ROTAVAC® expects India licensure during 2014 and WHO Prequalification in 2015 for supply to UN agencies. The Vaccine is currently undergoing Phase III clinical development for safety and efficacy in 8000 subjects, one of the largest such clinical trial ever conducted in India. According to CDC estimates, rotavirus causes approximately 352,000–592,000 deaths each year (median, 440,000 deaths) in children
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Bharat Biotech International Limited, Hyderabad, India, is a multidimensional biotechnology company specializing in product-oriented research, development, manufacturing of vaccines and bio-therapeutics. Bharat Biotech was established in the year 1996 in Hyderabad, India, & has continuously raised the bar in setting new standards for research, development & commercialization of path breaking technologies through innovation and collaborative research.
Bharat Biotech is one of the first bio-pharma facilities in India to be audited and approved by Korean Food & Drugs Administration (KFDA). Bharat Biotech is also a WHO prequalified manufacturer of Hepatitis-B vaccines for supply to UNICEF and global procurement agencies. Bharat Biotech is one of the largest manufacturers of anti-rabies vaccines.