr. Vishy Chebrol, Director, GCBC Vaccines Pvt. Ltd.
About Shanchol®
Shanchol® is a bivalent killed whole-cell oral cholera vaccine, effective against Vibrio cholerae O1 and O139.
It has been a cornerstone of cholera outbreak response and preventive immunization programs coordinated by UNICEF and WHO, protecting millions worldwide.
With WHO prequalification, Shanchol® will continue to be produced at scale to meet both international emergency stockpile needs and routine immunization demand.
About GCBC Vaccines Pvt. Ltd.
Originally founded as Shantha Biotechnics, one of India’s first biotech pioneers in the 1990s, the company gained international recognition under Sanofi’s ownership after 2009.
In 2024, GCBC Vaccines Pvt. Ltd. acquired Shantha’s facilities and portfolio, reviving its legacy with a mission to deliver high-quality, affordable vaccines to the world.
🌐 Learn more: https://gcbcvaccines.com
📄 Full press release: Read PDF
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